64Cu-SAR-BBN Positron Emission Tomography: A Phase 2 Study of Participants With PSMA-negative Biochemical Recurrence of Prostate Cancer
Phase: PHASE2
Conditions: Biochemical Recurrence of Malignant Neoplasm of Prostate
Sponsor: Clarity Pharmaceuticals Ltd

   
 
 
 
 
 
64Cu-SAR-BBN Positron Emission Tomography: A Phase 2 Study of 
Participants with PSMA-negative Biochemical Recurrence of Prostate Cancer 
Protocol: CLB03 
 
 
 
CLINICAL STUDY PROTOCOL 
Version 2.0 
February 27, 2023 
 
 
NCT05407311 
 
 
 
 
 

Investigational Product: 64Cu-SAR-BBN  
 Clarity Pharmaceuticals Ltd 
Protocol: CLB03  
 Version: 2.0, 27Feb2023 
 
CONFIDENTIAL 
Page 2 of 74 
SPONSOR PROTOCOL APPROVAL 
Protocol Title: 
64Cu-SAR-BBN Positron Emission Tomography: A Phase 2 
Study of Participants with PSMA-negative Biochemical 
Recurrence of Prostate Cancer  
Protocol Number: 
CLB03 
Protocol Version 
(Date): 
2.0 (27-Feb-2023) 
 
This version of the clinical protocol has been approved by Clarity Pharmaceuticals Ltd. 
 
 
 
 
 
 
 
 
Clarity Pharmaceuticals Ltd 
 
Date 
 
 

Investigational Product: 64Cu-SAR-BBN  
 Clarity Pharmaceuticals Ltd 
Protocol: CLB03  
 Version: 2.0, 27Feb2023 
 
CONFIDENTIAL 
Page 3 of 74 
PROTOCOL SYNOPSIS 
Protocol Number 
CLB03 
Investigational 
Product 
64Cu-SAR-BBN 
Protocol Title 
64Cu-SAR-BBN Positron Emission Tomography: A Phase 2 Study 
of Participants with PSMA-negative Biochemical Recurrence of 
Prostate Cancer 
Short Title 
SABRE (Copper-64 SAR-BBN in Biochemical REcurrence of 
Prostate Cancer) 
Phase 
2 
IND Number 
161210 
Study Sponsor 
Clarity Pharmaceuticals Ltd. 
Study Centers 
Planned 
Multi-center 
Study Design 
This is a multi-center, single arm, non-randomized, open-label study of 
Copper-64-labeled 
SAR-BBN 
(64Cu-SAR-BBN) 
administered 
to 
participants with biochemical recurrence of prostate cancer (PC) 
following definitive therapy. Participants who provide informed consent 
will undertake a screening visit(s) to determine their eligibility to 
participate in the study. The maximum Screening period for each 
participant is 28 days. After the Screening period, eligible participants will 
receive a single administration of 64Cu-SAR-BBN on Day 0, followed by 
a positron emission tomography (PET)/computed tomography (CT) scan 
at 1 to 4 hours post dose (Day 0 scan) and at 24 hours post dose (Day 1 
scan). Safety of 64Cu-SAR-BBN will be assessed post dose, on Day 0, Day 
1 and Day 7. Participants will then continue into the Follow-Up period to 
verify the 
64Cu-SAR-BBN PET/CT findings by histopathology, 
conventional imaging modalities that are routinely used in the diagnosis 
and staging of PC and prostate-specific antigen (PSA) levels. The 
maximum Follow-up period for each participant is 180 days. 
The 64Cu-SAR-BBN PET/CT scans will be interpreted by an appropriately 
qualified local Investigator and three independent, blinded central readers.  
The 64Cu-SAR-BBN PET/CT findings will be assessed against a 
composite Reference Standard. The composite Reference Standard will be 
determined by an independent, blinded, central expert panel and may 
consist of histopathology, conventional imaging modalities that are 
routinely used in the diagnosis and staging of PC and PSA levels. 
Primary Study Objectives and Endpoints 
Objective 
Endpoint 
To investigate the safety and 
tolerability of 64Cu-SAR-BBN. 
Incidence and severity of treatment-emergent AEs and 
SAEs following the administration of 64Cu-SAR-BBN. 
To investigate the ability of 64Cu-
SAR-BBN PET/CT to correctly 
detect recurrence of PC. 
• 
Participant-level CDR, defined as the proportion of TP 
participants on the Day 0 scan out of all participants 
with a Day 0 scan. 

Investigational Product: 64Cu-SAR-BBN  
 Clarity Pharmaceuticals Ltd 
Protocol: CLB03  
 Version: 2.0, 27Feb2023 
 
CONFIDENTIAL 
Page 4 of 74 
• 
Participant-level CDR, defined as the proportion of TP 
participants on the Day 1 scan out of all participants 
with a Day 1 scan. 
• 
Region-level PPV, defined as the proportion of TP 
regions on the Day 0 scan out of all positive regions 
on the Day 0 scan. 
• 
Region-level PPV, defined as the proportion of TP 
regions on the Day 1 scan out of all positive regions 
on the Day 1 scan. 
Abbreviations: AE= adverse event; CDR= correct detection rate; CT= Computed Tomography; PET= 
Positron Emission Tomography; PC= prostate cancer; PPV= positive predictive value; SAE= serious 
adverse event; TP= true positive 
Secondary Study Objectives and Endpoints 
Objective 
Endpoint 
To investigate the biodistribution of 
64Cu-SAR-BBN. 
Biodistribution of 64Cu-SAR-BBN on the Day 0 and Day 
1 scan:  
• 
Maximum and mean SUVs in lesion(s), visceral/soft 
tissue, bone. 
• 
Lesion-to-background ratio. 
To assess the participant-level PPV 
of 64Cu-SAR-BBN PET/CT.  
• 
Participant-level PPV, defined as the proportion of TP 
participants on the Day 0 scan out of all participants 
with a positive Day 0 scan. 
• 
Participant-level PPV, defined as the proportion of TP 
participants on the Day 1 scan out of all participants 
with a positive Day 1 scan. 
To assess the participant-level DR of 
64Cu-SAR-BBN PET/CT.  
• 
Participant-level DR, defined as the proportion of 
participants with a positive Day 0 scan out of all 
participants with a Day 0 scan. 
• 
Participant-level DR, defined as the proportion of 
participants with a positive Day 1 scan out of all 
participants with a Day 1 scan. 
To assess the FPR 64Cu-SAR-BBN 
PET/CT. 
• 
Participant-level FPR, defined as the proportion of FP 
participants on the Day 0 scan out of all participants 
with a positive Day 0 scan. 
• 
Participant-level FPR, defined as the proportion of FP 
participants on the Day 1 scan out of all participants 
with a positive Day 1 scan. 
• 
Region-level FPR, defined as the proportion of FP 
regions on the Day 0 scan out of all positive regions 
on the Day 0 scan. 
• 
Region-level FPR, defined as the proportion of FP 
regions on the Day 1 scan out of all positive regions 
on the Day 1 scan. 

Investigational Product: 64Cu-SAR-BBN  
 Clarity Pharmaceuticals Ltd 
Protocol: CLB03  
 Version: 2.0, 27Feb2023 
 
CONFIDENTIAL 
Page 5 of 74 
To assess the discrepant PET 
negativity rate of the 64Cu-SAR-
BBN PET/CT scans. 
Participant-level discrepant PET negativity rate, defined as 
the proportion of participants with contradicting Day 0 and 
Day 1 results for whom the Reference Standard was 
positive. 
To assess the TNR of 64Cu-SAR-
BBN PET/CT. 
• 
Participant-level TNR, defined as the proportion of TN 
participants on the Day 0 scan out of all participants 
with a negative Day 0 scan. 
• 
Participant-level TNR, defined as the proportion of TN 
participants on the Day 1 scan out of all participants 
with a negative Day 1 scan. 
• 
Region-level TNR, defined as the proportion of TN 
regions on the Day 0 scan out of all negative regions 
on the Day 0 scan. 
• 
Region-level TNR, defined as the proportion of TN 
regions on the Day 1 scan out of all negative regions 
on the Day 1 scan. 
Abbreviations: CT= computed tomography; DR= detection rate; FP= false positive; FPR= rate of false 
positive; PET= positron emission tomography; PPV= positive predictive value; SUV= standardized uptake 
value; TN= true negative; TNR= rate of true negative; TP= true positive 
Exploratory Study Objectives and Endpoints 
Objective 
Endpoint 
To evaluate the reproducibility of the 
64Cu-SAR-BBN PET/CT readings 
and consistency among readers. 
• 
Intra-reader variability per reader. 
• 
Inter-reader variability expressed by kappa statistics. 
To assess the impact of 64Cu-SAR-
BBN 
PET/CT 
on 
disease 
management. 
Proportion of participants with any change in intended PC 
treatment due to either the Day 0 or Day 1 scan. 
Composite performance of the Day 0 
and Day 1 64Cu-SAR-BBN PET/CT 
scans. 
• 
Composite CDR defined as the proportion of TP 
participants on the Day 0 and/or Day 1 scan out of all 
participants with a Day 0 and/or Day 1 scan. 
• 
Composite participant/region-level PPV defined as the 
proportion of TP participants/regions on the Day 0 
and/or Day 1 scan out of all participants/regions with 
a positive Day 0 and/or Day 1 scan.  
• 
Composite DR defined as the proportion of 
participants with a positive Day 0 and/or Day 1 scan 
out of all participants with a Day 0 and/or Day 1 scan. 
To determine the effect of baseline 
variables on the CDR, PPV and DR 
of 64Cu-SAR-BBN PET/CT. 
CDR, participant- and region-level PPV and DR of the Day 
0 and/or Day 1 scan as a function of baseline variables. 
 To explore the correlation between 
64Cu-SAR-BBN PET-positivity and 
Reference Standard results. 
Relationship between PET-positivity (biodistribution 
measures such as SUVs and lesion-to-background ratio), 
versus true/false positivity and as a function of lesion 
location and size. 

Investigational Product: 64Cu-SAR-BBN  
 Clarity Pharmaceuticals Ltd 
Protocol: CLB03  
 Version: 2.0, 27Feb2023 
 
CONFIDENTIAL 
Page 6 of 74 
To 
assess 
the 
lesion-level 
performance 
of 
64Cu-SAR-BBN 
PET/CT. 
• 
Difference in the number of lesions detected per 
participant on the Day 0 versus the Day 1 scan. 
• 
Overall agreement rate on the Day 0 and Day 1 scans, 
defined as the number lesions with matching 
subregion divided by the total number of lesions 
identified across all scans by either imaging.  
• 
Overall agreement rate on the Day 0 and reference 
scans, defined as the number lesions with matching 
subregion divided by the total number of lesions 
identified across all scans by either imaging. 
• 
Overall agreement rate on the Day 1 and reference 
scans, defined as the number lesions with matching 
subregion divided by the total number of lesions 
identified across all scans by either imaging. 
Abbreviations: CDR= correct detection rate; CT= computed tomography; DR= detection rate; PC= prostate 
cancer; PET= positron emission tomography; PPV= positive predictive value; TP = true positive 
Number of 
Participants Planned 
50 
Target Population 
Biochemical recurrence of PC following definitive therapy with negative 
or equivocal PC findings on approved PSMA PET and anatomical 
imaging (CT and/or MRI), and other conventional imaging, if available. 
Inclusion Criteria 
Study candidates must meet all the following criteria to be eligible for the 
study: 
1. At least 18 years of age; 
2. Signed informed consent; 
3. Life expectancy ≥ 12 weeks as determined by the Investigator. 
4. Histologically confirmed adenocarcinoma of prostate per 
original diagnosis and completed subsequent definitive therapy. 
5. Suspected recurrence of PC based on rising PSA after definitive 
therapy on the basis of: 
a. Post-radical prostatectomy: detectable or rising PSA that 
is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL 
(per American Urological Association 
recommendation); or 
b. Post-radiation therapy, cryotherapy, or brachytherapy: 
increase in PSA level that is elevated by ≥ 2 ng/mL 
above the nadir (per American Society for Therapeutic 
Radiology and Oncology-Phoenix consensus definition). 
6. Negative or equivocal findings for PC on (1) approved PSMA 
PET and (2) anatomical imaging (CT and/or magnetic resonance 
imaging) and (3) if available, any other conventional imaging 
performed as part of routine standard of care imaging workup 
within 60 days prior to Day 0. 
7. The Eastern Cooperative Oncology Group performance status 0-
2.  

Investigational Product: 64Cu-SAR-BBN  
 Clarity Pharmaceuticals Ltd 
Protocol: CLB03  
 Version: 2.0, 27Feb2023 
 
CONFIDENTIAL 
Page 7 of 74 
8. Adequate recovery from acute toxic effects of any prior therapy.  
9. Estimated Glomerular Filtration Rate of 30 mL/min or higher.  
10. Adequate liver function defined as alanine 
aminotransferase/aspartate aminotransferase <3 x upper limit of 
normal (ULN) and total bilirubin <1.5 x ULN (except in the case 
of Gilbert’s syndrome). 
11. For participants who have partners of childbearing potential: 
Partner and/or participant must use a method of birth control 
with adequate barrier protection. 
Exclusion Criteria 
Study candidates who meet any of the following criteria are not to be 
enrolled in the study: 
1.  Participants who received other investigational agents within 28 
days prior to Day 0. 
2. Participants administered any high energy (>300 KeV) gamma-
emitting radioisotope within 5 physical half-lives prior to Day 0.   
3. Ongoing treatment or treatment within 90 days of Day 0 with 
any systemic therapy (e.g., androgen-deprivation therapy, 
antiandrogen, gonadotropin-releasing hormone, luteinizing 
hormone-releasing hormone agonist or antagonist) for PC. 
4. Participants who are known to require prohibited treatment (e.g., 
initiation of androgen-deprivation therapy due to rapidly rising 
PSA) before the 64Cu-SAR-BBN PET/CT results can be verified 
via histopathology or follow-up imaging. 
5. Known or expected hypersensitivity to 64Cu-SAR-BBN or any of 
its components. 
6. Any serious medical condition or extenuating circumstance 
which the Investigator feels may interfere with the procedures or 
evaluations of the study. 
Investigational 
Product, Dose, and 
Regimen 
The investigational product administered in this study is 64Cu-SAR-BBN.  
64Cu-SAR-BBN has 3 basic components; the radionuclide (64Cu) bound 
via MeCOSar (a bifunctional metal chelator) to an antagonist that targets 
Gastrin Releasing Peptide Receptor. 
Statistical Methods 
A Statistical Analysis Plan (SAP) will be written after finalizing the 
protocol and prior to database lock. The SAP will detail the 
implementation of all the planned statistical analysis in accordance with 
the principal features stated in the protocol. 

Investigational Product: 64Cu-SAR-BBN  
 Clarity Pharmaceuticals Ltd 
Protocol: CLB03  
 Version: 2.0, 27Feb2023 
 
 CONFIDENTIAL 
 Page 8 of 74 
TABLE OF CONTENTS 
SPONSOR PROTOCOL APPROVAL............................................................................. 2 
PROTOCOL SYNOPSIS ................................................................................................... 3 
TABLE OF CONTENTS ................................................................................................... 8 
List of Tables ................................................................................................................. 11 
List of Figures ................................................................................................................ 11 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ............................... 12 
AMENDMENT 1 (V2.0, 27-FEB-2023) .......................................................................... 14 
1 
INVESTIGATIONAL TEAM ................................................................................... 16 
2 
INTRODUCTION ...................................................................................................... 17 
2.1 
Background .......................................................................................................... 17 
2.2 
Imaging of Prostate Cancer .................................................................................. 18 
2.3 
Preclinical Experience ......................................................................................... 19 
2.4 
Clinical Experience .............................................................................................. 20 
2.5 
Rationale for the Study and Study Design ........................................................... 20 
2.5.1 
Imaging Timepoint Selection .................................................................................. 21 
2.5.2 
Dose Selection of 64Cu-SAR-BBN .......................................................................... 21 
2.6 
Benefit/Risk Assessment ..................................................................................... 22 
3 
STUDY OBJECTIVES AND ENDPOINTS ............................................................ 23 
3.1 
Primary Objectives and Endpoints ....................................................................... 23 
3.2 
Secondary Objectives and Endpoints ................................................................... 23 
3.3 
Exploratory Objectives and Endpoints ................................................................ 24 
4 
STUDY DESIGN ........................................................................................................ 26 
4.1 
Study Overview ................................................................................................... 26 
4.2 
Study Duration, Beginning and End of Study ..................................................... 27 
5 
STUDY ENROLLMENT AND WITHDRAWAL .................................................. 28 
5.1 
Study Population .................................................................................................. 28 
5.1.1 
Inclusion Criteria ..................................................................................................... 28 
5.1.2 
Exclusion Criteria .................................................................................................... 28 
5.2 
Enrollment and Method of Assigning Participants to Treatment Groups ............ 29 
5.3 
Study Blinding ..................................................................................................... 29 
5.4 
Participant Withdrawal and Replacement ............................................................ 29 
5.4.1 
Screening Failures and Rescreening ....................................................................... 29 
5.4.1.1 
Screen Failures............................................................................................... 29 
5.4.1.2 
Rescreening.................................................................................................... 30 
5.4.2 
Withdrawal of Consent and Discontinuation of Participants from the Study ......... 30 
5.4.2.1 
Individual Stopping Rules ............................................................................. 31 
5.4.3 
Pregnancy ................................................................................................................ 31 
5.4.3.1 
Acceptable Forms of Contraception .............................................................. 31 
5.4.3.2 
Sperm Donation ............................................................................................. 32 
5.4.4 
Replacement of Participants .................................................................................... 32 

Investigational Product: 64Cu-SAR-BBN  
 Clarity Pharmaceuticals Ltd 
Protocol: CLB03  
 Version: 2.0, 27Feb2023 
 
 CONFIDENTIAL 
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5.5 
Premature Termination or Suspension of Study .................................................. 32 
5.6 
Safety Review Committee ................................................................................... 32 
6 
INVESTIGATIONAL PRODUCT ........................................................................... 33 
6.1 
Dosage and Formulation ...................................................................................... 33 
6.2 
Supply, Packaging and Labeling .......................................................................... 33 
6.3 
Storage and Stability ............................................................................................ 33 
6.4 
Dispensing and Administration ............................................................................ 33 
6.4.1 
Radiation Protection ................................................................................................ 34 
6.5 
Compliance and Accountability ........................................................................... 34 
6.5.1 
Storage of Supplies ................................................................................................. 34 
6.5.2 
Control of Supplies ................................................................................................. 34 
6.5.3 
Destruction of Supplies ........................................................................................... 34 
6.6 
Investigational Product Administration ............................................................... 35 
6.6.1 
Participant Preparation Prior to Dosing .................................................................. 35 
6.6.2 
Selection of Dose of 64Cu-SAR-BBN ..................................................................... 35 
6.7 
Participant Release and Radioprotection Precautions .......................................... 35 
7 
CONCOMITANT MEDICATIONS ........................................................................ 36 
7.1 
Required Treatments ............................................................................................ 36 
7.2 
Permitted Treatments ........................................................................................... 36 
7.3 
Prohibited Treatments .......................................................................................... 36 
8 
STUDY PROCEDURES AND ASSESSMENTS .................................................... 37 
8.1 
Demographics and Baseline Health Record ........................................................ 40 
8.1.1 
Baseline Demographics ........................................................................................... 40 
8.1.2 
Medical and Medication History ............................................................................. 40 
8.1.3 
Prior Cancer Treatments and Therapies .................................................................. 40 
8.2 
Safety Assessments .............................................................................................. 40 
8.2.1 
Physical Examination .............................................................................................. 40 
8.2.2 
Body Weight and Height ......................................................................................... 40 
8.2.3 
Eastern Cooperative Oncology Group Performance Status .................................... 41 
8.2.4 
Vital Signs ............................................................................................................... 41 
8.2.5 
12-lead Electrocardiogram ...................................................................................... 41 
8.2.6 
Clinical Laboratory Safety Assessments ................................................................. 41 
8.2.7 
Total Prostate Specific Antigen ............................................................................... 42 
8.3 
Imaging Assessments ........................................................................................... 42 
8.3.1 
Baseline Conventional Scans .................................................................................. 42 
8.3.2 
64Cu-SAR-BBN PET/CT ......................................................................................... 43 
8.3.2.1 
64Cu-SAR-BBN PET/CT Local Interpretation .............................................. 43 
8.3.2.2 
64Cu-SAR-BBN PET/CT Central Interpretation ............................................ 43 
8.3.3 
Follow-up Conventional Imaging ........................................................................... 44 
8.4 
Histopathology ..................................................................................................... 44 
8.5 
Prostate Cancer Treatments ................................................................................. 45 
8.6 
Diagnostic Efficacy Assessments ........................................................................ 45 
8.6.1 
Assessment of the Composite Reference Standard ................................................. 45 
8.6.2 
Assessment of Reference Standard against the 64Cu-SAR-BBN PET/CT Results . 46 
8.6.3 
Disease Management Plan ...................................................................................... 47 
8.7 
Pharmacokinetics ................................................................................................. 48 
8.7.1 
Biodistribution of 64Cu-SAR-BBN ......................................................................... 48 
9 
VISIT-SPECIFIC PROCEDURES .......................................................................... 49 

Investigational Product: 64Cu-SAR-BBN  
 Clarity Pharmaceuticals Ltd 
Protocol: CLB03  
 Version: 2.0, 27Feb2023 
 
 CONFIDENTIAL 
 Page 10 of 74 
9.1.1 
Screening Period ..................................................................................................... 49 
9.1.1.1 
Visit 1 (Day -28 to Day 0) ............................................................................. 49 
9.1.2 
64Cu-SAR-BBN PET/CT Imaging .......................................................................... 49 
9.1.2.1 
Visit 2 (Day 0) ............................................................................................... 49 
9.1.2.2 
Visit 3 (24 hours ±6 hours Post Dose, Day 1) ............................................... 50 
9.1.3 
Safety Visit .............................................................................................................. 50 
9.1.3.1 
Visit 4 (Day 7 ± 2 days) ................................................................................. 50 
9.1.4 
Follow-Up ............................................................................................................... 50 
9.1.4.1 
Visit 5 (Day 90 ± 15 days) ............................................................................. 50 
9.1.4.2 
Visit 6 (Day 180 ± 15 days) ........................................................................... 51 
10 ADVERSE EVENT MONITORING ....................................................................... 52 
10.1 Adverse Events .................................................................................................... 52 
10.1.1 
Adverse Drug Reaction ........................................................................................... 52 
10.1.2 
Unexpected Adverse Drug Reaction ....................................................................... 53 
10.1.3 
Assessment of Adverse Events by the Investigator ................................................. 53 
10.1.3.1 
Assessment of Severity .................................................................................. 53 
10.1.3.2 
Causality Assessment .................................................................................... 53 
10.2 Serious Adverse Event ......................................................................................... 54 
10.3 Serious Adverse Event Reporting – Procedures for Investigators ....................... 55 
10.3.1 
Initial Reports .......................................................................................................... 55 
10.3.2 
Follow-Up Reports .................................................................................................. 55 
10.4 Pregnancy ............................................................................................................. 55 
10.5 Expedited Reporting ............................................................................................ 55 
11 STATISTICAL METHODS ..................................................................................... 57 
11.1 General Considerations ........................................................................................ 57 
11.2 Analysis Populations ............................................................................................ 57 
11.2.1 
Enrolled Analysis Set .............................................................................................. 57 
11.2.2 
Safety Analysis Set ................................................................................................. 57 
11.2.3 
Full Analysis Set ..................................................................................................... 57 
11.2.4 
Biodistribution Population ...................................................................................... 57 
11.3 Determination of Sample Size ............................................................................. 57 
11.4 Analysis Methods ................................................................................................. 58 
11.4.1 
Enrollment and Disposition ..................................................................................... 58 
11.4.2 
Demographic and Other Baseline Characteristics ................................................... 58 
11.4.3 
Prior and Concomitant Medication ......................................................................... 58 
11.4.4 
Safety Analysis ........................................................................................................ 58 
11.4.4.1 
Adverse Event Analysis ................................................................................. 58 
11.4.4.2 
Laboratory Data Analysis .............................................................................. 59 
11.4.4.3 
Vital Sign Analysis ........................................................................................ 59 
11.4.4.4 
Electrocardiogram Analysis ........................................................................... 59 
11.4.5 
Efficacy Analysis .................................................................................................... 59 
11.4.5.1 
Primary Efficacy Analyses ............................................................................ 59 
11.4.5.2 
Secondary Efficacy Analyses ........................................................................ 60 
11.4.5.3 
Exploratory Efficacy Analyses ...................................................................... 61 
11.4.6 
Intra- and Inter-reader Reliability Assessments ...................................................... 62 
11.4.7 
Biodistribution Analysis .......................................................................................... 62 
11.5 Interim Analysis ................................................................................................... 62 
11.6 Handling of Missing Data .................................................................................... 62 
12 STUDY ADMINISTRATION AND RESPONSABILITIES ................................. 63 
12.1 General Investigator Responsibilities .................................................................. 63 

Investigational Product: 64Cu-SAR-BBN  
 Clarity Pharmaceuticals Ltd 
Protocol: CLB03  
 Version: 2.0, 27Feb2023 
 
 CONFIDENTIAL 
 Page 11 of 74 
12.2 Protocol Compliance ............................................................................................ 63 
12.3 Compliance with Ethical and Regulatory Guidelines .......................................... 63 
12.4 Institutional Review Board .................................................................................. 64 
12.5 Informed Consent Process ................................................................................... 64 
12.6 Confidentiality ..................................................................................................... 65 
12.7 Study Files and Retention of Records and Biological Samples ........................... 66 
12.8 Participant Screening Log .................................................................................... 67 
12.9 Modifications of the Protocol or Informed Consent Documents ......................... 67 
12.10 Case Report Forms ............................................................................................... 68 
12.11 Clinical Monitoring .............................................................................................. 68 
12.12 Inspections ........................................................................................................... 68 
12.13 Data Management ................................................................................................ 69 
12.14 Clinical Study Insurance ...................................................................................... 69 
12.15 Communications with Regulatory Authorities .................................................... 69 
12.16 Publication and Information Disclosure Policy ................................................... 69 
12.17 Study Discontinuation .......................................................................................... 70 
REFERENCES .................................................................................................................. 71 
13 INVESTIGATOR AGREEMENT ........................................................................... 74 
 
List of Tables 
Table 1 Primary Study Objectives and Endpoints ............................................................ 23 
Table 2 Secondary Study Objectives and Endpoints ........................................................ 23 
Table 3 Exploratory Study Objectives and Endpoints ...................................................... 25 
Table 4 Investigational Product Administered ................................................................. 33 
Table 5 Schedule of Assessments ..................................................................................... 38 
Table 6 Eastern Cooperative Oncology Group Performance Status Scale ....................... 41 
 
List of Figures 
Figure 1 Overall Study Design ......................................................................................... 27 
 

Investigational Product: 64Cu-SAR-BBN  
 Clarity Pharmaceuticals Ltd 
Protocol: CLB03  
 Version: 2.0, 27Feb2023 
 
 CONFIDENTIAL 
 Page 12 of 74 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation/Term Definition 
18F 
fluorine-18 
18F-FACBC 
 18F-fluciclovine; registered as Axumin® 
18F-FDG 
18F-fluorodeoxyglucose 
18F-NaF 
18F-sodium fluoride 
64Cu 
copper-64 
64Cu-SAR-BBN 
64Cu-labeled SAR-BBN 
67Cu 
copper-67 
68Ga 
gallium-68 
68Ga-RM2 
gallium-68-labeled GRPR targeting agent 
99mTc-MDP 
99mTc-methylene diphosphonate 
ADT 
androgen-deprivation therapy 
AE 
adverse event 
CDR 
correct detection rate 
CI 
confidence interval 
CKD-EPI 
Chronic Kidney Disease Epidemiology Collaboration 
natCu-SAR-BBN 
Natural copper-labeled SAR-BBN 
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
DICOM 
Digital Imaging and Communications in Medicine 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
EDT 
electronic data capture 
eGFR 
estimated Glomerular Filtration Rate 
FAS 
full analysis set 
FDA 
Food and Drug Administration 
FP 
false positive 
GCP 
Good Clinical Practice 
GRP 
gastrin releasing peptide 
GRPR 
gastrin releasing peptide receptor 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
IRB 
institutional review board 
IV 
intravenous 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRI 
magnetic resonance imaging 
natCu 
natural stable Cu 

Investigational Product: 64Cu-SAR-BBN  
 Clarity Pharmaceuticals Ltd 
Protocol: CLB03  
 Version: 2.0, 27Feb2023 
 
 CONFIDENTIAL 
 Page 13 of 74 
Abbreviation/Term Definition 
NCI 
National Cancer Institute 
PC 
prostate cancer 
PET 
positron emission tomography 
PPV 
positive predictive value 
ProstaScint® 
111In-labeled-capromab-pendetide 
PSA 
prostate-specific antigen 
PSADT 
PSA doubling time 
PSMA 
prostate specific membrane antigen 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SAR-BBN 
MeCOSar-PEG4-D-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2 
SOC 
standard of care 
SUV 
standardized uptake value 
t1/2 
half-life 
TEAE 
treatment emergent adverse event 
TN 
true negative 
TP 
true positive 
ULN 
upper limit of normal 
USA 
United States of America 
WBC 
white blood cells count 
 
 
 

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AMENDMENT 1 (V2.0, 27-FEB-2023) 
Amendment rationale and summary of changes: 
The purpose of this amendment is to address recommendations provided by Investigators, to 
provide clarifications on study assessments, analyses of data and to address minor 
typographical errors.  
Summary of Changes 
Section Reference  
Version 2.0, 27-FEB-2023 
Amendment Description 
Throughout the protocol 
Version and date of the document has been updated. 
Throughout the protocol 
Typographical, formatting corrections, administrative changes, and text 
clarifications. 
Section 4.1, Section 7.3, Table 
5, Section 8.2.7, Section 8.6.1, 
Section 8.6.2 
List of prohibited treatments amended to allow for any focal salvage therapy. 
PSA response following any focal salvage therapy is to be monitored every 
4 weeks from the initiation of any salvage focal therapy (in the same way as 
after radiation therapy). Histopathological confirmation of PC prior to 
commencement of radiation or other salvage focal therapy is strongly 
encouraged.  
Section 4.1, Section 8.4, Table 
5 
Clarification added regarding histopathology requirements: If clinically 
feasible, the Investigator should make every effort to obtain histopathology 
for at least one 64Cu-SAR-BBN PET-positive lesion per region. 
Section 5.1.2 
Exclusion criteria added: Participants who are known to require prohibited 
treatment (e.g., initiation of ADT due to rapidly rising PSA) before the 
64Cu-SAR-BBN PET/CT results can be verified via histopathology or 
follow-up imaging.   
Section 5.4.4 
Clarification included regarding the participant replacement criteria: 
Participants who do not complete all required study visits (including those 
who receive prohibited treatment and are discontinued early) may be 
replaced if needed to achieve the target sample size. 
Section 7 
Note added: Participants who are known to require prohibited treatment 
(e.g., initiation of ADT due to rapidly rising PSA) before the 64Cu-SAR-
BBN PET/CT results can be verified via histopathology or follow-up 
imaging should not be considered for participation in this study.   
Section 7.3 
Clarification added: Participants who receive prohibited treatment(s) 
should remain in the study until completion of Visit 4. 
Section 8.2.6 
Removal of the note referencing assessment of triglycerides. Clarification 
added regarding assessment of significance for abnormal PSA values. 
Section 8.3.2.2 
Definition included for equivocal 64Cu-SAR-BBN PET-lesions. 
Section 8.4 
Removal of the requirement for the local pathologist evaluating samples to 
be blinded to the 64Cu-SAR-BBN PET/CT results. 
Section 8.6.1 
Region- and subregion-level requirements for a positive Reference 
Standard status included.  
Section 8.6.1, Section 8.6.2 
Handling of equivocal / unequivocal lesions and non-evaluable and 
inconclusive results in the analyses was clarified. Clarification included 
regarding the process of matching of the Reference Standard against the 
64Cu-SAR-BBN PET/CT results. 
Section 11.4.5, Section 11.6 
Clarification of the CDR endpoint calculation and requirements for 
reference standard datapoints added. Participants with non-evaluable 

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Summary of Changes 
Section Reference  
Version 2.0, 27-FEB-2023 
Amendment Description 
participant-level Reference Standard results will be excluded from the CDR 
calculation. 
Removal of non-evaluable regions from the analysis of region-level PPV 
endpoint. PET/CT positive regions without corresponding evaluable 
composite Reference Standard results will no longer be included in the 
denominator for the region-level PPV calculation. 
Removal of the sensitivity analyses of the participant-level CDR and 
region-level PPV based on participants in the full analysis set who had 
evaluable composite Reference Standard results. 
Section 11.4.5.3 
Assessment of CDR, PPV and DR as a function of anatomic region 
removed.  
Abbreviations: ADT= androgen-deprivation therapy, CDR= correct detection rate, CT= computed tomography, DR= 
detection rate, PET= positron emission tomography, PPV= positive predictive value, PSA= prostate-specific antigen. 
 
 

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1 INVESTIGATIONAL TEAM 
Refer to the trial specific contact list for details of investigators, sponsor personnel, clinical 
research organisation personnel and facilities used in the study. 
 
 

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2 INTRODUCTION 
This study will be conducted in compliance with the protocol, Good Clinical Practice (GCP), 
applicable regulatory requirements, and International Conference on Harmonisation (ICH) 
guidelines. 
2.1 Background 
Prostate cancer (PC) is the second most frequent malignancy in men1. The American Cancer 
Society estimates 248,530 new cases of PC were diagnosed in the United States of America 
(USA) in 2021 accounting for approximately 25% of all new estimated cancer cases in men 
and approximately 13% of all new estimated cancer cases2,3. The incidence of PC correlates 
with age, running between 30% for patients 40-50 years old to 50-80% for patients aged 80 
and over4. Median age at diagnosis is 67 years and median age at death is 81 years5,6. Although 
the etiology of the disease is unclear, the main risk factors include advanced age, ethnicity, and 
positive family history7. While some patients with PC have indolent disease, where the 
patient’s serum prostate-specific antigen (PSA) values are followed without further treatment, 
the majority of patients will receive some treatment for their PC. Between 20-40% of patients 
with PC will relapse within 10 years of their primary PC treatment, as identified through rising 
PSA levels. At relapse, approximately 25-35% of patients have locally recurrent disease, 20-
25% have metastatic disease, and 45-55% have both local and metastatic disease8. As disease 
extent determines the treatment, accurate staging and re-staging particularly in early 
biochemical recurrence are imperative for optimizing treatment regimes. 
Gastrin Releasing Peptide Receptor (GRPR) is a transmembrane G-protein coupled receptor 
that has various physiological functions in the gastrointestinal tract and nervous system9. Its 
pharmacological activities, through binding of its ligand Gastrin Releasing Peptide (GRP), 
include the stimulation of hormone releasing, like gastrin and somatostatin, as well as stomach 
and intestine smooth muscle contraction. Gastrin Releasing Peptide Receptor expression is 
upregulated in many human cancers10, including PC11,12 and breast cancer13, with its normal 
biodistribution mainly concentrated in the pancreas and gastrointestinal tract. Although the 
correlation between GRPR expression and clinical features in PC, such as Gleason score, stage 
of disease and PSA levels, have been evaluated, the results remain inconclusive10. Indeed, a 
recent study showed uptake of a gallium-68-labeled GRPR targeting agent (68Ga-RM2) across 
all PSA levels in biochemical recurrent PC14. 
The Sponsor is developing a radiolabeled antagonist of GRPR for the diagnosis and 
management of PC. The product is copper-64-labeled MeCOSar-PEG4-D-Phe-Gln-Trp-Ala-
Val-Gly-His-Sta-Leu-NH2 (64Cu-SAR-BBN). 64Cu-SAR-BBN uses a radioactive form 
(radionuclide) of copper, Copper-64 (64Cu) to image cancers using Positron Emission 
Tomography (PET).  
The target population for this study is patients with biochemical recurrence of PC following 
initial definitive therapy. Although PSA is the primary biomarker for recurrence, it does not 
reflect the location or the extent of disease recurrence. Despite recent advances in imaging 
techniques, some patients will fail to have their recurrence accurately localized by imaging, 
especially at low PSA levels. Identifying tumor relapses and metastases is challenging for 
conventional imaging modalities such as Computed Tomography (CT) and Magnetic 
Resonance Imaging (MRI) due to limitations in sensitivity and specificity. Early diagnosis of 
recurrence and accurate staging are essential to inform the best treatment strategy. Prostate 
Specific Membrane Antigen (PSMA)-targeting PET agents have been shown to have superior 
sensitivity and specificity compared to conventional imaging, with frequent identification of 

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sub-centimeter PC lesions. Although a PSMA-targeting PET scans is effective for imaging 
disease in the prostate, lymph nodes, soft tissue, and bone in a single examination15, the 
overexpression of PSMA in PC is not universal and 21% of biochemical recurrent PC patients 
were found to have no lesions with characteristics of recurrent PC detected on their PSMA 
PET scan16. Studies comparing GRPR- and PSMA-targeting PET highlighted a distinct 
distribution of the two targets in biochemically recurrent PC14,17, suggesting GRPR-targeting 
PET may add diagnostic value in PSMA-negative PC patients. 
Refer to the Investigator’s Brochure (IB) for detailed information on 64Cu-SAR-BBN. 
2.2 Imaging of Prostate Cancer 
Conventional imaging modalities such as MRI, CT, and 99mTc-methylene diphosphonate 
(99mTc-MDP) bone scan, suffer from limited sensitivity and specificity, which can result in 
inaccurate disease staging leading to suboptimal treatment. The use of molecular imaging using 
PET has therefore been explored to better identify sites of disease. A number of new PET 
diagnostic radiopharmaceuticals have emerged in recent years, including agents that 
accumulate on the basis of alterations in cellular metabolism as well as those that bind to 
specific proteins, such as PSMA18.  
Approved diagnostic radiopharmaceuticals that are commonly used to image PC include 99mTc-
MDP bone scan, 18F-fluorodeoxyglucose (18F-FDG), 18F-sodium fluoride (18F-NaF), 11C-
choline, 18F-FACBC (or 18F-fluciclovine; registered as Axumin®), and more recently, PSMA-
based PET radiopharmaceuticals, 
68Ga-PSMA-11 and 
18F-DCFPyL (registered as 
PYLARIFY®)18,19.  
Currently, 99mTc-MDP planar whole-body scanning is the imaging standard for detection of 
osseous metastases. The 18F-NaF uptake mechanism in the bone is similar to that for 99mTc-
MDP but with better sensitivity and specificity in the detection of bone metastases. These scans 
are both lacking in specificity however, with uptake in areas of bone remodeling such as 
infection and trauma, in addition to osseous metastases. Furthermore, they are limited in the 
detection of soft-tissue malignancies, including the primary tumor, lymph node disease, and 
visceral metastases. 
Although molecular imaging in oncology is most commonly performed with 18F-FDG PET, 
this test has not shown clinical utility in PC imaging20. PC cells typically do not undergo 
increased aerobic glycolysis, limiting the use of 18F-FDG. These cells do, however, display 
upregulated de novo lipid synthesis and activity of lipogenic enzymes. This enables lipid 
precursors such as choline to function as radiotracers for PET imaging in PC. 11C-choline was 
approved by the Food and Drug Administration (FDA) in 2012, but choline-based radiotracers 
are not cancer specific, and can be taken up in other tissues or areas of benign inflammation. 
In addition, its use is affected by the short half-life (t1/2=20 minutes). In studies comparing 11C-
choline to 68Ga-PSMA-11, 68Ga-PSMA-11 showed a higher detection rate than 11C-choline 
PET for lymph nodes as well as bone lesions21,22. 18F-FACBC targets multiple sodium-
dependent and independent channels which are upregulated in PC. 18F-FACBC is a synthetic 
amino acid that is well tolerated and able to detect local and distant PC recurrences across a 
wide range of PSA values23. However, like 11C-choline, 18F-FACBC was shown to be inferior 
to 68Ga-PSMA-11 in prospective imaging trials24.  
Prostate specific membrane antigen has been studied extensively as an imaging target in PC. 
The first commercialized PSMA targeting imaging agent was 111In-labeled-capromab-
pendetide (ProstaScint®), which was approved by the FDA in 1996. However, ProstaScint® 
was only able to bind to the intracellular epitope of PSMA and was therefore not capable of 

Investigational Product: 64Cu-SAR-BBN  
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Protocol: CLB03  
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The aim of the study is to evaluate the safety, pharmacokinetics, and efficacy of 64Cu-SAR-
BBN. The collection of standard safety parameters used in this study such as adverse event 
(AE) reporting, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments are 
considered appropriate for monitoring the health and well-being of participants in early phase 
clinical studies. The biodistribution assessments were selected to characterize the 
pharmacokinetics of 64Cu-SAR-BBN in humans. The assessments performed in this study to 
evaluate diagnostic efficacy are widely used and considered appropriate for the evaluation of 
performance of diagnostic imaging agents.  
This study will provide the Sponsor with information on the safety, pharmacokinetics and 
diagnostic performance of 64Cu-SAR-BBN in the target population, prior to initiating more 
extensive Phase 3 studies. 
2.5.1 Imaging Timepoint Selection 
The 64Cu diagnostic radionuclide has a t½ of 12.7 hours which allows for the completion of 
PET scans up to at least 24 hours post administration of the radiopharmaceutical.  
Preclinical studies with PET/CT images captured at 1, 4 and 24 hours post administration of 
64Cu-SAR-BBN showed that the tumor is clearly visible at the 1 hour timepoint. The tumor-
to-background ratio at 4 and 24 hours was much higher than at 1 hour, demonstrating a high 
degree of accumulation and retention33.  
For this study, a PET/CT scan completed between 1 and 4 hours post dose of 64Cu-SAR-BBN 
(Day 0 scan) is considered to be clinically practical and suitable to assess whether 64Cu-SAR-
BBN is capable of detecting PC in humans. Imaging at 24 hours post dose (Day 1 scan) will 
also be completed as it is hypothesized that delayed imaging may enable the detection of 
smaller lesions due to enhanced tumor-to-background ratios following biological clearance of 
the product over time. 
2.5.2 Dose Selection of 64Cu-SAR-BBN 
64Cu-SAR-BBN will be administered at a fixed administered activity of 200 MBq.  
64Cu-SAR-BBN dosimetry has been calculated from the Investigator-led study in female 
patients with breast cancer and demonstrated that a diagnostic administered activity (200 MBq) 
of 64Cu-SAR-BBN can be used safely with only a low radiation burden to the patient.  Overall, 
the whole-body effective dose was estimated to be 0.0095 mSv/MBq or 1.9 mSv for a 200 
MBq injection of 64Cu-SAR-BBN. An effective dose of this magnitude is comparable and 
below the risks associated with other routinely used imaging agents such as 18F-FDG (8.4 mSv 
according to the Nuclear Medicine Radiation Dose Tool - SNMMI), and the recently approved 
68Ga-PSMA-11 and 18F-DCFPyL at their recommended administered activity (4.4 mSv and 3.9 
mSv, respectively, according to approved labeling). The clinical biodistribution study projected 
that the pancreas was the organ with the highest absorbed dose, but with good clearance over 
24 hours. A 200 MBq administered activity of 64Cu-SAR-BBN will limit the estimated 
radiation absorbed dose to the pancreas to approximately 38.8 mGy, while the absorbed dose 
to the kidneys and bone marrow would be approximately 7.2 mGy and 2.6 mGy, respectively.  
Based on the data obtained to date in the C-BOBCAT study, the Sponsor believes that 
200 MBq of 64Cu-SAR-BBN is an adequate activity to guarantee sufficient image quality for 
this study across the selected imaging timepoints. 

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2.6 Benefit/Risk Assessment 
It is not known if study participants will gain any improvement in their own healthcare 
outcomes as a result of their participation in this study. However, the ability to accurately 
identify and stage PC recurrence would enable more effective treatment decisions and this 
would therefore, be considered a benefit to the participant. A general societal benefit is widely 
considered to accrue from medical scientific knowledge accumulated through the conduct of 
ethical research on participants. 
All study participants will receive a single administration of 64Cu-SAR-BBN. Specific 
foreseeable risks to study participants include:  
• Radiation dose received by the study participant: A first-in-human study of 64Cu-SAR-
BBN in seven female participants with breast cancer estimated that an administration 
of 200 MBq of 64Cu-SAR-BBN would result in an effective whole-body dose of 
1.9 mSv, which is comparable to the whole-body effective doses of other routinely used 
imaging agents at their recommended administered activity. There is a potential hazard 
from the additional radiation burden to study participants. The study also involves low 
dose CT scan(s) performed for attenuation correction of the PET scan(s) and for the 
anatomical correlation to allow more precise delineation of organs. 
• Chemical toxicity of 64Cu-SAR-BBN and other constituents of the injection: The 
constituents (including excipients and stabilizers) of 
64Cu-SAR-BBN are at 
concentrations that are known to be safe for human use. 64Cu-SAR-BBN, as supplied, 
will result in a maximum quantity not exceeding 100 μg of peptide mass per participant 
for an administration. The administered peptide mass is therefore at least 96 times less 
than the dose of Cu-SAR-BBN that has been demonstrated to be without any relevant 
toxicity in rodent toxicology studies (based on a 60 kg subject). The administered dose 
is well below the limits specified by the FDA for microdosing studies. 
• Intravenous administration: Minor pain may occur at the time of venipuncture and 
minor bruising may also result; however, patients are exposed to these same risks 
during routine care. Whilst extravasation of PET radiopharmaceuticals is possible, it is 
unlikely associated with adverse outcomes due to the very small mass of materials 
contained in the injection, and the small amount of radioactivity available for injection. 
Nevertheless, an indwelling canula can be established prior to investigational product 
administration to mitigate this risk. 
• Incidental findings of possible clinical significance: Appropriate diagnostic testing can 
assist in making a correct diagnosis and in providing additional information to guide 
patient management. An incorrect diagnosis (e.g., false negative or false positive results 
of the diagnostic tests) can have important consequences in patient management. An 
incidental finding is an imaging finding of potential health importance concerning the 
study participant, which is discovered while conducting imaging research, but is 
beyond the aims of the study. It is the responsibility of the local site or of the study 
Investigator to arrange for routine clinical review of study scans and clinical follow-up, 
as required. Policies for the communication of the incidental finding to the research 
participant should align with national regulations and customs. As part of the informed 
consent process, research participants will be informed about the possibility that 
incidental imaging findings may be detected, and about the pathway for handling such 
findings.  
 
 

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3 STUDY OBJECTIVES AND ENDPOINTS 
3.1 Primary Objectives and Endpoints 
The primary study objectives and endpoints to be evaluated in this study are presented in Table 
1. 
Table 1 Primary Study Objectives and Endpoints 
Objective 
Endpoint 
To investigate the safety and 
tolerability of 64Cu-SAR-BBN. 
Incidence and severity of treatment-emergent AEs and 
SAEs following the administration of 64Cu-SAR-BBN. 
To investigate the ability of 64Cu-
SAR-BBN PET/CT to correctly 
detect recurrence of PC. 
• 
Participant-level CDR, defined as the proportion of TP 
participants on the Day 0 scan out of all participants 
with a Day 0 scan. 
• 
Participant-level CDR, defined as the proportion of TP 
participants on the Day 1 scan out of all participants 
with a Day 1 scan. 
• 
Region-level PPV, defined as the proportion of TP 
regions on the Day 0 scan out of all positive regions on 
the Day 0 scan. 
• 
Region-level PPV, defined as the proportion of TP 
regions on the Day 1 scan out of all positive regions on 
the Day 1 scan. 
Abbreviations: AE = adverse event; CDR = correct detection rate; CT = computed tomography; PET = positron 
emission tomography; PC = prostate cancer; PPV = positive predictive value; SAE = serious adverse event; TP = 
true positive 
3.2 Secondary Objectives and Endpoints 
The secondary study objectives and endpoints to be evaluated in this study are presented in 
Table 2. 
Table 2 Secondary Study Objectives and Endpoints 
Objective 
Endpoint 
To investigate the biodistribution of 
64Cu-SAR-BBN. 
Biodistribution of 64Cu-SAR-BBN on the Day 0 and Day 1 
scan:  
• 
Maximum and mean SUVs in lesion(s), visceral/soft 
tissue, bone. 
• 
Lesion-to-background ratio. 
To assess the participant-level PPV 
of 64Cu-SAR-BBN PET/CT.  
• 
Participant-level PPV, defined as the proportion of TP 
participants on the Day 0 scan out of all participants 
with a positive Day 0 scan. 
• 
Participant-level PPV, defined as the proportion of TP 
participants on the Day 1 scan out of all participants 
with a positive Day 1 scan. 

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To assess the participant-level DR of 
64Cu-SAR-BBN PET/CT.  
• 
Participant-level DR, defined as the proportion of 
participants with a positive Day 0 scan out of all 
participants with a Day 0 scan. 
• 
Participant-level DR, defined as the proportion of 
participants with a positive Day 1 scan out of all 
participants with a Day 1 scan. 
To assess the FPR 64Cu-SAR-BBN 
PET/CT. 
• 
Participant-level FPR, defined as the proportion of FP 
participants on the Day 0 scan out of all participants 
with a positive Day 0 scan. 
• 
Participant-level FPR, defined as the proportion of FP 
participants on the Day 1 scan out of all participants 
with a positive Day 1 scan. 
• 
Region-level FPR, defined as the proportion of FP 
regions on the Day 0 scan out of all positive regions on 
the Day 0 scan. 
• 
Region-level FPR, defined as the proportion of FP 
regions on the Day 1 scan out of all positive regions on 
the Day 1 scan. 
To 
assess 
the 
discrepant 
PET 
negativity rate of the 64Cu-SAR-BBN 
PET/CT scans. 
Participant-level discrepant PET negativity rate, defined as 
the proportion of participants with contradicting Day 0 and 
Day 1 results for whom the Reference Standard was 
positive. 
To assess the TNR of 64Cu-SAR-BBN 
PET/CT. 
• 
Participant-level TNR, defined as the proportion of TN 
participants on the Day 0 scan out of all participants 
with a negative Day 0 scan. 
• 
Participant-level TNR, defined as the proportion of TN 
participants on the Day 1 scan out of all participants 
with a negative Day 1 scan. 
• 
Region-level TNR, defined as the proportion of TN 
regions on the Day 0 scan out of all negative regions on 
the Day 0 scan. 
• 
Region-level TNR, defined as the proportion of TN 
regions on the Day 1 scan out of all negative regions on 
the Day 1 scan. 
Abbreviations: CT= computed tomography; DR= detection rate; FP= false positive; FPR= rate of false positive; 
PET= positron emission tomography; PPV= positive predictive value; SUV= standardized uptake value; TN= true 
negative; TNR= rate of true negative; TP= true positive 
3.3 Exploratory Objectives and Endpoints 
The exploratory study objectives and endpoints to be evaluated in this study are presented in 
Table 3. 
 
 

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Table 3 Exploratory Study Objectives and Endpoints 
Objective 
Endpoint 
To evaluate the reproducibility of the 
64Cu-SAR-BBN PET/CT readings 
and consistency among readers. 
• 
Intra-reader variability per reader. 
• 
Inter-reader variability expressed by kappa statistics. 
To assess the impact of 64Cu-SAR-
BBN 
PET/CT 
on 
disease 
management. 
Proportion of participants with any change in intended PC 
treatment due to either the Day 0 or Day 1 scan. 
Composite performance of the Day 0 
and Day 1 64Cu-SAR-BBN PET/CT 
scans. 
• 
Composite CDR defined as the proportion of TP 
participants on the Day 0 and/or Day 1 scan out of all 
participants with a Day 0 and/or Day 1 scan. 
• 
Composite participant/region-level PPV defined as the 
proportion of TP participants/regions on the Day 0 
and/or Day 1 scan out of all participants/regions with a 
positive Day 0 and/or Day 1 scan.  
• 
Composite DR defined as the proportion of participants 
with a positive Day 0 and/or Day 1 scan out of all 
participants with a Day 0 and/or Day 1 scan. 
To determine the effect of baseline 
variables on the CDR, PPV and DR of 
64Cu-SAR-BBN PET/CT. 
CDR, participant- and region-level PPV and DR of the Day 
0 and/or Day 1 scan as a function of baseline variables. 
 To explore the correlation between 
64Cu-SAR-BBN PET-positivity and 
Reference Standard results. 
Relationship 
between 
PET-positivity 
(biodistribution 
measures such as SUVs and lesion-to-background ratio), 
versus true/false positivity and as a function of lesion 
location and size. 
To 
assess 
the 
lesion-level 
performance 
of 
64Cu-SAR-BBN 
PET/CT. 
• 
Difference in the number of lesions detected per 
participant on the Day 0 versus the Day 1 scan. 
• 
Overall agreement rate on the Day 0 and Day 1 scans, 
defined as the number lesions with matching subregion 
divided by the total number of lesions identified across 
all scans by either imaging.  
• 
Overall agreement rate on the Day 0 and reference 
scans, defined as the number lesions with matching 
subregion divided by the total number of lesions 
identified across all scans by either imaging. 
• 
Overall agreement rate on the Day 1 and reference 
scans, defined as the number lesions with matching 
subregion divided by the total number of lesions 
identified across all scans by either imaging. 
Abbreviations: CDR= correct detection rate; CT= computed tomography; DR= detection rate; PC= prostate 
cancer; PET= positron emission tomography; PPV= positive predictive value; TP = true positive 

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4 STUDY DESIGN 
4.1 Study Overview 
Approximately 50 participants are planned to be enrolled in this study. This is a multi-center, 
single arm, non-randomized, open-label study of 64Cu-SAR-BBN administered to participants 
with biochemical recurrence of PC following definitive therapy. To be considered for inclusion 
in the study, candidates must demonstrate negative or equivocal findings for PC on approved 
PSMA (68Ga-PSMA-11 or 18F-DCFPyL) PET and anatomical imaging (CT and/or MRI) and 
other conventional imaging, if available.  
Participants who provide informed consent will undertake screening visit(s) to determine their 
eligibility to participate in the study. The maximum Screening period for each participant is 28 
days. After the Screening period, eligible participants will receive a single administration of 
64Cu-SAR-BBN on Day 0, followed by a PET/CT scan at 1 to 4 hours post dose (Day 0 scan) 
and at 24 hours post dose (Day 1 scan). Safety of 64Cu-SAR-BBN will be assessed post dose 
on Day 0, Day 1, and Day 7. Participants will then continue into the maximum 180-day Follow-
Up period to verify the 64Cu-SAR-BBN PET/CT findings by:  
• Follow-up conventional imaging: All participants will undergo conventional imaging 
at 90 days ± 15 days post Day 0.  
o Participants who are deemed to be negative or equivocal for PC recurrence 
based on central review of the 90-day conventional imaging will undergo 
further conventional imaging at 180 days ± 15 days post Day 0.  
o Participants who are deemed positive for PC recurrence based on central review 
of the 90-day conventional imaging will require no further study visits. 
However, if additional follow-up imaging per Investigator discretion is acquired 
within 180 days post Day 0, these data must be provided to the central reading 
center.  
• Histopathology: Where feasible, obtaining histopathology from biopsy or surgery 
should be attempted for as many 64Cu-SAR-BBN PET-positive lesions as possible 
(based on the local interpretation of the 64Cu-SAR-BBN PET/CT scans) within 180 
days of Day 0. If clinically feasible, the Investigator should make every effort to obtain 
histopathology for at least one 64Cu-SAR-BBN PET-positive lesion per region. 
• Assessment of PSA levels: PSA will be assessed in all participants at 90 days ± 15 
days and if the participant is returning to the study site for further follow-up imaging, 
at 180 days ± 15 days post Day 0. If radiation therapy or other salvage focal therapy 
(e.g., cryotherapy) is initiated during the study (as long as no concomitant androgen-
deprivation therapy [ADT] is given), PSA levels must be monitored every 4 weeks from 
the initiation of the therapy. Prostate specific antigen response (defined as total PSA 
decline by ≥50% from baseline) must be confirmed by a second value within 4 weeks. 
Central Review of Scans: The 64Cu-SAR-BBN PET/CT scans will be interpreted by an 
appropriately qualified local Investigator and three independent, blinded, central readers. Each 
reader will be required to evaluate the PET/CT scans individually for the presence of 
pathological 64Cu-SAR-BBN uptake in the prostate bed/gland, pelvic lymph nodes, extra pelvic 
lymph nodes, visceral/soft tissue and bone.  
Expert Panel Composite Reference Standard: The 64Cu-SAR-BBN PET/CT findings will be 
assessed against a composite Reference Standard. The composite Reference Standard will be 

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determined by an independent, blinded, central expert panel and may consist of histopathology, 
conventional imaging modalities that are routinely used in the diagnosis and staging of PC and 
PSA levels. The Investigator will be required to submit all relevant clinical evidence available 
for the participant to enable the assessment of the Reference Standard. The expert panel will 
determine the composite Reference Standard without knowledge of the 64Cu-SAR-BBN 
PET/CT results. 
To assess the impact of 64Cu-SAR-BBN PET/CT on disease management, the treating 
physician will be required to fill out a Pre-SAR-BBN and a Post-SAR-BBN Disease 
Management Form to provide information on the treatment strategy of the participant before 
and after the information from the local read of the 64Cu-SAR-BBN PET/CT scan(s) becomes 
available. 
 
Figure 1 Overall Study Design 
Screening 
(Visit 1: 
28 days) 
→ 
 
64Cu-SAR-BBN PET/CT 
(Visit 2-3: Day 0 and Day 1) 
→ 
Safety Visit 
(Visit 4: Day 
7 ±2 days) 
→ 
Follow-Up 
(Visit 5-6: Day 90 and 180* 
±15 days) 
 
 
 
 
 
 
 
 
 
• 
Single 64Cu-SAR-BBN 
dose on Day 0 
• 
PET/CT at 1-4 h and 24 
(±6) h post 64Cu-SAR-
BBN administration 
 
 
 
• 
Conventional imaging 
• 
Histopathology for 
64Cu-SAR-BBN PET-
positive lesions  
• 
PSA  
 
*Day 180 visit is only applicable for participants who were deemed negative or equivocal for PC recurrence at 
Day 90. 
Abbreviations: CT=computed tomography; h= hour; PET= positron emission tomography; PSA=prostate specific 
antigen 
4.2 Study Duration, Beginning and End of Study 
Participants are considered enrolled in the study once they are appropriately consented and 
screened, with eligibility verified by an Investigator.  
The total duration of the study is ~13 months.  
The expected study recruitment period is ~6 months. 
The maximum screening period for each participant is ~28 days. 
The maximum on study period for each participant is ~6 months.  
The end of study is defined as the date of the final participant visit/contact. In addition, Clarity 
may decide to terminate the study at any time (see Section 5.5). 
 
 

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5 STUDY ENROLLMENT AND WITHDRAWAL 
5.1 Study Population 
The target study population is patients with biochemical recurrence of PC following definitive 
therapy and negative or equivocal findings for PC on approved PSMA PET and anatomical 
imaging (CT and/or MRI), and other conventional imaging, if available. The inclusion and 
exclusion criteria are outlined below.  
5.1.1 Inclusion Criteria  
Study candidates must meet all the following criteria to be eligible for the study: 
1. At least 18 years of age. 
2. Signed informed consent. 
3. Life expectancy ≥ 12 weeks as determined by the Investigator. 
4. Histologically confirmed adenocarcinoma of prostate per original diagnosis and 
completed subsequent definitive therapy. 
5. Suspected recurrence of PC based on rising PSA after definitive therapy on the basis 
of: 
a. Post-radical prostatectomy: detectable or rising PSA that is ≥ 0.2 ng/mL with a 
confirmatory PSA ≥ 0.2 ng/mL (per American Urological Association 
recommendation); or 
b. Post-radiation therapy, cryotherapy, or brachytherapy: increase in PSA level 
that is elevated by ≥ 2 ng/mL above the nadir (per American Society for 
Therapeutic Radiology and Oncology-Phoenix consensus definition). 
6. Negative or equivocal findings for PC on (1) approved PSMA PET and (2) 
anatomical imaging (CT and/or MRI), and (3) if available, any other conventional 
imaging performed as part of routine standard of care (SOC) imaging workup within 
60 days prior to Day 0.  
7. The Eastern Cooperative Oncology Group (ECOG) performance status 0-2.  
8. Adequate recovery from acute toxic effects of any prior therapy.  
9. Estimated Glomerular Filtration Rate (eGFR) of 30 mL/min or higher.  
10. Adequate liver function defined as alanine aminotransferase/aspartate 
aminotransferase <3 x upper limit of normal (ULN) and total bilirubin <1.5 x ULN 
(except in the case of Gilbert’s syndrome). 
11. For participants who have partners of childbearing potential: Partner and/or 
participant must use a method of birth control with adequate barrier protection. 
5.1.2 Exclusion Criteria  
Study candidates who meet any of the following criteria are not to be enrolled in the study: 
1. Participants who received other investigational agents within 28 days prior to Day 0. 
2. Participants administered any high energy (>300 KeV) gamma-emitting radioisotope 
within 5 physical half-lives prior to Day 0.  

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3. Ongoing treatment or treatment within 90 days of Day 0 with any systemic therapy 
(e.g., ADT, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-
releasing hormone agonist or antagonist) for PC. 
4. Participants who are known to require prohibited treatment (e.g., initiation of ADT due 
to rapidly rising PSA) before the 64Cu-SAR-BBN PET/CT results can be verified via 
histopathology or follow-up imaging. 
5. Known or expected hypersensitivity to 64Cu-SAR-BBN or any of its components. 
6. Any serious medical condition or extenuating circumstance which the Investigator 
feels may interfere with the procedures or evaluations of the study. 
5.2 Enrollment and Method of Assigning Participants to Treatment 
Groups 
This is a non-randomized, single-arm study. After completing the screening period, participants 
who meet all eligibility criteria, will be enrolled into the study and receive a single 
administration of 64Cu-SAR-BBN.  
Each participant will be identified in the study by a Participant Number that is assigned when 
the participant is first entered into screening and is retained as the primary identifier for the 
participant throughout his entire participation in the trial. The Participant Number consists of 
the Center Number (as assigned by Clarity to the investigative site) with a sequential participant 
number suffixed to it, so that each participant is numbered uniquely across the entire database. 
Upon signing the informed consent form, the participant is assigned to the next sequential 
Participant Number available to the Investigator. 
5.3 Study Blinding 
This is a single-arm, open label study. All participants will receive 64Cu-SAR-BBN and thus 
blinding of the investigational product is not applicable. 
However, to allow for a non-biased assessment of the 64Cu-SAR-BBN PET/CT, the scans will 
be assessed by three independent central readers, blinded to the participants-specific 
information (identifiers, medical history, physical exam, laboratory results), the timepoint of 
the scan, results of evaluations as part of the Reference Standard, results of other imaging 
modalities, final diagnosis / outcome, and details of the protocol. 
To allow for a non-biased assessment of the Reference Standard, an independent central panel 
of experts will be used to assess and determine the composite Reference Standard. The expert 
panel will not include any of the three readers who assess the 64Cu-SAR-BBN PET/CT scans. 
The panel will not have access to the 64Cu-SAR-BBN PET/CT scans or reports from the local 
or central read of the scans. 
5.4 Participant Withdrawal and Replacement 
5.4.1 Screening Failures and Rescreening 
5.4.1.1 Screen Failures 
Screen failures are those participants who do not meet the study eligibility criteria. For 
participants who are considered a screen failure, the reason for screen failure will be entered 
on the Screening Log. The demographic information, informed consent, and 
inclusion/exclusion pages must also be completed for screen failure participants. If the 

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participant experiences a serious adverse event (SAE) during the screening period, this 
information must also be entered (see Section 10.3 for SAE reporting details).  
5.4.1.2 
Rescreening 
Participants who fail screening assessments may be re-screened. Rescreening and specific 
assessments to be repeated is to be discussed on a case-by-case basis with the Medical Monitor.  
Rescreened participants should be assigned the same participant number as for the initial 
screening, which is deemed appropriate and practical from a reporting perspective. Participants 
may only participate in the study once.  
5.4.2 Withdrawal of Consent and Discontinuation of Participants from the Study 
Participants will be informed that they have the right to withdraw consent or discontinue from 
the study at any time for any reason, without prejudice to their medical care.  
Following enrolment into the study, if a participant is discontinued or withdraws consent for 
any reason, whether related to the investigational product or not, the participant will be 
considered an early-discontinued participant. The reason for study discontinuation or 
withdrawal of consent is to be documented in the participants’ source documents and electronic 
case report form (eCRF).  
Refer to Section 5.4.2.1  for individual stopping rules. 
1. Withdraw of Consent to Participate in the Study 
Withdrawal of consent occurs only when a participant (or their substitute decision 
maker/person responsible) does not want to participate in the study any longer, does not want 
any further study related visits or assessments and does not want any further study related 
contact. The Sponsor will continue to retain and use all research results that have already been 
collected for the study evaluation up until the point of withdrawal of consent. All biological 
samples that have already been collected may be retained and analyzed at a later date (or as 
required by local regulations).  
If a participant withdraws consent, the Investigator should make an effort to determine the 
primary reason for this decision (however the participant is not required to provide a reason) 
and record this information along with the withdrawal of consent discussion, which should be 
documented in the patient notes. With the participants consent, the Investigator may perform 
some final safety evaluations to ensure that there are no safety risks associated with the 
participants withdrawal. Further attempts to contact the participant for study related discussions 
are not allowed unless safety findings require communication or follow-up. 
2. Investigator Decision to Discontinue the Participant 
The Investigator also has the right to discontinue participants from the study for any of the 
following reasons: 
• Participant non-adherence to protocol requirements; 
• Any other reason based upon the medical judgment of the Investigator.  
 
The Investigator will make every effort to ensure that early-discontinued participants who have 
received investigational product complete safety follow-up assessments (refer to Schedule of 
Assessments).  
3. Lost to follow-up 

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Reasonable efforts will be made to keep in contact with enrolled study participants. Participants 
who have not responded to at least 3 such attempts for follow-up may be deemed ‘lost to 
follow-up’. Efforts made to contact study participants must be documented in the participant’s 
file. 
5.4.2.1 Individual Stopping Rules 
No individual stopping rules apply as only a single 64Cu-SAR-BBN administration is delivered 
in the study. 
5.4.3 Pregnancy 
There is no information about the effects that 64Cu-SAR-BBN could have on the development 
of the fetus in humans. Therefore, it is important that female partners of sexually active 
participants, do not become pregnant during the study and agree to use adequate contraception. 
Participants will be instructed that known or suspected pregnancy occurring during the study 
in female partners, should be confirmed and reported to the Investigator. 
The Investigator should also be notified of a pregnancy of a female partner of the participant 
occurring during the study. In the event that a female partner of a participant is found to be 
pregnant whilst the participant is enrolled in the study, the pregnancy will be followed, and the 
status of mother and child will be reported to the Sponsor (or delegate). 
A Pregnancy Report Form will be completed and submitted for any pregnancy occurring in 
female partners of male participants from enrollment until study completion. 
5.4.3.1 Acceptable Forms of Contraception 
Sexually active participants with female partners of childbearing potential are eligible to 
participate if they agree to follow 1 of the following methods of contraception consistently, 
starting from Screening, and for at least 5 days after the administration of 64Cu-SAR-BBN: 
• Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle 
(abstinent on a long-term and persistent basis) and agree to remain abstinent; 
• Are sterilized (with the appropriate post-vasectomy documentation of the absence of 
sperm in the ejaculate); 
• Agree to use a male condom and have their partner use a contraceptive method with a 
failure rate of <1% per year as described below when having penile-vaginal 
intercourse with a woman of childbearing potential who is not currently pregnant, and 
who agrees to the use of a condom by her partner. 
Sexually active male participants with a pregnant or breastfeeding partner must agree to remain 
abstinent from penile‑vaginal intercourse; or use a male condom during each episode of penile 
penetration from Screening, and for at least 5 days after the administration of 64Cu-SAR-BBN. 
A highly effective method of contraception/birth control method which result in low failure 
rate (i.e., less than 1% per year when used consistently and correctly) must be used starting 
from the screening visit and for at least 5 days after the administration of 64Cu-SAR-BBN. 
Examples of acceptable contraception include: 
• Established use of oral, injected or implanted hormonal methods of contraception; 
• Placement of an intrauterine device or intrauterine system; 
Examples of non-acceptable methods of contraception include: 

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• Condoms alone or double barrier; 
• Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation); 
• Withdrawal; 
• 
Spermicide. 
5.4.3.2 Sperm Donation 
Participants must refrain from donating sperm starting from Screening, during the study and 
for at least 5 days after the administration of 64Cu-SAR-BBN.  
5.4.4 Replacement of Participants 
Participants who do not complete all required study visits (including those who receive 
prohibited treatment and are discontinued early) may be replaced if needed to achieve the target 
sample size. Participants who withdraw prior to receiving investigational product will be 
replaced. 
5.5 Premature Termination or Suspension of Study 
The study can be temporarily suspended or prematurely terminated at any time for any reason 
by Clarity if there is sufficient reasonable cause. Written notification, documenting the reason 
for study suspension or termination, will be provided by the suspending or terminating party 
to the Investigator, and regulatory authorities.  
Should this be necessary, the participants should be seen as soon as possible to perform the 
Safety Visit. Participants in long-term follow-up should also be contacted for a final visit. The 
Investigator may be informed of additional procedures to be followed in order to ensure that 
adequate consideration is given to the protection of the participant’s interests. 
If the study is prematurely terminated or suspended, the Investigator will be responsible for 
promptly informing the institutional review board (IRB) and will provide the reason(s) for the 
termination or suspension.  
Circumstances that may warrant termination or suspension include, but are not limited to:  
• Determination of unexpected, significant, or unacceptable risk to participants; 
• Demonstration of efficacy that would warrant stopping; 
• Insufficient compliance to protocol requirements; 
• Data that are not sufficiently complete and/or evaluable; 
• Sponsor terminates the study for administrative, financial or other reasons. 
5.6 Safety Review Committee 
A Safety Review Committee is not deemed necessary for this study based on what is known 
regarding the safety of 64Cu from other studies. The medical monitor will periodically review 
laboratory and AE data and will review SAE reports in real time. Any clinically important 
findings will be discussed with the Investigators. 
 
 

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6 INVESTIGATIONAL PRODUCT 
6.1 Dosage and Formulation 
The investigational product administered in this study is 64Cu-SAR-BBN. Clarity is developing 
this radiopharmaceutical for the diagnosis and management of GRPR-positive tumors. 
64Cu-SAR-BBN has 3 basic components; the radionuclide (64Cu), bound via MeCOSar (a 
bifunctional metal chelator) to an antagonist that targets GRPR. 
64Cu-SAR-BBN will be administered as a bolus IV injection. 64Cu-SAR-BBN will be 
formulated as a sterile solution for IV injection suitable for human use.  
64Cu-SAR-BBN is considered an investigational product by the FDA, and as such will be under 
controlled conditions for use in clinical trials.   
Table 4 Investigational Product Administered 
Investigational 
Product 
Route of 
administration 
Dose (MBq) 
Dose Frequency 
64Cu-SAR-
BBN 
Intravenous Bolus 
Injection 
200 MBq per administration 
Single administration on 
Day 0 
6.2 Supply, Packaging and Labeling 
64Cu-SAR-BBN will be manufactured, packaged, and labeled on behalf of Clarity and will be 
provided with appropriate documentation for human use. 
64Cu-SAR-BBN will be supplied as ready-to-use product according to production and quality 
control methods.  
The release of each final batch of 64Cu-SAR-BBN for human use is subject to the quality 
control measures (product specifications) established by Clarity, with quality control testing 
undertaken by the manufacturing facilities. Available analytical and production data for each 
batch will be reviewed by qualified personnel at the facility to ensure suitability for human 
administration. 
6.3 Storage and Stability 
64Cu-SAR-BBN will be stored in a secure location (i.e., limited access area). 
The Investigator (or suitably qualified designee) agrees not to dispense the 64Cu-SAR-BBN 
from, nor store them at, any site other than the approved study sites as per local regulations. 
Once prepared, 64Cu-SAR-BBN is stored at room temperature in a butyl septum sealed, sterile, 
pyrogen-free glass vial with an expiration date and time designation on the label.  
Refer to the IB for stability information.  
64Cu decays to stable (non-radioactive) daughter products. 
6.4 Dispensing and Administration 
64Cu-SAR-BBN should be received, used, and administered only by suitably qualified persons 
at the study center. The receipt, storage, use, transfer, and disposal of 64Cu-SAR-BBN is subject 
to the regulations and/or appropriate license of the study center.   

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64Cu-SAR-BBN should be handled by the user in a manner which satisfies both radiation safety 
and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken. 
64Cu-SAR-BBN will be administered as a bolus IV injection under the supervision of the study 
Investigator or medically qualified delegate at a dosage of 200 MBq per administration of 64Cu- 
SAR-BBN.  
The Investigator or medically qualified delegate should ensure that the injected radioactivity is 
within ± 10% of prescribed activity. 
6.4.1 Radiation Protection 
64Cu-SAR-BBN is a radiopharmaceutical, therefore it should only be used by personnel who 
are qualified by training and experience in the safe use and handling of radionuclides and whose 
experience and training have been approved by the appropriate governmental agency 
authorized to license the use of radionuclides.  
Radiation protection precautions must be taken in accordance with national and local 
regulations. Full details of restrictions and guidelines to the participant, friends, family and 
caregivers may be described in the informed consent form (ICF) and the IB. 
6.5 Compliance and Accountability 
The Investigator (or designee) is responsible for investigational product accountability, 
reconciliation, and record maintenance at the investigational site. In accordance with all 
applicable regulatory requirements, the Investigator or designated site staff must maintain 
investigational product accountability records throughout the course of the study. The amount 
of investigational products received from the Sponsor, and the amount administered to 
participants, and any amount accidentally or deliberately destroyed will be documented.  
6.5.1 Storage of Supplies 
Study materials will be stored by the study personnel according to the documentation provided 
with the study materials. The Sponsor reserves the right to inspect the investigational product 
storage area before and during the study. 
6.5.2 Control of Supplies 
Dispensing of the investigational products will be carefully recorded on appropriate 
investigational product accountability forms and will be verified by the study monitor during 
monitoring visits. 
The accountability logs should include dates, quantities, batch numbers, and any unique pack 
numbers assigned to the investigational product and/or participant. The accountability logs will 
also include general details related to the study including the protocol, Sponsor and the 
Investigator. 
6.5.3 Destruction of Supplies 
The study monitor will review the investigational product accountability logs which detail the 
destruction of used and unused investigational products by the site.  

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6.6 Investigational Product Administration 
6.6.1 Participant Preparation Prior to Dosing 
There is no need for the participants to fast before the administration of 64Cu-SAR-BBN. 
6.6.2 Selection of Dose of 64Cu-SAR-BBN  
All participants will receive a single IV administration of 200 MBq of 64Cu-SAR-BBN. 
6.7 Participant Release and Radioprotection Precautions 
Release of participants following administration of 64Cu-SAR-BBN will be in accordance with 
any applicable regulations at the study center.  
 
 

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7 CONCOMITANT MEDICATIONS 
Any medication or vaccine (including over the counter or prescription medicines, vitamins, 
and/or herbal supplements) that the participant receives during the study (refer to Schedule of 
Assessments) must be recorded on the eCRF along with: 
• Reason for use; 
• Dates of administration including start and end dates; 
• Dosage information including dose and frequency. 
If the use of any concomitant treatment becomes necessary (e.g., for treatment of an AE), the 
treatment and administration details must be recorded in the source documents and the eCRF.  
The Medical Monitor must be notified of all prohibited medications administered to any 
participant, in order to assess the participant’s eligibility to continue in the study. 
Participants who are known to require prohibited treatment (e.g., initiation of ADT due to 
rapidly rising PSA) before the 64Cu-SAR-BBN PET/CT results can be verified via 
histopathology or follow-up imaging should not be considered for participation in this study. 
7.1 Required Treatments 
Nil. 
7.2 Permitted Treatments 
All SOC treatments are permitted throughout the duration of a participant’s involvement in the 
study with the exception of those treatments outlined in Section 7.3.  
7.3 Prohibited Treatments 
Treatment with investigational agents (that are likely to affect PSA levels or antineoplastic 
agents), 
saw 
palmetto, 
estrogens, 
steroids, 
testosterone 
supplements, 
5ARIs 
(finasteride/dutasteride), and any antineoplastic therapy (with the exception of radiation or 
other salvage focal therapy with no concomitant ADT initiated following completion of Visit 
4) is prohibited throughout the duration of the participant’s involvement in the study.  
Histopathological confirmation of PC prior to commencement of radiation or other 
salvage focal therapy is strongly encouraged.  
Participants who receive prohibited treatment(s) should remain in the study until completion 
of Visit 4 to enable the assessment of safety. 
 
 

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8 STUDY PROCEDURES AND ASSESSMENTS 
The following sections describe the study procedures and assessments to be performed during 
the study. Unplanned visits not specified by the protocol or unscheduled assessments may be 
performed as clinically indicated at discretion of the Investigator; the associated data should 
be recorded on the relevant eCRF in support of an AE diagnosis or tumor assessments.  
Refer to Table 5 for the Schedule of Assessments. 
 
 

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1 Results of SOC tests or examinations performed prior to obtaining informed consent and within 28 days prior to Day 0 may be used; such tests do not need to be repeated for Screening. The required 
conventional scan(s) must be performed within 60 days of Day 0. Conventional scan(s) performed more than 60 days prior to Day 0 may be repeated as a study screening procedure and reviewed by the 
Investigator prior to Day 0. 
2 Visit 6 is only applicable to participants who were deemed negative or equivocal for PC recurrence based on the Visit 5 follow-up conventional imaging (as per the central expert panel’s interpretation). 
3 Informed consent must be documented before any study-specific screening procedure is performed and may be obtained more than 28 days before the 64Cu-SAR-BBN administration. 
4 Demographic data include: year of birth, race, ethnicity. Baseline disease characteristics include: initial diagnosis stage (per American Joint Committee on Cancer), initial Gleason score, initial diagnosis 
stage (T, N and M staging), pathology results, date of biochemical recurrence, relevant symptom history including, gastrointestinal, genitourinary and musculoskeletal. 
5 Medical history will include evaluation of: relevant past or present diseases or disorders, and relevant surgical history. Medication history within 14 days before signing informed consent should be collected. 
6 Physical examination includes assessment of: general appearance, cardiovascular system, respiratory system, and nervous system if vertebral involvement. 
7 ECOG Scale is used by the Investigator to determine the score (0 to 5) that best represents the participants’ activity status. 
8 Vital signs include: body temperature, respiratory rate, heart rate and systolic and diastolic blood pressure. 
9 Post-dose vital signs to be completed prior to the 64Cu-SAR-BBN PET/CT. 
10 Post-dose ECG to be performed at 30 minutes (±10 minutes) post 64Cu-SAR-BBN administration. 
11 Hematology: hemoglobin, hematocrit, red blood cell count, white blood cell count (WBC), platelet count, differential WBC (neutrophils, eosinophils, basophils, lymphocytes, and monocytes), absolute 
neutrophil count, and absolute lymphocyte count. 
12 Biochemistry (pre-prandial): albumin, total protein, blood glucose, sodium, potassium, blood urea nitrogen, creatinine, calcium, uric acid, aspartate aminotransferase, alanine aminotransferase, total 
bilirubin, alkaline phosphatase. 
13 Coagulation: prothrombin time, activated partial thromboplastin time, D-dimer.  
14 Urinalysis to include determination of protein, glucose, nitrites, and leukocytes (dipstick test). 
15 If radiation or other salvage focal therapy is initiated during the study, PSA levels will be monitored independent of the study visit schedule at every 4 weeks (±2 days) from the initiation of the therapy. 
PSA response (defined as total PSA decline by ≥50% from baseline) must be confirmed by a second value within 4 weeks. 
16 PET/CT scan to be performed at 1 to 4 hours post 64Cu-SAR-BBN administration.  
17 PET/CT scan to be performed at 24 hours (±6 hours) post 64Cu-SAR-BBN administration. 
18 Conventional imaging during screening must include an approved PSMA PET (such as 18F-DCFPyL or 68Ga-PSMA-11) and a CT and/or MRI. A diagnostic quality CT completed as part of a PET/CT 
scan is acceptable.   
19 Any other available conventional imaging performed as part of routine SOC imaging workup within 60 days prior to Day 0 is to be reviewed and recorded.  
20 Follow-up conventional imaging will include MRI or CT (a diagnostic quality CT completed as part of a PET/CT scan is acceptable), the same approved PSMA PET as completed at baseline.  Note: 
Additional follow-up conventional imaging may be completed at any other timepoint, as deemed appropriate by the Investigator. All follow-up scans acquired within 180 days (±15 days) of Day 0 must be 
transferred to the central reading center. 
21 Additional follow-up conventional imaging may be performed at the discretion of the Investigator. Where feasible, obtaining histopathology from biopsy or surgery should be attempted for as many 64Cu-
SAR-BBN PET-positive lesions as possible (based on the local interpretation of the 64Cu-SAR-BBN PET/CT scans). If clinically feasible, the Investigator should make every effort to obtain histopathology 
for at least one 64Cu-SAR-BBN PET-positive lesion per region. All follow-up scans and histopathology acquired within 180 days (±15 days) of Day 0 must be transferred to the central reading center. 
22 Pre-SAR-BBN Disease Management Form must be completed by the treating physician to document the initial intended management plan for the participant based on available clinical information and 
conventional imaging results. 
23 Post-SAR-BBN Disease Management Form must be completed by the treating physician for all participants who complete the 64Cu-SAR-BBN PET/CT scan(s). The management plan will be based on the 
result from the local interpretation of the 64Cu-SAR-BBN PET/CT scan(s) to document whether a change to the initial intended management plan may be warranted due to the 64Cu-SAR-BBN PET/CT 
finding(s). 
prostate-specific antigen. 

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8.1 Demographics and Baseline Health Record  
8.1.1 Baseline Demographics 
Participant demographics will be recorded, including year of birth, gender, race, ethnicity.  
Baseline disease characteristics will be recorded, including initial diagnosis stage (per 
American Joint Committee on Cancer), initial Gleason score, initial diagnosis stage (T, N and 
M staging), pathology results, date of biochemical recurrence, relevant symptom history 
including, gastrointestinal, genitourinary and musculoskeletal. 
8.1.2 Medical and Medication History 
Medical history will include evaluation for relevant past or present diseases or disorders, and 
relevant surgical history.  
Medication history includes any medication or vaccine (including over the counter or 
prescription medicines, vitamins, and/or herbal supplements) that the participant is receiving 
within 14 days before signing informed consent must be recorded on the eCRF along with: 
• Reason for use; 
• Dates of administration including start and end dates; 
• Dosage information including dose and frequency. 
8.1.3 Prior Cancer Treatments and Therapies 
As part of Screening assessments, review of prior PC treatments and therapies received from 
the time of diagnosis will be completed and recorded on the eCRF. This must include type 
and date of the initial definitive treatment modality (e.g., radical prostatectomy, radiation 
therapy, cryotherapy, or brachytherapy) and any ADT received.  
8.2 Safety Assessments 
8.2.1 Physical Examination 
Full physical examinations will be performed by a registered physician (or qualified delegate). 
The full physical examination will include examination of the following: general appearance, 
cardiovascular system, respiratory system, and nervous system if vertebral involvement. 
Any findings made during the physical examination must be noted regardless of if they are part 
of the participant’s medical history. 
Clinically significant observations will be recorded as AEs.  
Note: Additional symptom directed physical examinations may also be performed at any time 
through the study as clinically indicated. 
8.2.2 Body Weight and Height  
Body weight (in kg) (wearing light clothes, no shoes) and height (in cm) will be measured 
(rounded to one decimal place). 

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8.2.3 Eastern Cooperative Oncology Group Performance Status 
The ECOG (Table 6) is used by the Investigator to determine the score (0 to 5) that best 
represents the participants’ activity status. 
Table 6 Eastern Cooperative Oncology Group Performance Status Scale 
Grade 
ECOG Performance Status 
0 
Fully active, able to carry on all pre-disease performance without restriction 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or 
sedentary nature, e.g., light house work, office work 
2 
Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about 
more than 50% of waking hours 
3 
Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 
4 
Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 
5 
Dead 
Abbreviations: ECOG=Eastern Cooperative Oncology Group  
8.2.4 Vital Signs 
Vital signs measurements will include body temperature, respiratory rate, heart rate and 
systolic and diastolic blood pressure. Wherever possible, vital signs will be recorded after the 
participant has rested comfortably in a seated position with feet on the floor or in a supine 
position for at least 3 minutes (the position must be the same for a particular participant pre 
and post dose) and using consistent methods between participants. 
Clinically significant observations, as deemed by the Investigator, will be recorded as AEs.  
8.2.5 12-lead Electrocardiogram 
Duplicate 12-lead ECGs will be performed after the participant has rested comfortably in the 
supine position for at least 3 minutes. 
The following parameters will be assessed: heart rate, PR, RR, QRS, QT, QTcB (Bazett 
formula), QTcF (Fridericia formula). The Investigator (or a qualified delegate at the 
investigational site) will interpret the ECG using one of the following categories: within normal 
limits, abnormal but not clinically significant, or abnormal and clinically significant. 
Clinically significant observations, as deemed by the Investigator, will be recorded as AEs.  
8.2.6 Clinical Laboratory Safety Assessments 
Safety clinical laboratory samples will be analyzed at by the site’s local laboratory.  
Blood samples will be collected for the following tests: 
• Hematology: Hemoglobin, hematocrit, red blood cell count, WBC, platelet count, 
differential WBC (neutrophils, eosinophils, basophils, lymphocytes, and monocytes), 
absolute neutrophil count, and absolute lymphocyte count.  
• Biochemistry (pre-prandial): albumin, total protein, blood glucose, sodium, 
potassium, blood urea nitrogen, creatinine, calcium, uric acid, aspartate 
aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase.  

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• eGFR: will be calculated from creatinine using the Chronic Kidney Disease 
Epidemiology Collaboration (CKD-EPI) formula and reported as mL/min. To convert 
mL/min/1.73m2 to mL/min, multiply by the individual’s Body Surface Area 
(calculated using the Mosteller formula) and divide by 1.73.  
• Coagulation: prothrombin time, activated partial thromboplastin time, D-dimer. Note: 
Coagulation may be assessed at any other timepoint, than specified in the Schedule of 
assessments, in case of an abnormal result, and followed until resolution. 
• Biochemical markers: Serum testosterone. 
Urine samples will be collected for the following tests: 
• Urinalysis: to include determination of glucose, protein, nitrites and leukocytes 
(dipstick test).  
In the event of an unexplained, clinically significant abnormal laboratory test result, the test 
should be repeated and followed up until it has returned to the normal range and/or an adequate 
explanation of the abnormality is found.  
During the study, all out of range (abnormal) laboratory values, except for PSA, must be 
evaluated and commented on by the Investigator (or a qualified delegated observer at the 
investigational site) for clinical significance using one of the following categories: within 
normal limits, abnormal but not clinically significant, or abnormal and clinically significant. 
Clinically significant observations will be recorded as AEs unless they are associated with a 
diagnosis that itself has been reported as an AE (e.g., raised white cells and fever associated 
with an infection – in this case the infection is the AE and the lab value and fever are signs and 
symptoms of the AE and should not be reported separately).   
8.2.7 Total Prostate Specific Antigen 
As part of Screening, baseline PSA will be assessed; additionally, PSA results and dates of 2 
previous most recent measurements (prior measurements are needed to assess PSA 
velocity/doubling time), PSA at initial diagnosis and PSA after initial definitive treatment 
(nadir) must also be recorded on the eCRF. 
Prostate-specific antigen will further be assessed during the Follow-Up as specified in the 
Schedule of assessments. However, if radiation therapy or other salvage focal therapy (e.g., 
cryotherapy) is initiated during the study (as long as no concomitant ADT is given), PSA levels 
must be monitored every 4 weeks from the initiation of the therapy. Prostate-specific antigen 
response (defined as total PSA decline by ≥50% from baseline) must be confirmed by a second 
value within 4 weeks. 
8.3 Imaging Assessments 
8.3.1 Baseline Conventional Scans 
Conventional imaging including an approved PSMA PET (such as 18F-DCFPyL or 68Ga-
PSMA-11) and a CT and/or MRI must be performed within 60 days of Day 0. A diagnostic 
quality CT completed as part of a PET/CT scan is acceptable to serve as baseline anatomical 
imaging. 

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Any other available conventional scan(s) that is acquired within 60 days of Day 0 must also be 
reviewed as part of Screening to confirm study eligibility (e.g., whole-body 99mTc-MDP, 18F-
NaF, 18F-fluciclovine, 11C-choline scan, etc).  
For each imaging modality, the date of acquisition and result (as positive, negative or equivocal 
for recurrent PC) must be reported on the eCRF. If equivocal, the site(s) of equivocal disease 
is also to be reported. All conventional scans will be assessed as per the site’s local standard 
procedures. 
All available scans completed within 60 days of Day 0 will be transferred in Digital Imaging 
and Communications in Medicine (DICOM) format to the central reading center with 
anonymization of participant specific information as specified in the Image Acquisition 
Manual. 
8.3.2 
64Cu-SAR-BBN PET/CT  
The site will conduct the quantitative PET/CT according to the Image Acquisition Manual, 
which contains details of scan acquisition, processing parameters and quality assurance 
procedures. For a given participant, the same scanner must be used for all scan acquisition 
timepoints. 
Participants will be asked to void prior to imaging. After voiding, a whole-body low dose CT 
and PET scan will be acquired starting from the mid-thigh to the skull vertex. 
The PET/CT images will be transferred in DICOM format to the central reading center with 
anonymization of participant specific information as specified in the Image Acquisition 
Manual. 
8.3.2.1 
64Cu-SAR-BBN PET/CT Local Interpretation 
The 64Cu-SAR-BBN PET/CT scans will be interpreted locally by an appropriately qualified 
Investigator in a non-blinded fashion.  
The reader will be required to evaluate the PET scans individually for the presence of 
pathological 64Cu-SAR-BBN uptake in the prostate bed/gland, pelvic lymph nodes, extra pelvic 
lymph nodes, visceral/soft tissue and bone. Computed tomography scans from the PET/CT will 
be available to the readers to guide anatomical localization. 
A 64Cu-SAR-BBN PET-positive lesion will be defined as focal uptake that is greater than 
physiologic background uptake in that tissue34 or greater than adjacent background if no 
physiologic uptake is expected and judged by the reader to be suspicious for disease. The 
number of PET-positive lesion(s) in each anatomical subregion will be documented.  
Any incidental findings on the 64Cu-SAR-BBN PET/CT scan(s) that are of potential clinical 
relevance and are not directly associated with the objectives of the protocol should be evaluated 
and handled by the Investigator as per standard medical/clinical judgment. 
The processes for image acquisition, transmittal, and interpretation, including the list of regions 
and subregions to be assessed on the 64Cu-SAR-BBN PET/CT are detailed in the Image 
Acquisition Manual. 
8.3.2.2 
64Cu-SAR-BBN PET/CT Central Interpretation 
The central reading center will receive and evaluate the 64Cu-SAR-BBN PET/CT scans. The 
scans will be interpreted by three different independent blinded readers in a random order at 
separate reading sessions. Central readers will be blinded as described in Section 5.3. 

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Computed tomography scans from the 64Cu-SAR-BBN PET/CT will be available for anatomic 
correlation. 
The readers will be required to evaluate the PET scans individually for the presence of 
pathological 64Cu-SAR-BBN uptake in the prostate bed/gland, pelvic lymph nodes, extra pelvic 
lymph nodes, visceral/soft tissue and bone. The same 64Cu-SAR-BBN PET-positive lesion 
definition will be applied as for the local interpretation. Lesions that do not meet the criteria 
for a positive lesion but are deemed suspicious for PC will be recorded as equivocal. The 
number of lesion(s) in each anatomical subregion will be documented. The size (two axial 
dimensions), location, standardized uptake value (SUV)mean and max, lesion-to-background 
ratio and reader confidence level will be recorded for up to 15 soft tissue lesions and 10 bone 
lesions by the central readers.  
The processes for image acquisition, transmittal, and interpretation are detailed in the Image 
Acquisition Manual and Imaging Review Charter. 
8.3.3 Follow-up Conventional Imaging 
Follow-up conventional imaging must be acquired for all participants as specified in the 
Schedule of Assessments, regardless of the 64Cu-SAR-BBN PET/CT findings.  
The follow-up conventional imaging must include the same modality/modalities as the 
conventional imaging performed at baseline to allow for reproducible and accurate 
comparisons. This should include anatomical imaging (MRI or CT; a diagnostic quality CT 
completed as part of a PET/CT scan is acceptable), and the same approved PSMA PET as 
completed at baseline. Scan acquisition will be completed according to institutional protocols. 
The imaging modality, date of acquisition and result (including number of lesions suspicious 
for PC within each anatomical subregion) must be recorded on the eCRF. 
All scans will be transferred in DICOM format to the central reading center with anonymization 
of participant specific information as specified in the Image Acquisition Manual. 
Note: Additional follow-up conventional imaging may be completed at any other timepoint, 
outside of those specified in the Schedule of assessments, as deemed appropriate by the 
Investigator. All follow-up scans acquired within 180 days (±15 days) of Day 0 must be 
transferred to the central reading center. 
8.4 Histopathology 
Where clinically feasible, histopathology (from image-guided biopsy or surgery [e.g., salvage 
pelvic lymph node dissection]) should be obtained for as many 64Cu-SAR-BBN PET-positive 
lesions as possible based on the local interpretation of the 64Cu-SAR-BBN PET/CT scans. If 
clinically feasible, the Investigator should make every effort to obtain histopathology for at 
least one 64Cu-SAR-BBN PET-positive lesion per region. The biopsy or surgery specimens 
will be processed and analyzed locally.  
The procedure, date of assessment, imaging modality used to guide biopsy (if applicable) and 
local histopathology result will be recorded on the eCRF. 
For participants undergoing image-guided needle biopsy, the needle biopsy images (e.g., CT, 
transrectal ultrasound-MRI, ultrasound) of the procedure will be sent to central reading center. 
The instruction for capturing biopsy images and directions for submitting the images to the 
central reading center is specified in the Image Acquisition Manual.  

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All histopathology results (and any associated images) acquired within 180 days (±15 days) of 
Day 0 must be transferred to the central reading center. 
 
8.5 Prostate Cancer Treatments 
Any PC treatment that the participant receives during the study must be recorded on the eCRF.  
This includes single agent or combination in order of administration, start and stop dates, 
dose(s), and schedule(s), the disease state in which it was administered (biochemical recurrence 
or M1; for M1 specify if node, visceral/soft tissue or bone), response (resistant or sensitive) on 
the basis of PSA if appropriate; and type of progression (PSA, radiographic [bone, nodal, 
visceral], clinical [e.g., pain escalation]) if applicable. 
For radiation therapy, target region(s), dose (Gy) and number of fractions should be recorded. 
 
8.6 Diagnostic Efficacy Assessments 
8.6.1 Assessment of the Composite Reference Standard  
The composite Reference Standard may consist of histopathology, conventional imaging 
modalities that are routinely used in the diagnosis and staging of PC and PSA levels. 64Cu-
SAR-BBN scans will not form part of the Reference Standard. 
The Reference Standard status will be determined by an independent, blinded, central expert 
panel. The expert panel will establish the Reference Standard disease status (on a participant- 
and region-level) for each participant individually, using information provided by the site’s 
Investigator. The experts will be blinded as described in Section 5.3. 
The Investigator will be required to submit all relevant clinical evidence available for the 
participant to enable the assessment of the Reference Standard. Relevant evidence will include: 
• All available histopathology reports related to the participants disease history;  
• All available conventional scans and related local reports collected as part of Screening 
(within 60 days of Day 0) and Follow-up (within 180 days [±15 days] of Day 0); 
• PSA levels recorded as part of Screening and Follow-up; 
• All available PC related symptom and treatment history. 
The composite Reference Standard will be hierarchical in nature, with three levels of evidence 
that will be applied as follows: 
• Level 1: Evaluable histopathology from biopsy or surgery OR in case that 
histopathology is not available, inconclusive or negative: 
• Level 2: Conventional imaging procedures OR if neither histopathology or 
conventional imaging are available or informative: 
• Level 3: Confirmed PSA response following radiation or other salvage focal therapy 
(as long as no concomitant ADT is given), defined as total PSA decline by ≥50% from 
baseline, confirmed by a second value within four weeks as per the Prostate Cancer 
Working Group 3 criteria35. 
The expert panel will use the collective information to determine and record each region with 
histopathology demonstrating PC, the number of lesions suspicious for PC detected on 

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conventional imaging in each anatomical subregion and whether the participant achieved 
confirmed PSA response (if applicable).  
Region(s) with no histopathology demonstrating PC or no unequivocal lesion recorded in any 
of the anatomical subregions on conventional imaging will be deemed negative for the region 
level Reference Standard status. 
Region(s) with histopathology demonstrating PC will qualify the region as positive for the 
region level Reference Standard status. A subregion with at least one unequivocal lesion (or 
cluster of lesions or diffuse sclerotic metastasis) on conventional imaging will qualify the 
subregion as positive for the Reference Standard status.  
If the expert panel judged that the available information is insufficient to provide a reliable 
conclusion, the result will be recorded as non-evaluable (e.g., no follow-up assessments were 
completed). The reason for selecting a non-evaluable or inconclusive result will be 
documented.  
Further details on the process and interpretation of the conventional imaging will be provided 
in the Imaging Review Charter. 
8.6.2 Assessment of Reference Standard against the 64Cu-SAR-BBN PET/CT Results 
For the assessment of the Reference Standard against the 64Cu-SAR-BBN PET/CT, region-
level matching will be used for histopathology, subregion-level matching for imaging, and 
participant-level matching for PSA response to radiation or other salvage focal therapy (refer 
to Section 8.6.1). Matching the Reference Standard against the 64Cu-SAR-BBN PET/CT 
results will be completed via statistical programming. 
Assessment of region-level Reference Standard against the 64Cu-SAR-BBN PET/CT results: 
• Histopathology: A region that is 64Cu-SAR-BBN PET-positive (i.e., includes at least 
one unequivocal PET-positive lesion) and Reference Standard positive, will be 
assigned as true positive (TP) for the region-level status. 
• Imaging: A subregion that is 64Cu-SAR-BBN PET-positive (i.e., includes at least one 
unequivocal PET-positive lesion) and Reference Standard positive (i.e., includes at 
least one unequivocal lesion detected on conventional imaging in that subregion), will 
be assigned as TP. A region that includes at least one TP subregion will be assigned as 
TP for the region-level status.  
• A region that is 64Cu-SAR-BBN PET-positive (i.e., includes at least one unequivocal 
PET-positive lesion) and is Reference Standard negative based on at least 1 evaluable 
timepoint, will be assigned as false positive (FP) for the region-level status. 
• A region that is 64Cu-SAR-BBN PET-negative (i.e., no unequivocal PET-positive 
lesion or only equivocal lesion(s) detected within the subregions) and Reference 
Standard negative, will be assigned as true negative (TN) for the region-level status. 
• A region that has either a non-evaluable 64Cu-SAR-BBN result for a specific timepoint 
or has a non-evaluable or inconclusive Reference Standard will not be assigned for that 
timepoint. 
Assessment of participant-level Reference Standard against the 64Cu-SAR-BBN PET/CT 
results: 

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• A participant with at least one TP region AND/OR at least one unequivocal 64Cu-SAR-
BBN PET-positive lesion and confirmed PSA response to radiation or other salvage 
focal therapy, will be assigned as TP for the participant-level status.  
• A participant with at least one unequivocal 64Cu-SAR-BBN PET-positive lesion who 
does not meet the above criteria to be deemed TP, will be assigned as FP for the 
participant-level status. 
• A participant with a negative 64Cu-SAR-BBN PET/CT (i.e., no unequivocal PET-
positive lesion or only equivocal lesion(s) detected on the scan) and negative Reference 
Standard, will be assigned as TN for the participant-level status. 
• A participant that has either a non-evaluable 64Cu-SAR-BBN result for a specific 
timepoint or has a non-evaluable or inconclusive Reference Standard will not be 
assigned for that timepoint. 
False negative results (on a region- or participant-level) will not be assigned in the study. A 
participant with negative baseline conventional imaging and negative 64Cu-SAR-BBN PET/CT 
imaging, who later demonstrates a positive result at follow-up conventional imaging (e.g., 
during the 90-day follow-up imaging) will not be considered a false negative as there is no way 
to determine whether the disease was initially present, or whether the disease has developed 
since the acquisition of the baseline and 64Cu-SAR-BBN imaging. A positive follow-up scan 
must therefore be interpreted with caution as it may reflect a different disease state compared 
to the one evaluated during the baseline conventional and 64Cu-SAR-BBN PET/CT imaging 
period. 
A positive 64Cu-SAR-BBN PET/CT within the target study population may indicate that this 
new imaging agent is more sensitive in detecting early recurrence than other available 
modalities. The 90- and 180-day follow-up timelines have been selected to allow for further 
development of the disease so the positive 64Cu-SAR-BBN PET/CT findings can be validated 
using conventional, potentially less sensitive reference modalities. The selected follow-up 
timelines therefore enable evaluation of the diagnostic efficacy endpoints that relate to positive 
findings, but do not allow for a reliable assessment of false negative results. 
8.6.3 Disease Management Plan 
The treating physician will be required to fill out a Pre-SAR-BBN and a Post-SAR-BBN 
Disease Management Form to provide information on the treatment strategy of the participant 
before and after the information from the local read of the 64Cu-SAR-BBN PET/CT scan(s) 
becomes available. 
The Pre-SAR-BBN Disease Management Form must be completed during Screening by the 
treating physician to document the initial intended management plan for the participant based 
on available clinical information and conventional imaging results. 
The Post-SAR-BBN Disease Management Form must be completed by the treating physician 
for all participants who complete the 64Cu-SAR-BBN PET/CT scan(s). This management plan 
will be based on the result from the local interpretation of the 64Cu-SAR-BBN PET/CT scan(s) 
to document whether a change to the initial intended management plan may be warranted due 
to the 64Cu-SAR-BBN PET/CT finding(s). Additionally, the operator will be asked to indicate 
which 64Cu-SAR-BBN PET/CT timepoint has influenced the assessment. If both timepoints 
influenced the assessment (whether for change or not) both should be selected. 

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8.7 Pharmacokinetics  
8.7.1 Biodistribution of 64Cu-SAR-BBN 
The biodistribution of 64Cu-SAR-BBN utilizing the PET/CT scans will involve the calculation 
of: 
• 
Maximum and mean SUVs in lesion(s), visceral/soft tissue, bone; 
• 
Lesion-to-background ratio. 
All biodistribution measures will be assessed centrally, according to the study Imaging Review 
Charter to ensure a high and consistent level of quantification across all sites. 
 
 

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9 VISIT-SPECIFIC PROCEDURES 
9.1.1 Screening Period  
9.1.1.1 Visit 1 (Day -28 to Day 0) 
The following assessments must be performed/obtained within the 28 days before the 
participant receives the 64Cu-SAR-BBN administration. Informed consent must be documented 
before any study-specific screening procedure is performed and may be obtained more than 28 
days before the 64Cu-SAR-BBN administration.  
Results of SOC tests or examinations performed prior to obtaining informed consent and within 
28 days (within 60 days for the conventional scans) prior to the 64Cu-SAR-BBN administration 
may be used; such tests do not need to be repeated for screening. 
If the start date for the 64Cu-SAR-BBN administration extends beyond 28 days from the start 
of the screening assessments (e.g., due to issues related to logistics), the Investigator in 
consultation with the Medical Monitor must determine if any screening assessments need to be 
repeated. 
Assessments to be completed: 
• 
Informed Consent (Refer to Section 12.512.5) 
• 
Inclusion/Exclusion Criteria (Refer to Section 5.1) 
• 
Demographic Data (Refer to Section 8.1.1) 
• 
Medical and Medication History (Refer to Section 8.1.2) 
• 
Prior Cancer Treatments (Refer to Section 8.1.3) 
• 
Body Weight and Height (Refer to Section 8.2.2) 
• 
ECOG Status (Refer to Section 8.2.3) 
• 
Hematology (Refer to Section 8.2.6) 
• 
Biochemistry (Refer to Section 8.2.6) 
• 
Coagulation (Refer to Section 8.2.6) 
• 
eGFR (CKD-EPI formula) (Refer to Section 8.2.6) 
• 
Serum Testosterone (refer to Section 8.2.6) 
• 
Total PSA (Refer to Section 8.2.7) 
• 
Conventional Imaging (Refer to Section 8.3.1) 
• 
Adverse Events (ongoing) (Refer to Section 10.1) 
• 
Concomitant Medications (ongoing) (Refer to Section 7) 
• 
Pre-SAR-BBN Disease Management Form (Refer to Section 8.6.3) 
9.1.2 
64Cu-SAR-BBN PET/CT Imaging  
9.1.2.1 Visit 2 (Day 0) 
Enrolled participants who meet all eligibility criteria will receive a single 64Cu-SAR-BBN 
administration followed by a PET/CT scan. Pre-dose assessments will be completed prior to 
the administration of 64Cu-SAR-BBN. Post-dose assessments will be completed as per the 
assessment windows specified below. 
Assessments to be completed: 
• 
Adverse Events (ongoing) 
• 
Concomitant Medications (ongoing) 
Pre dose 

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• 
Body Weight (Refer to Section 8.2.2) 
• 
Physical Exam (Refer to Section 8.2.1) 
• 
Vital Signs (Refer to Section 8.2.4) 
• 
Duplicate 12-Lead ECG (Refer to Section 8.2.5) 
• 
Urinalysis (dipstick) (Refer to Section 8.2.6) 
64Cu-SAR-BBN Dose (Refer to Section 6.4 for dosing and administration details) 
Post dose 
• 
Vital Signs to be completed prior to the 64Cu-SAR-BBN PET/CT (Refer to Section 8.2.4) 
• 
Duplicate 12-Lead ECG to be performed at 30 min (±10 min) post 64Cu-SAR-BBN 
administration (Refer to Section 8.2.5) 
• 
64Cu-SAR-BBN PET/CT to be performed at 1 to 4 hours post 64Cu-SAR-BBN 
administration (Refer to Section 8.3.2) 
9.1.2.2 Visit 3 (24 hours ±6 hours Post Dose, Day 1) 
This visit is to take place approximately 24 hours after the 64Cu-SAR-BBN administration. 
Assessments to be completed: 
• 
Adverse Events (ongoing) 
• 
Concomitant Medications (ongoing) 
• 
64Cu-SAR-BBN PET/CT (Refer to Section 8.3.2) 
9.1.3 Safety Visit 
9.1.3.1 Visit 4 (Day 7 ± 2 days) 
This visit is to take place 7 days (± 2 days) after the 64Cu-SAR-BBN administration.  
Assessments to be completed: 
• 
Adverse Events (ongoing) 
• 
Concomitant Medications (ongoing) 
• 
Record Any Prostate Cancer Treatments (Refer to Section 8.1.4) 
• 
Physical Exam (Refer to Section 8.2.1) 
• 
Body Weight (Refer to Section 8.2.2) 
• 
Vital Signs (Refer to Section 8.2.4) 
• 
Hematology (Refer to Section 8.2.6) 
• 
Biochemistry (Refer to Section 8.2.6) 
• 
Coagulation (Refer to Section 8.2.6) 
• 
eGFR (CKD-EPI) (Refer to Section 8.2.6) 
• 
Urinalysis (Refer to Section 8.2.6) 
• 
Additional Imaging/Histopathology (Refer to Section 8.3.3 and 8.4) 
• 
Post-SAR-BBN Disease Management Form (Refer to Section 8.6.3) 
9.1.4 Follow-Up 
9.1.4.1 Visit 5 (Day 90 ± 15 days) 
This visit is to take place 90 days (± 15 days) after the 64Cu-SAR-BBN administration. All 
participants must complete this visit, regardless of the 64Cu-SAR-BBN PET/CT results. 
Participants who based on the central expert panel’s interpretation of the follow-up 
conventional imaging completed during Visit 5 are deemed: 

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• negative or equivocal for PC recurrence - must continue to Visit 6.  
• positive for PC recurrence - no further study visits are required. 
Assessments to be completed: 
• 
Record Any Prostate Cancer Treatments (Refer to Section 8.1.4) 
• 
Total PSA (Refer to Section 8.2.6) 
• 
Follow-up Conventional Imaging (Refer to Section 8.3.3)  
• 
Record Any Additional Imaging/Histopathology (Refer to Section 8.3.3 and 8.4) 
9.1.4.2 Visit 6 (Day 180 ± 15 days) 
This visit is to take place 180 days (± 15 days) after the 64Cu-SAR-BBN administration.  
Only participants who were deemed negative or equivocal for PC recurrence based on the 
follow-up conventional imaging (as per the central expert panel’s interpretation) completed 
during Visit 5 must complete Visit 6.  
If the participant is not returning to Visit 6, but additional imaging/histopathology was acquired 
within 180 days (± 15 days) of Day 0, the relevant details must be recorded on the eCRF and 
information submitted to the central reading center. 
Assessments to be completed: 
• 
Record Any Prostate Cancer Treatments (Refer to Section 8.1.4) 
• 
Total PSA (Refer to Section 8.2.6) 
• 
Follow-up Conventional Imaging (Refer to Section 8.3.3) 
• 
Record Any Additional Imaging/Histopathology (Refer to Section 8.3.3 and 8.4) 
 
 
 

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10 ADVERSE EVENT MONITORING 
10.1 Adverse Events 
An AE is defined as any untoward medical occurrence in a clinical investigation participant 
administered a pharmaceutical product, which does not necessarily have a causal relationship 
with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including 
an abnormal laboratory finding), symptom, or disease temporally associated with the use of an 
investigational product, whether or not related to the investigational product. All AEs, 
including observed or volunteered problems, complaints, or symptoms, are to be recorded on 
the appropriate eCRF. 
Adverse Events should be recorded from the time of informed consent until the completion of 
the Safety Visit. Adverse Events recorded before the administration of 64Cu-SAR-BBN will be 
classified as non-treatment emergent AEs. All AEs recorded after the investigational product 
administration will be classified as treatment emergent AEs (TEAEs). Non-related AEs will 
only be reported and followed up until the Safety Visit. All related AEs are to be followed up 
until resolved or judged to be no longer clinically significant, or until they become chronic to 
the extent that they can be fully characterized. An assessment should be made at the last study-
related visit for each patient. Certain long-term AEs cannot be followed until resolution within 
the settings of this protocol. In these cases, follow-up will be the responsibility of the treating 
physician. If during AE follow-up the case has progressed to the level of SAE, or if a new SAE 
is observed whose relationship to the study medication cannot be ruled out, the situation must 
be reported by the Investigator becoming aware of the information.   
Participants should be instructed to report any AE that they experience to the Investigator. 
Wherever possible, a specific disease or syndrome rather than individual associated signs and 
symptoms should be identified by the Investigator and recorded on the eCRF. However, if an 
observed or reported sign or symptom is not considered a component of a specific disease or 
syndrome by the Investigator, it should be recorded as a separate AE on the eCRF. 
Additionally, the condition that led to a medical or surgical procedure (e.g., surgery, 
endoscopy, tooth extraction, transfusion) should be recorded as an AE, not the procedure. 
Adverse events should be entered into the eCRF within 5 days of reporting. 
Clinically significant abnormal laboratory or other examination (e.g., ECG) findings that are 
detected during the study should be reported as AEs. The Investigator will exercise his or her 
medical and scientific judgment in deciding whether an abnormal laboratory finding, or other 
abnormal assessment is clinically significant. Clinically significant abnormal laboratory values 
occurring during the clinical study will be followed until repeat tests return to normal, stabilize, 
or are no longer clinically significant. Any abnormal test that is determined to be an error does 
not require reporting as an AE. 
Any event that in the opinion of the Investigator is solely due to the underlying disease should 
not be reported as an AE. 
10.1.1 Adverse Drug Reaction 
All noxious and unintended responses to a medicinal product related to any dose should be 
considered an adverse drug reaction. “Responses” to a medicinal product means that a causal 
relationship between a medicinal product and an AE is at least a reasonable possibility; i.e., the 
relationship cannot be ruled out. 

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10.1.2 Unexpected Adverse Drug Reaction 
An unexpected adverse drug reaction is defined as an adverse reaction, the nature or severity 
of which is not consistent with the applicable product information. For 64Cu-SAR-BBN, the 
reference safety information is included in the current IB. The reference safety information is 
reviewed yearly, and the periodicity of the review will be harmonized with the reporting period 
of the Development Safety Update Report. 
10.1.3 Assessment of Adverse Events by the Investigator 
The Investigator will assess the severity (intensity) of each AE according to Common 
Terminology Criteria for Adverse Events (CTCAE) criteria and will also categorize each AE 
as to its potential relationship to investigational product using the categories of related or not 
related. 
10.1.3.1 Assessment of Severity 
Severity of AEs will be graded according to the following definitions: 
The Investigator will make an assessment of severity (intensity) for each AE and SAE reported 
during the study using the National Cancer Institute (NCI) CTCAE V5.0 criteria. The 
assessments will be based on the Investigator’s clinical judgment. The severity of each AE and 
SAE recorded in the eCRF should be assigned to 1 of the following: 
Mild (Grade 1): 
Mild; asymptomatic or mild symptoms; clinical or diagnostic 
observations only; intervention not indicated. 
Moderate (Grade 2): 
Moderate; minimal, local or noninvasive intervention indicated; 
limiting age appropriate instrumental ADL*. 
Severe (Grade 3): 
Severe or medically significant but not immediately life-
threatening; hospitalization or prolongation of hospitalization 
indicated; disabling; limiting self-care ADL**. 
Life-threatening 
(Grade 4): 
Life-threatening consequences; urgent intervention indicated. 
Fatal (Grade 5): 
Death related to AE. 
Abbreviations: ADL=Activities of Daily Living 
*Instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing 
money, etc. 
**Self-care ADL refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and 
not being bedridden. 
10.1.3.2 Causality Assessment 
The Investigator is obligated to assess the relationship between investigational product and the 
occurrence of each AE/SAE. The Investigator will use clinical judgment to determine the 
relationship to 64Cu-SAR-BBN. Alternative causes, such as natural history of the underlying 
diseases, concomitant therapy, other risk factors, and the temporal relationship of the event to 
the investigational product will be considered and investigated. 

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The causal relationship of the AE to the investigational product or study procedures should be 
assessed by the Investigator (or medically qualified delegate) using the following 
classifications: 
Related: 
An AE that follows a temporal sequence from administration of 
the investigational product, or for which possible involvement of 
the investigational product cannot be ruled out, although factors 
other than the drug, such as underlying diseases, concurrent 
medical conditions, concomitant drugs and concurrent treatments, 
are also possibly responsible. 
Not related: 
An AE that does not follow a temporal sequence from 
investigational product administration and/or that can reasonably 
be explained by other factors, such as underlying diseases, 
concurrent medical conditions, concomitant drugs and concurrent 
treatments. 
10.2 Serious Adverse Event 
Any AE, due solely to the underlying disease or disease progression, should not be reported as 
an SAE, unless the study treatment contributed to the AE. 
An AE or adverse reaction is considered serious if, in the view of either the Investigator or 
Sponsor, it results in any of the following outcomes: 
• Death; 
• Life-threatening AE; 
Note: An AE or adverse reaction is considered “life-threatening” if, in the view of the 
Investigator or Sponsor, its occurrence places the participant at immediate risk of 
death. It does not include an event that, had it occurred in a more severe form, might 
have caused death.) 
• Requires hospitalization or prolongation of existing hospitalization; 
Note: Any hospital admission with at least 1 overnight stay will be considered an 
inpatient hospitalization. An emergency room visit without hospital admission will not 
be recorded as an SAE under this criterion, nor will hospitalization for a procedure 
scheduled or planned before signing of informed consent. However, unexpected 
complications and/or prolongation of hospitalization that occur during elective 
surgery should be recorded as AEs and assessed for seriousness. Admission to the 
hospital for social or situational reasons (e.g., no place to stay, live too far away to 
come for hospital visits) will not be considered inpatient hospitalizations. 
• A persistent or significant disability/incapacity or substantial disruption of the ability 
to conduct normal life functions; 
• A congenital anomaly/birth defect; 
• An important medical event; 
Note: Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered an SAE when, based upon appropriate 
medical judgment, they may jeopardize the participant and may require medical or 

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surgical intervention to prevent 1 of the outcomes listed above. Examples of such 
medical events include allergic bronchospasm requiring intensive treatment in an 
emergency room or at home, blood dyscrasias or convulsions that do not result in 
inpatient hospitalization, or the development of drug dependency or drug abuse. 
10.3 Serious Adverse Event Reporting – Procedures for Investigators 
10.3.1 Initial Reports 
All SAEs occurring from the time of consent until the Safety Visit must be reported within 24 
hours of the knowledge of the occurrence (this refers to any AE that meets any of the 
aforementioned serious criteria). All SAEs that the Investigator considers related to 
investigational product occurring until end of the Safety Visit must be reported to the Sponsor. 
To report an SAE, complete the SAE Report Form and email the completed SAE Report Form 
within 24 hours of awareness. An SAE Report Form will be supplied with the study binder. 
In addition to reporting the SAE to Sponsor (or designee), the Investigator must also notify the 
IRB which approved the study according to their requirements. Copies of all correspondence 
relating to reporting of any SAEs should be maintained in the site’s study files and will be 
checked routinely by the study monitor. 
If the Sponsor and the Investigator consider that the SAE is investigational product related (i.e., 
an adverse reaction) and unexpected it will be reported to the appropriate regulatory authorities 
by the Sponsor (or designee) within the pre-defined timelines. 
10.3.2 Follow-Up Reports 
The Investigator must continue to follow the participant until the SAE has subsided or until the 
condition becomes chronic in nature, stabilizes (in the case of persistent impairment), or the 
participant dies. 
Within 24 hours of receipt of follow-up information, the Investigator must update the SAE 
form and submit any supporting documentation (e.g., deidentified participant discharge 
summary, autopsy reports), if requested. 
10.4 Pregnancy 
Pregnancies occurring in a female partner of a participant after the first administration of the 
investigational product require immediate reporting. They must be reported within 24 hours 
after the Investigator has become aware of the pregnancy. A pregnancy report will be 
completed and sent within 24 hours of becoming aware of the pregnancy. The Investigator will 
collect follow-up information regarding the outcome of the pregnancy and any postnatal 
sequelae in the infant that must also be reported to the Sponsor or designee. Upon awareness 
of the outcome of the pregnancy, the Investigator must forward a follow-up Pregnancy Report 
with any relevant information.  
If the outcome of the pregnancy meets the criteria for immediate classification of an SAE (e.g., 
spontaneous abortion, stillbirth, neonatal death, or congenital anomaly), the Investigator will 
report the event within 24 hours of being notified of the pregnancy report. 
10.5 Expedited Reporting 
The Sponsor will report all relevant information about suspected unexpected serious adverse 
reactions that are fatal or life-threatening as soon as possible to the FDA and the IRBs, and in 

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any case no later than 7 calendar days after knowledge by the Sponsor of such a case, and 
relevant follow-up information will subsequently be communicated within an additional 8 
days.  
All other suspected unexpected serious adverse reactions will be reported to the FDA and the 
IRBs as soon as possible but within a maximum of 15 calendar days of first knowledge by the 
Sponsor.  
The Sponsor will also inform all Investigators as required.  
 
 

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11 STATISTICAL METHODS 
11.1 General Considerations 
A Statistical Analysis Plan (SAP) will be written after finalizing the protocol and prior to 
database lock. The SAP will detail the implementation of all the planned statistical analysis in 
accordance with the principal features stated in the protocol. Any deviations from the SAP will 
be presented in the final clinical study report. 
Continuous variables will be summarized by the number of subjects, mean, standard deviation, 
standard error of the mean, median, 25th quartile, 75th quartile, minimum, and maximum 
values.  
Categorical variables will be summarized using frequency counts and percentages. 
11.2 Analysis Populations 
11.2.1 Enrolled Analysis Set 
The Enrolled Analysis Set will include all participants who signed the ICF and were enrolled 
into the study. This analysis set will be used for patient disposition summaries.  
11.2.2 Safety Analysis Set 
The Safety Analysis Set will be used to assess all safety data and will include all participants 
who receive any amount of 64Cu-SAR-BBN. 
11.2.3 Full Analysis Set 
The Full Analysis Set (FAS) will include all participants who receive any amount of 64Cu-
SAR-BBN and have 64Cu-SAR-BBN PET/CT imaging results from at least one central reader. 
The FAS will be used for all efficacy analyses. 
11.2.4 Biodistribution Population 
The Biodistribution Analysis Set will include all participants in the Safety Analysis Set and 
have at least one biodistribution measure. 
11.3 Determination of Sample Size 
The co-primary endpoints include participant-level correct detection rate (CDR) or true 
positive detection rate and region-level positive predictive value (PPV). 
The assumed participant-level CDR of 64Cu-SAR-BBN PET/CT imaging is 35% in participants 
with PSMA-negative biochemical recurrence of PC. A sample size of 40 participants is 
estimated to provide more than 80% power to achieve a lower boundary of a 2-sided 95% exact 
binomial confidence interval (CI) about the estimated CDR that exceeds 15%. Accounting for 
a 20% non-evaluable rate (including lost to follow-up), approximately 50 participants will need 
to undergo 64Cu-SAR-BBN PET/CT in this study. 
For the co-primary efficacy endpoint of region-level PPV, assuming 60% of participants are 
estimated to have 64Cu-SAR-BBN PET/CT positive findings in this target population and each 
participant with positive findings has an average of 1.3 positive regions, then 40 participants 
are expected to produce approximately 31 positive regions. The assumed region-level PPV rate 
of 64Cu-SAR-BBN PET/CT imaging is approximately 60% in all PET positive regions. 
Therefore, a sample size of 40 participants (i.e., approximately 31 positive regions) is estimated 

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to provide more than 90% power to achieve a lower boundary of a 2-sided 95% exact binomial 
CI about the estimated region-level PPV that exceeds 30%. 
11.4 Analysis Methods 
11.4.1 Enrollment and Disposition 
Disposition of participants enrolled, treated, and completed the study will be summarized with 
reasons for study discontinuation for the Enrolled Analysis Set. The number and percentage of 
participants in each analysis set will also be presented.  
11.4.2 Demographic and Other Baseline Characteristics 
Baseline characteristics will be summarized for the Safety Analysis Set and the FAS. 
Demographic and baseline data including age, sex, race, ethnicity, ECOG status, weight, height 
and body mass index at baseline will be listed and summarized. Baseline PC characteristics, 
including but not limited to PC pathology results, PC staging, initial Gleason score, time from 
initial diagnosis, time from last biochemical recurrence, relevant symptom history, PSA level 
at baseline, and prior cancer treatment for PC will be summarized. 
11.4.3 Prior and Concomitant Medication  
Prior and concomitant medications will be coded using the latest version of the World Health 
Organization Drug dictionary and tabulated by the Anatomical Therapeutic Chemical class and 
preferred term for the Safety Analysis Set. Any PC treatment during the study will also be 
summarized in the same manner. 
Prior medications are defined as those medications which stopped prior to the administration 
of the investigational product. Concomitant medication are medications that are taken at least 
once after the start of the administration of the investigational product.    
Prostate cancer treatment received during the study will also be summarized. 
11.4.4 Safety Analysis 
Safety parameters will include AEs, SAEs, laboratory assessments, vital signs, and ECG 
analysis. Safety analyses in general will be descriptive and will be presented in tabular format 
with the appropriate summary statistics.   
All safety analyses will be conducted in the Safety Analysis Set.  
11.4.4.1 Adverse Event Analysis 
Adverse events will be coded using the latest version of Medical Dictionary for Regulatory 
Activities (MedDRA).  
A TEAE is any AE that occurs after the administration of the investigational product. 
TEAEs, TEAEs related to investigational product, TEAEs with grade 3 or higher, TEAEs with 
grade 3 or higher related to investigational product, and treatment-emergent SAEs will be 
tabulated by MedDRA system organ class and preferred term. 
Serious adverse events, AEs leading to study discontinuation and AEs leading to death will be 
listed by participant. 

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11.4.4.2 Laboratory Data Analysis 
Safety laboratory parameters and corresponding changes from baseline will be presented as 
descriptive statistics by visit. Shift tables based on the NCI-CTCAE v5.0 toxicity grading will 
be presented for selected laboratory parameter between baseline and the highest/lowest post-
baseline NCI-CTCAE v5.0 toxicity grade. Any clinically significant abnormalities in 
laboratory values will be listed. 
11.4.4.3 Vital Sign Analysis 
Vital signs at each scheduled time point and changes from baseline will be summarized using 
descriptive statistics. 
11.4.4.4 Electrocardiogram Analysis 
For ECGs, all standard parameters (heart rate, RR, PR, QRS, QT, QTcF, and QTcB as 
applicable) at each scheduled time point along with changes from baseline will be summarized 
using descriptive statistics. The incidence of notable ECG changes in maximum absolute QTcF 
and QTcB intervals (> 450, > 480, and > 500 ms) over all post-treatment evaluations, as well 
as in QTcF and QTcB maximum changes from baseline (> 30 and > 60 ms) over all post-dose 
evaluations will be summarized.  
A listing of ECG data will be provided.  
11.4.5 Efficacy Analysis 
Efficacy endpoints will be assessed using the FAS.  
11.4.5.1 Primary Efficacy Analyses 
The co-primary efficacy endpoints include the following: 
• Participant-level CDR on Day 0 scan;  
• Participant-level CDR on Day 1 scan;   
• Region-level PPV on Day 0 scan; 
• Region-level PPV on Day 1 scan. 
CDR on a participant-level for each central reader is defined as the proportion of TP 
participants out of all scanned participants who had at least 1 evaluable follow-up reference 
standard datapoint (as without any follow-up reference data it is not possible to determine if 
the participant is TP or not, which may bias the results) and will be calculated as follows: CDR 
= TP/(all scanned participants with at least 1 evaluable reference datapoint).  
Participants without a 64Cu-SAR-BBN PET/CT scan at a specific timepoint (Day 0 or Day 1) 
will be excluded from the participant-level CDR calculation for that timepoint. Participants 
with non-evaluable participant-level Reference Standard results will be excluded from the 
CDR calculation.  
PPV on a region-level for each central reader is defined as the proportion of TP regions out of 
all positive regions on the 64Cu-SAR-BBN PET/CT scan with corresponding evaluable 
composite Reference Standard data and will be calculated as follows: PPV = TP/(TP+FP). 
Regions that are not positive on the 64Cu-SAR-BBN PET/CT scan at a specific timepoint (Day 
0 or Day 1) will be excluded for the region-level PPV calculation for that timepoint.  

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The anatomic regions for lesions include the following: 
Region 
Description of Anatomic Region 
1 
Prostatic 
2 
Pelvic lymph nodes 
3 
Extra pelvic lymph nodes 
4 
Visceral/soft tissue 
5 
Bone 
 
The point estimates of CDR and PPV on Day 0 and on Day 1 will be computed along with the 
2-sided 95% exact binomial CIs using the Clopper-Pearson method. The primary efficacy 
analyses will be performed for each central reader. 
The following sensitivity analyses of the participant-level CDR and region-level PPV will be 
performed: 
• Based on all participants in the FAS regardless of whether there are reference datapoints 
collected. Missing data will be handled as follows: 
o Worst-case imputation: 
o For the participant-level CDR on Day 0 and on Day 1 based on FAS, 
participants with missing/non-evaluable composite Reference Standard data 
will be imputed as non-true positive and included in the denominator. 
o For the region-level PPV calculation on Day 0 and on Day 1 based on FAS, 
PET/CT positive regions with missing/non-evaluable corresponding 
composite Reference Standard data will be imputed as FP and included in 
the denominator. 
o Tipping Point Analysis:  
o In addition, to examine the impact of missing or non-evaluable composite 
Reference Standard data and evaluate the robustness of the results, a tipping 
point analysis will be performed as a sensitivity analysis for participant-
level CDR and region-level PPV based on the FAS, where participants with 
missing or non-evaluable composite Reference Standard data will be 
imputed as TP with probability of p ranging from 0 to 1 with an increment 
of 0.1 (p = 0 corresponds to none of the participants without Reference 
Standard information in a PET positive region will be imputed as true 
positive while p = 1 means all participants without Reference Standard 
information in a PET positive regions will be imputed as TP). 
Details of handling of missing data will be fully described in the SAP. 
11.4.5.2 Secondary Efficacy Analyses 
Secondary efficacy endpoints include the following: 
• Participant-level PPV on Day 0 and on Day 1; 
• Participant-level DR on Day 0 and on Day 1; 
• Participant-level FPR on Day 0 and on Day 1; 

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• Region-level FPR on Day 0 and on Day 1; 
• Participant-level discrepant PET negative rate between Day 0 and Day 1; 
• Participant-level TNR on Day 0 and on Day 1; 
• Region-level TNR on Day 0 and on Day 1. 
Secondary efficacy endpoints will be analyzed on the FAS. Point estimates and 2-sided 95% 
exact binomial CIs will be presented for each central reviewer separately. 
11.4.5.3 Exploratory Efficacy Analyses 
The exploratory efficacy endpoints include the following: 
• Proportion of participants with any change in intended PC treatment due to either the 
Day 0 or Day 1 scan; 
• Composite CDR, PPV and DR of the Day 0 and Day 1 scan; 
• CDR, participant- and region-level PPV and DR of the Day 0 and/or Day 1 scan as a 
function of baseline variables; 
• Relationship between PET-positivity (biodistribution measures such as SUVs and 
lesion-to-background ratio), versus true/false positivity and as a function of lesion 
location and size; 
• Difference in the number of lesions detected per participant on the Day 0 versus the 
Day 1 scan; 
• Lesion-level overall agreement rate on the Day 0 and Day 1 scans, on the Day 0 and 
reference scans, and on the Day 1 and reference scans; 
• PSA over time and change from baseline; 
• PSA velocity and PSA doubling time (PSADT) at the end of the study and at baseline. 
Binary exploratory endpoints will be summarized with points estimates and corresponding 2-
sided 95% exact binomial CIs based on the FAS.  
Difference in the number of lesions detected per participant on the Day 0 versus the Day 1 scan 
will be summarized descriptively and compared using a paired t-test. Other exploratory 
endpoints including PSA value at each scheduled time point and change from baseline, PSA 
velocity, and PSADT will be summarized using descriptive statistics.  
Descriptive statistics, graphical methods, and statistical modeling as appropriate may be used 
to explore the relationship between PET-positivity (biodistribution measures such as SUVs and 
lesion-to-background ratio) and true/false positivity. 
In addition, CDR, PPV and DR may also be assessed as a function of the following baseline 
variables: 
• PSA at baseline prior to the scan (<0.5, 0.5 - <1.0, 1.0 - <2.0, 2.0 - <5.0, ≥5); 
• PSADT; 
• PSA velocity; 
• Testosterone at baseline; 
• SUV mean and max; 

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• Lesion-to-background ratio; 
• Initial treatment received; 
• Any previous ADT administered; 
• PSMA PET at baseline (negative vs equivocal). 
11.4.6 Intra- and Inter-reader Reliability Assessments 
A subset of each central reader’s 64Cu-SAR-BBN PET/CT scans will be evaluated twice to 
assess the reproducibility of the readings and consistency among readers.   
The intra-reader variability of each reader will be assessed by calculating percent agreement 
(concordance) and Cohen’s pairwise kappa statistics along with the 95% CIs for the 
dichotomous results for all participants with two scan interpretations. 
For inter-reader variability, the agreement among the three independent readers will be 
assessed by calculating percent pairwise concordance and Fleiss’s overall multi-assessor kappa 
statistics and its 95% CIs. 
11.4.7 Biodistribution Analysis 
Biodistribution measures of 64Cu-SAR-BBN including maximum and mean SUVs in lesions, 
visceral/soft tissues, bone, and lesion-to-background ratios will be summarized descriptively 
for the Biodistribution Analysis Set. 
11.5 Interim Analysis 
There is no interim analysis planned for this study. 
11.6 Handling of Missing Data 
 
Exploratory sensitivity analyses of the primary endpoints will be performed using participants 
who had evaluable composite Reference Standard data. Additional sensitivity analyses based 
on all participant in the FAS using the worst case imputation method and tipping point analysis 
will also be performed to examine the impact of missing or unevaluable composite Reference 
Standard data. These methods are described in detail in Section 11.4.5.1. 
 
 

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12 STUDY ADMINISTRATION AND RESPONSABILITIES 
12.1 General Investigator Responsibilities 
The Investigator must ensure that: 
• He or she will personally conduct or supervise the study; 
• His or her staff and all persons who assist in the conduct of the study clearly understand 
their responsibilities and have their names included in the protocol specific Study 
Personnel Responsibility/Signature Log; 
• The study is conducted according to the protocol and all applicable regulations; 
• The protection of each participant’s rights and welfare is maintained; 
• Signed and dated informed consent and, when applicable, permission to use protected 
health information are obtained from each participant before conducting study 
procedures. If a participant withdraws permission to use protected health information, 
the Investigator will obtain a written request from the participant and will ensure that 
no further data will be collected from the participant; 
• The consent process is conducted in compliance with all applicable regulations and 
privacy acts; 
• The IRB complies with applicable regulations and conducts initial and ongoing reviews 
and approvals of the study; 
• Any amendment to the protocol is submitted promptly to the IRB; 
• Any significant protocol deviations are reported to the Medical Monitor, the Sponsor, 
and the IRB according to the guidelines at each study site; 
• Electronic case report form pages are completed within 5 days of each participant’s 
visit (unless required earlier for SAE reporting); 
• All SAEs and pregnancies are reported to the Sponsor or designee within 24 hours of 
knowledge and to the IRB per IRB requirements; 
• All safety reports are submitted promptly to the IRB, as per IRB requirements. 
12.2 Protocol Compliance 
The Investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol. 
12.3 Compliance with Ethical and Regulatory Guidelines 
The Investigator will ensure that this study is conducted in accordance with International 
Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals 
for Human Use, or with the laws and regulations of the country in which the research is 
conducted, whichever affords the greater protection to the study participant. For studies 
conducted under a USA Investigational New Drug (IND) application, the Investigator will 
ensure adherence to the basic principles of GCP as outlined in 21 Code of Federal Regulations 
(CFR) 312, subpart D, “Responsibilities of Sponsors and Investigators”; 21 CFR, Part 50, 
1998; and 21 CFR, Part 56, 1998. 

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This study is also subject to and will be conducted in accordance with 21 CFR, Part 320, 1993, 
“Retention of Bioavailability and Bioequivalence Testing Samples.” 
Because this is a “covered” clinical study, the Investigator will ensure adherence to 21 CFR, 
Part 54, 1998; a covered clinical study is any “study of a drug or device in humans submitted 
in a marketing application or reclassification petition subject to this part that the applicant or 
FDA relies on to establish that the product is effective (including studies that show equivalence 
to an effective product) or that make a significant contribution to the demonstration of safety.” 
This requires that Investigators and all sub-Investigators must provide documentation of their 
financial interest or arrangements with the Sponsor, or proprietary interests in the drug being 
studied. This documentation must be provided before participation of the Investigator and any 
sub Investigator in the study. The Investigator or sub Investigator agrees to notify the Sponsor 
of any change in reportable financial interests during the study and for 1 year following 
completion of the study. Study completion is defined as the date that the last participant has 
completed the protocol-defined activities. 
12.4 Institutional Review Board 
This protocol and any accompanying material to be provided to the participant (such as 
advertisements, participant information sheets, or descriptions of the study used to obtain 
informed consent) will be submitted by the Investigator to an IRB. Approval from the IRB 
must be obtained before starting the study and should be documented in a letter from the IRB 
to the Investigator specifying the protocol number, protocol version, protocol date, documents 
reviewed, and date on which the committee met and granted the approval. A signed protocol 
approval page, a letter confirming IRB approval of the protocol and informed consent, and a 
statement that the IRB is organized and operates according to GCP and the applicable laws and 
regulations must be forwarded to the Sponsor before screening participants for the study. 
Additionally, study sites must forward a signed Form FDA 1572 (Investigator Obligation 
Form) to the Sponsor before screening participants for study enrollment. 
Any modifications or amendments made to the protocol or ICF after receipt of the initial IRB 
approval must also be submitted to the IRB for approval before implementation. Only changes 
necessary to eliminate apparent immediate hazards to the participants may be initiated prior to 
IRB approval. In that event, the Investigator must notify the IRB, the Medical Monitor, and the 
Sponsor in writing within 5 working days after implementation. If a change to the protocol in 
any way increases the risk to the participant or changes the scope of the study, then written 
documentation of IRB approval must be received by the Sponsor before the amendment may 
take effect. Additionally, under this circumstance, information on the increased risk and/or 
change in scope must be provided to participants already actively participating in the study, 
and they must read, understand, and sign any revised informed consent document confirming 
willingness to remain in the study. 
The Investigator must ensure that all local regulations and reporting requirements to the IRB 
are met. 
12.5 Informed Consent Process 
Note: All references to “participant” in this section refer to the study participant or his legally 
authorized representative. 
The Sponsor (or its designee) will provide Investigators with multicenter ICFs for this study. 
Investigators may adapt the information to suit the needs of their institution, if necessary 
(although it must reflect the required elements of informed consent specified in 21 CFR Part 

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50.25). The final ICFs must be accepted by the Sponsor and approved by the IRB. Investigators 
must provide the Sponsor with an unsigned copy of the final ICFs before and after it is approved 
by the IRB. If any new information becomes available that might affect participants’ 
willingness to participate in the study, or if any amendments to the protocol require changes to 
the ICF, the Sponsor will provide Investigators with a revised ICF. 
Prior to participating in any study-related procedure, each participant must sign and date an 
IRB-approved ICF written in a language the participant can understand. The ICF should be as 
nontechnical as practical and understandable to the participant. The ICF must provide the 
participant with all the information necessary to make an informed decision about their 
participation in the study, including the nature and intended purpose of the study, possible 
benefits, possible risks, and disclosures of the participant’s personal information and personal 
health information for purposes of conducting the study. The ICF will include details of the 
requirements of the participant and the fact that he/she is free to withdraw at any time without 
giving a reason and without prejudice to their further medical care. Before informed consent is 
obtained, the participant should be given ample time and opportunity to inquire about the 
details of the study. All questions must be answered to the satisfaction of the participant. 
Once signed, the original ICF will be stored in the Investigator’s site file and made available 
for review by the Sponsor. Documentation of the informed consent discussion must be noted 
in the participant’s case history. All participants will receive a copy of their signed and dated 
ICF. 
If the ICF is revised during the study and requires the participant to be re consented, informed 
consent will be obtained in the same manner as for the original ICF. 
12.6 Confidentiality 
Every effort will be made to maintain the anonymity and confidentiality of all participants 
during this clinical study. However, because of the experimental nature of this investigational 
product, the Investigator agrees to allow the IRB, representatives of the Sponsor and its 
designated agents, and authorized employees of appropriate regulatory agencies to inspect the 
facilities used in this study and, for purposes of verification, allow direct access to the study 
site records of all participants enrolled into this study. This includes providing by fax, e-mail, 
or regular mail de-identified copies of clinical, laboratory, ECG, radiology, pathology, and/or 
other test results when requested by the Sponsor. A statement to this effect will be included in 
the ICF and a permission form authorizing the use of protected health information will also be 
included. 
In accordance with local and national participant privacy regulations, the Investigator or 
designee must explain to each participant that in order to evaluate study results, the 
participant’s protected health information obtained during the study may be shared with IRBs, 
the Sponsor and its designees, and regulatory agencies. It is the Investigator’s or designee’s 
responsibility to obtain written permission to use protected health information from each 
participant. If a participant withdraws permission to use protected health information, it is the 
Investigator’s responsibility to obtain the withdrawal request in writing from the participant 
and to ensure that no further data will be collected from the participant. Any data collected on 
the participant before withdrawal will be used in the analysis of study results. The Sponsor will 
only use or disclose the participant’s protected health information consistent as defined in the 
ICF. 
The Investigator must assure that each participant’s anonymity will be strictly maintained, and 
that each participant’s identity is protected from unauthorized parties. Only participant initials, 

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date of birth, and an identification code (but no participant names) should be recorded on any 
form or biological sample submitted to the IRB, to the Sponsor or its designees (e.g., 
laboratories), or to regulatory authorities. However, sufficient information must be retained at 
the study site to permit sample data and data in the database to be connected with the unique 
participant number assigned to each study participant. 
The Investigator agrees that all information received from the Sponsor, including, but not 
limited to, the investigational product, the IB, this protocol, the eCRFs, and any other study 
information remain the sole and exclusive property of the Sponsor during the conduct of the 
study and thereafter. This information is not to be disclosed to any third party (except 
employees or agents directly involved in the conduct of the study or as required by law) without 
prior written consent from the Sponsor. The Investigator further agrees to take all reasonable 
precautions to prevent the disclosure by any employee or agent of the study site to any third 
party or otherwise into the public domain. 
12.7 Study Files and Retention of Records and Biological Samples 
The Investigator must maintain adequate and accurate records to enable the conduct of the 
study to be fully documented and the study data to be subsequently verified by the IRB, 
representatives of the Sponsor and its designated agents, and authorized employees of 
appropriate regulatory agencies. These documents should be classified into at least the 
following 2 categories: Investigator’s study file and participant clinical source documents. 
The Investigator’s study file will contain the protocol/amendments, eCRF and query forms, the 
IRB and governmental approval with correspondence, signed ICF, drug accountability records, 
staff curriculum vitae and authorization forms (e.g., Form FDA 1572), and other appropriate 
documents and correspondence pertaining to the conduct of the study. 
The required source data referenced in the monitoring plan for the study should include 
sequential notes containing at least the following information for each participant: 
• Participant identification (name, date of birth, sex, race and ethnicity); 
• Documentation that participant meets each of the eligibility criteria, e.g., history, 
physical examination, and confirmation of diagnosis (to support inclusion and 
exclusion criteria); 
• Participation in study (including study number); 
• Study discussed and date of informed consent/re-consent; 
• Dates of all visits; 
• Documentation that protocol-specific procedures were performed; 
• Results of efficacy parameters, as required by the protocol; 
• Start and end date (including dose regimen) of investigational products (including 
relevant drug dispensing information); 
• Record of all AEs and other safety parameters (including start and end date, causality, 
and severity (intensity)); 
• Concomitant medications (including start and end date and dose if relevant dose 
changes occur); 
• Date of study completion and reason for discontinuation, if applicable. 

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All clinical study documents must be retained by the Investigator until at least 2 years after the 
last approval of a marketing application in an ICH region (the United States, Europe, or Japan) 
and until there are no pending or contemplated marketing applications in an ICH region; or, if 
no application is filed or if the application is not approved for such indication, until 2 years 
after the investigation is discontinued and regulatory authorities have been notified or for 15 
years, whichever is longer. Investigators may be required to retain documents longer if required 
by applicable regulatory requirements, by local regulations, or by an agreement with the 
Sponsor. The Investigator must notify the Sponsor and obtain written approval from the 
Sponsor before destroying any clinical study records. The Investigator will promptly notify the 
Sponsor in the event of accidental loss or destruction of any study records. The Sponsor will 
inform the Investigator of the date that study records may be destroyed or returned to the 
Sponsor. 
The Sponsor must be notified in advance and must provide express written approval of any 
change in the maintenance of the foregoing documents if the Investigator wishes to move study 
records to another location or assign responsibility for record retention to another party.  
If the Investigator cannot guarantee this archiving requirement at the study site for any or all 
of the documents, special arrangements must be made between the Investigator and the Sponsor 
to store these in sealed containers outside of the study site so that they can be returned sealed 
to the Investigator in case of a regulatory audit. When source documents are required for the 
continued care of the participant, appropriate copies should be made for storage outside of the 
study site. 
Biological samples retained by the Investigator will be stored and maintained by the 
Investigator until notification is received from the Sponsor that the retained samples and 
records no longer need to be retained. The Investigator must obtain written permission from 
the Sponsor before disposing of any retained samples. The Investigator should promptly notify 
the Sponsor in the event of accidental loss or destruction of any study samples. With the 
permission of the Sponsor, the retained samples may be transferred to an acceptable designee, 
such as another Investigator, another institution, a contract storage site, or to the Sponsor. 
12.8 Participant Screening Log 
The Investigator must keep a record that lists all participants who signed the ICF (including 
those who did not undergo screening assessments). For those participants who declined to 
participate, post signing the ICF or were subsequently excluded from enrollment, the reasons 
for not enrolling in the study must be described. 
12.9 Modifications of the Protocol or Informed Consent Documents 
Protocol modifications, except those intended to reduce immediate risk to study participants, 
will be made only by the Sponsor. All protocol modifications must be submitted to the IRB in 
accordance with local requirements. Except as noted in Section 12.4, IRB approval must be 
obtained before changes can be implemented. 
The ICF cannot be changed without prior written approval by the Sponsor and the study site’s 
IRB. 
The Sponsor may not reimburse the Investigator for cases in which study procedures and 
evaluations are not conducted in line with the IRB approved protocol. 

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12.10 
Case Report Forms 
Authorized study site personnel will complete eCRFs designed for this study according to the 
completion guidelines that will be provided. An eCRF is required and must be completed for 
each enrolled participant, with all required study data accurately recorded such that the 
information matches the data contained in medical records (e.g., physicians’ notes, nurses’ 
notes, study site charts, or other study-specific source documents). The Investigator will ensure 
that the eCRFs are accurate, complete, legible, and completed within 5 days of each 
participant’s visit (unless required earlier for SAE reporting). The Investigator will ensure that 
source documents that are required to verify the validity and completeness of data transcribed 
on the eCRFs are never obliterated or destroyed. As required by the protocol, eCRFs should 
also be completed for those participants who fail to complete the study (even during the 
screening period). If a participant withdraws from the study, the reason must be noted on the 
eCRF and thorough efforts should be made to clearly document outcome. 
The eCRFs for this study will exist within a web-based electronic data capture (EDC) system. 
After the Investigator or the Investigator’s designees (e.g., research coordinators) have been 
appropriately trained, they will be given access to the EDC system and will enter the data 
required by the protocol into the EDC system. Any change of data will be made via the EDC 
system, with all changes tracked by the system to provide an audit trail. 
The eCRF must be completed and signed by the principal Investigator or sub-Investigator (as 
appropriate) within a reasonable time period after data collection. This signature serves to attest 
that the information contained in the eCRF is true. 
12.11 
Clinical Monitoring 
Representatives of the Sponsor or its designee will monitor this study until completion. 
Monitoring will be conducted through personal visits with the Investigator and study site staff 
as well as any appropriate communications by mail, e-mail, or telephone. The monitor is 
responsible for routine review of the eCRFs at regular intervals throughout the study to verify 
adherence to the protocol and the completeness, consistency, and accuracy of the data being 
entered on them. The purpose of monitoring is to ensure compliance with the protocol and the 
quality and integrity of the data. 
In accordance with GCP, the study monitor must have direct access to the Investigator’s source 
documentation in order to verify the data recorded in the eCRFs for consistency. The 
Investigator agrees to cooperate with the monitor to ensure that any problems detected in the 
course of these monitoring visits are resolved. 
12.12 
Inspections 
The source documents for this study must be made available to appropriately qualified 
personnel from the Sponsor or its representatives, to the IRB, and to regulatory authority or 
health authority inspectors as a part of their responsibility to protect human participants in 
research. The Investigator agrees to provide access to records, facilities, and personnel for the 
effective conduct of any inspection or audit to representatives of the Sponsor and regulatory 
agencies. It is important that the Investigator and relevant institutional personnel are available 
during monitoring visits and possible audits or inspections and that sufficient time is devoted 
to the process. If the Investigator is notified of an inspection by a regulatory authority, the 
Investigator agrees to notify the Sponsor immediately. 

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12.13 
Data Management 
Electronic data capture will be used to enter study data eCRFs and to transfer the data into a 
study-specific electronic database. Instances where the eCRF captured data are considered 
source data will be outlined in separate study specific documentation. During the data 
collection process, automated quality assurance programs will be used to identify missing data, 
out-of-range data, and other data inconsistencies. Requests for data clarification or correction 
will be forwarded to the investigative study site for resolution. As appropriate, eCRFs, listings, 
tables, and SAS datasets will be provided to the study sites for review. 
Quality assurance and quality control systems will be implemented and maintained according 
to written standard operating procedures to ensure that the data are generated, recorded, and 
reported in compliance with the protocol, GCP, and applicable regulatory requirements. Data 
collection and storage systems will provide an audit trail, security mechanisms, and electronic 
signature capabilities that meet the requirements of FDA Title 21 of CFR Part 11 regarding 
electronic records and electronic signatures. 
Data security will be controlled through appropriate and specific restriction of access to only 
data and systems required by individual users to accomplish their roles in the data management 
process. Individual login and password protections will be employed at study sites and at the 
Sponsor or its designee. The database will exist on physically secured servers. Data backups 
will be done regularly and will be stored in separate facilities. Printed documents relating to 
the study will be secured when not under review.  
12.14 
Clinical Study Insurance 
The Sponsor will secure clinical study insurance. An insurance certificate will be made 
available to the participating study sites before study initiation. 
12.15 
Communications with Regulatory Authorities 
The Sponsor, working either directly or through designees, will assume responsibility for 
regulatory interactions with relevant regulatory authorities. The Sponsor will maintain an IND 
application for the investigational product in support of the study in the United States and will 
maintain similar regulatory applications with other regulatory authorities as required for 
conduct of the study. In fulfilling this responsibility, the Sponsor (or a designee) will collect, 
assemble, and communicate all required regulatory documents (e.g., Form FDA 1572, 
Investigator financial disclosure forms, protocol and protocol amendments, IB, informed 
consent documents, annual reports) as required by regulation. The Sponsor (or a designee) will 
also assume responsibility for safety reporting to regulatory authorities as described in 
Section 10.5. 
12.16 
Publication and Information Disclosure Policy 
All information provided by the Sponsor and all data and information generated by the site as 
part of the study (other than a participant’s medical records) are the sole property of Sponsor. 
For clinical interventional studies in patients, Sponsor will post study results on websites such 
as https://clinicaltrials.gov/ in accordance with FDA reporting rules.   
The results of this study may be published or presented at scientific meetings. If this is foreseen, 
the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission. 
This allows the sponsor to protect proprietary information and to provide comments. 

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The sponsor will comply with the requirements for publication of study results. In accordance 
with standard editorial and ethical practice, the sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual site data. In this case, a 
coordinating investigator will be designated by mutual agreement. 
Authorship will be determined by mutual agreement and in line with International Committee 
of Medical Journal Editors authorship requirements. 
12.17 
Study Discontinuation 
Both the Sponsor and the Investigator reserve the right to terminate the study at any time. 
Should this be necessary, both parties will arrange discontinuation procedures. The Investigator 
will be responsible for notifying the relevant study site’s IRB. The Sponsor will be responsible 
for notifying the appropriate regulatory authorities. In terminating the study, the Sponsor and 
the Investigator will assure that adequate consideration is given to the protection of the 
participants’ interests. As directed by the Sponsor, all study materials must be collected and all 
eCRFs completed to the greatest extent possible. 
 
 

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REFERENCES 
1. 
Michalski K, Kemna L, Asberger J, et al. Gastrin-Releasing Peptide Receptor 
Antagonist [68Ga]RM2 PET/CT for Staging of Pre-Treated, Metastasized Breast 
Cancer. Cancers. 2021;13(23):6106. 
2. 
Hirmas N, Leyh C, Sraieb M, et al. (68)Ga-PSMA-11 PET/CT Improves Tumor 
Detection and Impacts Management in Patients with Hepatocellular Carcinoma. 
Journal of nuclear medicine : official publication, Society of Nuclear Medicine. 
2021;62(9):1235-1241. 
3. 
Key Statistics for Prostate Cancer. 2021; https://www.cancer.org/cancer/prostate-
cancer/about/key-statistics.html. Accessed 10/29/2021, 2021. 
4. 
Bangma CH, Roobol MJ, Steyerberg EW. Predictive models in diagnosing indolent 
cancer. Cancer. 2009;115(13 Suppl):3100-3106. 
5. 
Hoffman RM. Screening for Prostate Cancer. New England Journal of Medicine. 
2011;365(21):2013-2019. 
6. 
Nelson WG, De Marzo AM, Isaacs WB. Prostate Cancer. New England Journal of 
Medicine. 2003;349(4):366-381. 
7. 
Rawla P. Epidemiology of Prostate Cancer. World J Oncol. 2019;10(2):63-89. 
8. 
Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA: a cancer journal for 
clinicians. 2017;67(1):7-30. 
9. 
Jensen RT, Battey JF, Spindel ER, Benya RV. International Union of Pharmacology. 
LXVIII. Mammalian bombesin receptors: nomenclature, distribution, pharmacology, 
signaling, and functions in normal and disease states. Pharmacol Rev. 2008;60(1):1-42. 
10. 
Baratto L, Duan H, Maecke HR, Iagaru A. Imaging the Distribution of Gastrin 
Releasing Peptide Receptors in Cancer. Journal of nuclear medicine : official 
publication, Society of Nuclear Medicine. 2020;61(6):792-798. 
11. 
Fleischmann A, Waser B, Reubi JC. High expression of gastrin-releasing peptide 
receptors in the vascular bed of urinary tract cancers: promising candidates for vascular 
targeting applications. Endocrine-related cancer. 2009;16(2):623-633. 
12. 
Markwalder R, Reubi JC. Gastrin-releasing peptide receptors in the human prostate: 
relation to neoplastic transformation. Cancer research. 1999;59(5):1152-1159. 
13. 
Morgat C, MacGrogan G, Brouste V, et al. Expression of Gastrin-Releasing Peptide 
Receptor in Breast Cancer and Its Association with Pathologic, Biologic, and Clinical 
Parameters: A Study of 1,432 Primary Tumors. Journal of nuclear medicine : official 
publication, Society of Nuclear Medicine. 2017;58(9):1401-1407. 
14. 
Baratto L, Song H, Duan H, et al. PSMA- and GRPR-targeted PET: Results from 50 
Patients with Biochemically Recurrent Prostate Cancer. Journal of nuclear medicine : 
official publication, Society of Nuclear Medicine. 2021;62(11):1545-1549. 
15. 
Hofman MS, Lawrentschuk N, Francis RJ, et al. Prostate-specific membrane antigen 
PET-CT in patients with high-risk prostate cancer before curative-intent surgery or 
radiotherapy (proPSMA): a prospective, randomised, multi-centre study. The Lancet. 
2020;395(10231):1208-1216. 
16. 
Afshar-Oromieh A, Holland-Letz T, Giesel FL, et al. Diagnostic performance of 
(68)Ga-PSMA-11 (HBED-CC) PET/CT in patients with recurrent prostate cancer: 
evaluation in 1007 patients. European journal of nuclear medicine and molecular 
imaging. 2017;44(8):1258-1268. 
17. 
Minamimoto R, Hancock S, Schneider B, et al. Pilot Comparison of (6)(8)Ga-RM2 
PET and (6)(8)Ga-PSMA-11 PET in Patients with Biochemically Recurrent Prostate 
Cancer. Journal of nuclear medicine : official publication, Society of Nuclear Medicine. 
2016;57(4):557-562. 

Investigational Product: 64Cu-SAR-BBN  
 Clarity Pharmaceuticals Ltd 
Protocol: CLB03  
 Version: 2.0, 27Feb2023 
 
 CONFIDENTIAL 
 Page 72 of 74 
18. 
Zimmerman ME, Meyer AR, Rowe SP, Gorin MA. Imaging of prostate cancer with 
positron emission tomography. Clinical advances in hematology & oncology : H&O. 
2019;17(8):455-463. 
19. 
Trabulsi EJ, Rumble RB, Jadvar H, et al. Optimum Imaging Strategies for Advanced 
Prostate Cancer: ASCO Guideline. Journal of clinical oncology : official journal of the 
American Society of Clinical Oncology. 2020;38(17):1963-1996. 
20. 
Minamimoto R, Senda M, Jinnouchi S, Terauchi T, Inoue T. Detection of prostate 
cancer by an FDG-PET cancer screening program: results from a Japanese nationwide 
survey. Asia Ocean J Nucl Med Biol. 2014;2(1):19-23. 
21. 
Alonso O, Dos Santos G, Garcia Fontes M, Balter H, Engler H. (68)Ga-PSMA and 
(11)C-Choline comparison using a tri-modality PET/CT-MRI (3.0 T) system with a 
dedicated shuttle. European journal of hybrid imaging. 2018;2(1):9. 
22. 
Schwenck J, Rempp H, Reischl G, et al. Comparison of (68)Ga-labelled PSMA-11 and 
(11)C-choline in the detection of prostate cancer metastases by PET/CT. European 
journal of nuclear medicine and molecular imaging. 2017;44(1):92-101. 
23. 
Savir-Baruch B, Zanoni L, Schuster DM. Imaging of Prostate Cancer Using 
Fluciclovine. The Urologic clinics of North America. 2018;45(3):489-502. 
24. 
Calais J, Ceci F, Eiber M, et al. (18)F-fluciclovine PET-CT and (68)Ga-PSMA-11 PET-
CT in patients with early biochemical recurrence after prostatectomy: a prospective, 
single-centre, single-arm, comparative imaging trial. The Lancet Oncology. 
2019;20(9):1286-1294. 
25. 
Wilkinson S, Chodak G. The role of 111indium-capromab pendetide imaging for 
assessing biochemical failure after radical prostatectomy. The Journal of urology. 
2004;172(1):133-136. 
26. 
Schaeffer EM, Srinivas S, Antonarakis ES, et al. NCCN Clinical Practice Guidelines in 
Oncology (NCCN Guidelines) - Prostate Cancer Version 3.2022. In: National 
Comprehensive Cancer Network; 2022. 
27. 
Kranzbuhler B, Nagel H, Becker AS, et al. Clinical performance of (68)Ga-PSMA-11 
PET/MRI for the detection of recurrent prostate cancer following radical 
prostatectomy. European journal of nuclear medicine and molecular imaging. 
2018;45(1):20-30. 
28. 
Zschaeck S, Andela SB, Amthauer H, et al. Correlation Between Quantitative PSMA 
PET Parameters and Clinical Risk Factors in Non-Metastatic Primary Prostate Cancer 
Patients. Frontiers in oncology. 2022;12. 
29. 
Mapelli P, Ghezzo S, Samanes Gajate AM, et al. (68)Ga-PSMA and (68)Ga-DOTA-
RM2 PET/MRI in Recurrent Prostate Cancer: Diagnostic Performance and Association 
with Clinical and Histopathological Data. Cancers. 2022;14(2). 
30. 
Touijer KA, Michaud L, Alvarez HAV, et al. Prospective Study of the Radiolabeled 
GRPR Antagonist BAY86-7548 for Positron Emission Tomography/Computed 
Tomography Imaging of Newly Diagnosed Prostate Cancer. European urology 
oncology. 2019;2(2):166-173. 
31. 
Afshar-Oromieh A, Malcher A, Eder M, et al. PET imaging with a [68Ga]gallium-
labelled PSMA ligand for the diagnosis of prostate cancer: biodistribution in humans 
and first evaluation of tumour lesions. European journal of nuclear medicine and 
molecular imaging. 2013;40(4):486-495. 
32. 
Hicks RJ, Jackson P, Kong G, et al. 64Cu-SARTATE PET imaging of patients with 
neuroendocrine tumours demonstrates high tumor uptake and retention, potentially 
allowing prospective dosimetry for peptide receptor radionuclide therapy. Journal of 
nuclear medicine : official publication, Society of Nuclear Medicine. 2019;60(6):777-
785. 

Investigational Product: 64Cu-SAR-BBN  
 Clarity Pharmaceuticals Ltd 
Protocol: CLB03  
 Version: 2.0, 27Feb2023 
 
 CONFIDENTIAL 
 Page 73 of 74 
33. 
Gourni E, Del Pozzo L, Kheirallah E, et al. Copper-64 Labeled Macrobicyclic 
Sarcophagine Coupled to a GRP Receptor Antagonist Shows Great Promise for PET 
Imaging of Prostate Cancer. Molecular pharmaceutics. 2015;12(8):2781-2790. 
34. 
Baratto L, Duan H, Laudicella R, et al. Physiological (68)Ga-RM2 uptake in patients 
with biochemically recurrent prostate cancer: an atlas of semi-quantitative 
measurements. European journal of nuclear medicine and molecular imaging. 2019. 
35. 
Scher HI, Morris MJ, Stadler WM, et al. Trial Design and Objectives for Castration-
Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer 
Clinical Trials Working Group 3. Journal of clinical oncology : official journal of the 
American Society of Clinical Oncology. 2016;34(12):1402-1418. 
 
 
 

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13 INVESTIGATOR AGREEMENT 
 
Protocol Number:   CLB03 
Protocol Title:  
64Cu-SAR-BBN Positron Emission Tomography: A Phase 2 Study of 
Participants with PSMA-negative Biochemical Recurrence of Prostate 
Cancer  
 
I have carefully read and understand the foregoing protocol and agree that it contains all the 
necessary information for conducting this study safely. I will conduct this study in strict 
accordance with this protocol, ICH guidelines for GCP, the Code of Federal Regulations, the 
Health Insurance Portability and Accountability Act, and local regulatory guidelines. I will 
attempt to complete the study within the time designated. I will ensure that the rights, safety, 
and welfare of participants under my care are protected. I will ensure control of the drugs under 
investigation in this study. I will provide copies of the protocol and all other study-related 
information supplied by the Sponsor to all personnel responsible to me who participate in the 
study. I will discuss this information with them to assure that they are adequately informed 
regarding the drug and conduct of the study. I agree to keep records on all participant 
information (case report forms, shipment and drug return forms, and all other information 
collected during the study) and drug disposition in accordance with FDA regulations. I will not 
enroll any participants into this protocol until IRB approval and Sponsor approval are obtained.  
 
 
 
 
 
 
 
 
 
 
Site or Institution Name 
 
 
 
 
 
 
 
 
 
 
Site number 
 
 
 
 
 
 
 
 
 
 
Investigator Name (Print) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator Signature  
 
 
 
 
Date