Optimizing Timing of rhPSMA-7.3 (18F) for Assessing Site(s) of Recurrent Disease Following Radical Prostatectomy
Phase: PHASE3
Conditions: Prostate Cancer
Sponsor: NYU Langone Health

Official Title: 
Optimizing timing of rhPSMA-7.3 (18F), for assessing site(s) of 
recurrent disease following radical prostatectomy
NCT Number:
NCT05678322
Study Number:
22-00547 
Document Type:
Study Protocol and Statistical Analysis Plan
Date of the 
Document: 
 
July 16, 2024 

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CONFIDENTIAL 
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authorized in writing by the study sponsor 
Interventional Template Version: 11 January 2019
 
 
 
 
 
 
Optimizing timing of rhPSMA-7.3 (18F), for assessing site(s) of recurrent disease 
following radical prostatectomy
Principal Investigator:
Herbert Lepor, MD
Professor and Martin Spatz Chair of Urology 
Professor of Pharmacology  
NYU Grossman School of Medicine 
Chief, Urology NYU Langone Health 
222 East 41st Street, 12th floor 
New York, NY 10017 
Email: Herbert.lepor@nyulangone.org 
Phone: 646-825-6340 
 
Additional Investigators: 
Samir S. Taneja, MD
William C. Huang, MD 
James Wysock, MD 
Angela Tong, MD 
Wei Phin Tan, MD 
 
NYU Grossman School of Medicine
Urology, NYU Langone Health
222 East 41st Street, 12th floor
New York, NY 10017
Phone: 646-280-7561
NYULMC Study Number: 
s22-00547     
Funding Sponsor:
Blue Earth Diagnostics, Inc.
 
25 Burlington Mall Road, Ste. 206 
Burlington, MA  01803 
(855) 298-6461 
IND/IDE Number: 
IND 163319
Study Product:
rhPSMA-7.3 (18F)
Study Product Provider:  
Blue Earth Diagnostics, Inc.
ClinicalTrials.gov 
Number                
NCT05678322 
 
Initial version: 12/08/2022 
Amended: 
[06/16/2023] 
Amended: 
[10/05/2023] 
Amended:           [05/20/2024] 
 
 
 Statement of Compliance 

Study number: s22-00547
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This study will be conducted in accordance with the Code of Federal Regulations on the Protection of 
Human Subjects (45 CFR Part 46), 21 CFR Parts 50, 56, 312, and 812 as applicable, any other applicable 
US government research regulations, and institutional research policies and procedures. The International 
Conference on Harmonization (“ICH”) Guideline for Good Clinical Practice (“GCP”) (sometimes referred to 
as “ICH-GCP” or “E6”) will be applied only to the extent that it is compatible with FDA and DHHS regulations. 
The Principal Investigator will assure that no deviation from, or changes to the protocol will take place 
without prior agreement from the funding sponsor and documented approval from the Institutional Review 
Board (IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. All 
personnel involved in the conduct of this study have completed Human Subjects Protection Training. 
 
 List of Abbreviations
 
 
AE 
Adverse Event/Adverse Experience
CFR
Code of Federal Regulations
CRF 
Case Report Form
CSOC 
Clinical Study Oversight Committee 
DCC
Data Coordinating Center
DHHS 
Department of Health and Human Services
DSMB 
Data and Safety Monitoring Board
FFR
Federal Financial Report
FWA 
Federal wide Assurance
GCP
Good Clinical Practice
HIPAA 
Health Insurance Portability and Accountability Act
ICF
Informed Consent Form
ICH 
International Conference on      Harmonization
IRB
Institutional Review Board
ISM
Independent Safety Monitor
MOP
Manual of Procedures
N 
Number (typically refers to participants)
NIH 
National Institutes of Health
OHRP 
Office for Human Research Protections
OHSR 
Office of Human Subjects Research
PI
Principal Investigator
QA
Quality Assurance
QC
Quality Control 
SAE
Serious Adverse Event/Serious Adverse Experience 
SOP
Standard Operating Procedure 
US 
United States

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BCR
Biochemical Recurrence
PET
Positon Emission Tomography
NYU  
New York University
RP
Radical Prostatectomy
GGG 
Gleason Grade Group
PSADT
PSA doubling time
BED
Blue Earth Diagnostics

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 Protocol Summary 
Title 
Optimizing timing of rhPSMA-7.3 (18F), for 
assessing site(s) of recurrent disease 
following Radical Prostatectomy      
 
Short Title 
rhPSMA-7.3 (18F) study 
Brief Summary 
 
All men following RP at NYU Langone Health 
undergo routine PSA testing in order to 
identify disease recurrence. By consensus, a 
BCR following RP occurs once the PSA > 0.2 
ng/ml/ Biochemical recurrence often develops 
years prior to clinical evidence of disease 
recurrence. Early identification of the site(s) of 
disease recurrence enables early salvage 
intervention. Men will be eligible for the study 
at the point in time their post-prostatectomy 
PSA level first becomes >0.2 ng/ml. Only 
those subjects with rhPSMA-7.3 (18F) 
identifiable disease (local, nodal or systemic) 
will be offered salvage intervention per our 
standard of care.  All subjects with a negative 
initial rhPSMA-7.3 (18F) scan will undergo a 
second scan when the PSA is > 0,5 ng/ml or 
one year after the initial PET study. The 
salvage interventions will be at the discretion 
of the investigator. The study will compare the 
diagnostic yield of the first and second 
rhPSMA-7.3 (18F) studies. 
Objectives 
The primary study objective is to evaluate 
the optimal timing for rhPSMA-7.3 (18F) PET 
imaging for detecting site(s) of disease 
recurrence following RP. 
The secondary objective: determine the 
disease characteristics that are associated 
with earliest Rh-PSMA detection of disease 
recurrence  
Methodology 
Open Label 

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Endpoint 
Primary Endpoint: Comparative diagnostic 
yield (focal, nodal or systemic disease 
recurrence) of rhPSMA-7.3 (18F) PET 
MRI in men with BCR following RP at 
two time points after PSA first becomes > 
0.2ng/ml. 
Secondary Endpoint: Factors associated 
with positive rhPSMA-7.3 (18F) study.
Study Duration 
This current study will be conducted for 
approximately 24 months   
Participant Duration 
24 months is the time it will take for each 
individual participant to complete all 
participant visits. 
Population 
All men undergoing RP at NYU Langone 
Health will be eligible at the first time the PSA 
>0.2ng/ml. 
Study Sites 
Department of Urology at NYU Langone 
Health 
Number of participants 
Number of participants projected for the entire 
study 26 
Description of Study Agent/Procedure 
rhPSMA-7.3 (18F) is a 18F-labeled PET 
diagnostic agent  FDA approved for the 
diagnosis of PCa. The molecular structure of 
the drug substance comprises a PSMA 
binding motif, a peptide spacer, an 18F-
radiolabeled silicon fluoride acceptor moiety 
and a gallium chelator complex. 
Key Procedures 
rhPSMA-7.3 (18F) PET MRI imaging 

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Statistical Analysis 
 
Subjects who test positive at Scan #1 and 
undergo salvage treatment will carry forward 
as a positive second scan which enables us to 
use a McNemar's test to compare paired 
results between Scan 1 and 2. 
We consider a clinically significant detection 
rate for 30 percentage points between Scan 1 
and 2. 
Assumptions: 
1. 20% of our participants will have a 
positive Scan #1  
o 
100% of these 20% will have 
a presumed positive Scan #2 
2. 80% of our participants will have a 
negative Scan #1  
o 
37.5% of these 80% will have 
a positive Scan #2 
o 
62.5% of these 80% will have 
a negative Scan #2  
At a power of 80% and alpha of 5%, we would 
need a sample size of 19 to be adequately 
powered to show a clinically significant 
change in detection rates. Thus, a sample of 
26 allows for some drop-out or failure to 
follow-up without compromising the study. 
With a sample size of 26, if we have no drop-
outs, at a power of 80% and an alpha of 5%, 
we are adequately powered to detect a 
change from 20% positive between Scan 1 
and 2. 

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Schematic of Study Design 

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1 
Key Roles 
 
The Principal Investigator  
Herbert Lepor, MD 
Professor and Martin Spatz Chair of Urology  
Professor of Pharmacology  
NYU Grossman School of Medicine 
Chief, Urology NYU Langone Health 
222 East 41st Street, 12th floor 
New York, NY 10017 
646-825-6340 
Herbert.lepor@nyulangone.org 
 
Co-Investigator 
Samir S. Taneja, MD 
Director, GU Oncology Program, NYU Perlmutter Cancer Center 
Vice-Chair, Department of Urology 
Department of Urology 
New York University Grossman School of Medicine 
NYU Langone Health 
222 E. 41st Street, 12th Floor 
New York, New York   10017 
646-825-6321 
Samir.Taneja@nyulangone.org 
 
 
 
Co-Investigator 
William C. Huang, MD 
Professor of Urology and Radiology 
NYU Grossman School of Medicine 
222 East 41st street, 12th floor,  
New York, NY, 10017 
 646 744 1503  
William.huang@nyulangone.org  
 
Co-Investigator 
James Wysock, MD 
New York University School of Medicine  
Department of Urology 
222 East 41st St 12th floor  
New York, NY, 10017 
646-280-7561 
James.Wysock@nyulangone.org 
 
Co-Investigator 
Wei Phin Tan, MD 
Urologic Oncology 
Assistant Professor of Urology 
NYU Urology Associates 
NYU Langone Health 
222 East 41st St 12th floor  
New York, NY, 10017 
646-825-6300 
WeiPhin.Tan@nyulangone.org 
 
 
 
 
 
 
 
 
 
 
 
 

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2 
Introduction, Background Information and Scientific Rationale 
 
2.1 
Background Information and Relevant Literature 
 
Approximately 20% of men undergoing radical prostatectomy (RP) will develop biochemical disease recurrence (BCR) defined as 
PSA > 0.2 ng/ml within 10 years of surgical intervention (Ref.1) The challenge is to determine if the site(s) of disease is local, nodal 
or systemic. Knowing the site(s) of disease influences salvage management. Historically, imaging studies used to identify sites of 
disease recurrence imaging CT or MRI and bone scintigraphy. Unfortunately, these studies lacked both sensitivity and specificity for 
identifying site(s) of metastasis at the time BCR first detected (Ref.2) PET MRI imaging using various commercially available ligands 
has been shown to be more sensitive than standard imaging for detecting site(s) of recurrent disease at lower levels of PSA. 
Following radical prostatectomy (Ref.3).  Early identification of the sites of disease recurrence would inform whether to offer salvage 
radiation or androgen deprivation therapy. rhPSMA-7.3 (18F), is a new ligand being developed for detecting recurrent disease 
following RP (Ref.4) The lower limit of sensitivity for detecting disease recurrence following RP has not been elucidated. PET 
imaging is costly and a negative scan provides patient anxiety since treatment decisions are often deferred. The rationale for the 
present study is to define the sensitivity of rhPSMA-7.3 (18F), imaging at the earliest time point following development of BCR 
following RP. This objective will be explored by obtaining a rhPSMA-7.3 (18F), test  soon at a BCR > 0.2ng/ml If the scan is non-
diagnostic, no treatment will be offered and a second scan will be performed when the PSA is >0.5 ng/ml or one year after the 
detection of BCR. 
2.2 
Name and Description of the Investigational Agent  
rhPSMA-7.3 (18F) is a 18F-labeled PET diagnostic agent FDA approved  for the diagnosis of PCa. The molecular structure of the 
drug substance comprises a PSMA binding motif, a peptide spacer, an 18F-radiolabeled silicon fluoride acceptor moiety and a 
gallium chelator complex. 
 
2.2.1 
Preclinical and Clinical Data to Date 
As rhPSMA-7.3 (18F) represents approximately 39% of rhPSMA-7 (18F), initial clinical data from a retrospective study of 1189 patients 
who underwent rhPSMA-7 (18F) PET scans are relevant to the understanding of rhPSMA-7.3 (18F) (Study BED-PSMA-402). Based 
on these data, it was concluded that use of moderate activities >8 to 10 mCi (>297 to 370 MBq) at an early imaging time point (50 to 
70 minutes) is likely preferable for rhPSMA-7 (18F) in general use. However, the most abundant diastereoisomer in the rhPSMA-7 
(18F) mixture, rhPSMA-7.3 (18F), appears to have slightly higher tumor uptake compared to the other isomers. Although initial clinical 
use involved rhPSMA-7 (18F) diastereoisomeric mixture, rhPSMA-7.3 (18F) has been taken into future development as a single isomer 
(Studies BED-PSMA-403, BED-PSMA-101, BED-PSMA-301 and BED-PSMA-302) and the recommended activity may differ from the 
data generated on rhPSMA-7 (18F). 

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2.2.2 
Dose Rationale (if applicable)  
Defining the performance of rhPSMA-7.3 (18F) at different PSA levels thresholds is the primary objective of the present study. 
2.3 
 Rationale 
Optimal management of disease recurrence following RP requires identification of the site(s) of disease. PET MRI imaging is the 
most sensitive imaging modality for identifying site(s) of disease recurrence following RP. Elucidating the sensitivity of PET MRI 
imaging will inform the optimal time to initiate assessment for recurrent disease. Since BCR following RP is defined by a PSA >0.2 
ng/ml, the first rhPSMA-7.3 PET MRI in the present study will be performed as soon as BCR is detected. If the rhPSMA-7.3 PET MRI 
fails to identify site(s) of disease recurrence then no treatment will be offered and a second scan will be performed when the PSA is > 
0.5 ng/ml or one year after designation of BCR. 
Our hypothesis is that the diagnostic yield when BCR is first designated by a PSA > 0.2 ng/ml is too low to justify routine testing.  We 
anticipate a significantly higher diagnostic yield when the PSA is >0.5 ng/ml or one year after initial imaging. 
2.4 
Potential Risks & Benefits 
2.4.1 
Known Potential Risks 
One minor risk is related to a single venipuncture to inject the rhPSMA-7.3 (18F). Participants undergoing 1 scan will be exposed to 
4.7 mSv (0.47 rem) radiation. The participants who will undergo two scans will be exposed to approximately 9.4 mSv .0.94 rem) of 
radiation, equivalent to the amount of radiation received from the natural radiation background environment over a period of about 3 
years. rhPSMA-7.3 (18F).  
 
MRI associated risks: 
  Magnetic resonance imaging or MRI scanning uses magnetism, radio waves, and a computer to produce images of body 
structure 
  MRI scanning is painless and does not involve x-ray radiation. 
 Patients with heart pacemakers, metal implants, or metal chips or clips in or around the eyes cannot be scanned with MRI 
because of the effect of the magnet. 
 Claustrophobic sensation can occur with MRI scanning 
 Privacy protection procedures are in place and good clinical practice guidelines are followed for the study to minimize risks 
associated with research procedures and participation. 
2.4.2 
Known Potential Benefits 
Not all insurance providers will pay for the PET component of MRI imaging in order to detect disease recurrence following RP. The 
potential benefit to the patient is earlier identification of  the site(s) of disease following RP which enables early intervention. 
 

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3 Objectives and Purpose 
3.1 
Primary Objective 
The primary study objective is to evaluate the optimal timing for Rh-PSMA-7.3 PET imaging for detecting site(s) of disease recurrence 
following RP should be performed at a PSA of 0.2 ng/ml vs 0.5 ng/ml.  
3.2 Secondary Objective  
Determine the disease characteristics that are associated with Rh-PSMA-7.3 detection of disease recurrence.  
 
4 Study Design and Endpoints 
4.1 Description of Study Design 
All men undergoing RP at NYU Langone Health undergo routine PSA testing in order to identify disease recurrence. By consensus, a 
BCR following RP occurs once the PSA.0.2ng/ml. Biochemical recurrence develops years prior to clinical evidence of disease 
recurrence. Early identification of the site (s) of disease recurrence enables early salvage intervention. Men will be eligible for the 
study when their post-prostatectomy PSA level is initially observed to be PSA >0.2ng/ml. Only those subjects with rhPSMA-7.3 (18F) 
identifiable disease will be offered salvage intervention per our standard of care. All subjects with a negative initial rhPSMA-7.3 (18F) 
scan will undergo a second scan when the PSA> 0.5 ng/ml or one year after the initial PET study. The salvage intervention will be at 
the discretion of the investigator. The study will compare the performance of rhPSMA-7.3 (18F) at different and specified time points. 
Gleason grade group, (GGG), pathological stage, margin status, PSA doubling time (PSADT) will be compared between those 
subjects with a positive vs negative rhPSMA-7.3 (18F) scan. 
4.2 Study Endpoints 
4.2.1 
Primary Study Endpoints 
Performance of rhPSMA-7.3 (18F) MRI in men with BCR following RP between scan 1 (onset of BCR) and scan 2 (PSA > 0.5 ng/ml or 
one year after scan 1). 
4.2.2 
Secondary Study Endpoints 
The secondary endpoint is to elucidate those factors associated with a positive rhPSMA-7.3 (18F) scan. 
 

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5 Study Enrollment and Withdrawal 
5.1 Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
 
Eligible subjects will include all men between age 18 -100 years old,-that have had RP, at the first point in time the PSA > 0.2 ng/ml. 
Reasons for Withdrawal or Termination.  
Participants are free to withdraw from participation in the study at any time upon request. An investigator may terminate participation 
in the study if: 
 The participant meets an exclusion criterion (either newly developed or not previously recognized) that precludes further 
study participation. 
  
 If subject is unable to tolerate the rhPSMA-7.3 (18F) PET /MRI scan.  
  
 The subject’s insurance company denies pre-authorization for payment of a post radical prostatectomy MRI which is 
standard of care. 
 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
 Eligible subjects will include all men undergoing RP at the first point in time the PSA > 0.2 ng/ml. 
 Consented to undergo rhPSMA-7.3 (18F) PET/MRI following the protocol requirements.  
 
5.2 Exclusion Criteria 
 
An individual who meets any of the following criteria will be excluded from participation in this study: 
 Any contraindication for MRI imaging. 
 Prior allergic reaction to rhPSMA-7.3 (18F). 
 Patient refuses rhPSMA-7.3 (18F) PET/MRI. 

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5.4 Strategies for Recruitment and Retention 
 
Potential subjects will be identified from the co-investigators clinical practices at NYU Langone Health. The patients are being 
followed periodically for their PSA levels, and at the first point in time their PSA > 0.2 ng/ml they will be invited to participate in our 
study.  
Men undergoing RP are routinely followed for biochemical recurrence as standard of care. The PI and co-investigators will identify 
potential candidates when the PSA initially is >0.2ng/ml. At this time point, it is also standard of care (SOC) to obtain an abdominal 
/pelvic and prostate MRI to identify site (s) of disease recurrence. The research PET scan will be performed in addition to the SOC 
MRI, at the same time. 
Men following RP whose PSA increases > 0.2ng/ml will be eligible for the study. All men meeting this PSA threshold and interested 
participants will be invited to enroll in the clinical study. The research coordinator will explain the study to the participant and answer 
any questions that may arise during the discussion. All potential risks will be discussed with the participant. The rhPSMA-7.3 (18F) 
PET/MRI scan will be performed only after obtaining the participant’s signature on the informed consent form. 
We anticipate screening 3 patients a month who initially develop BCR following RP, of which two will enroll in the study. We 
anticipate enrolling 26 subjects over a twelve-month interval. The justification for the sample size is included in the statistical analysis 
section (Section 9). 
 
5.5 Duration of Study Participation 
 
We anticipate the 26 subjects to be enrolled within one year of study initiation. The first rhPSMA-7.3 (18F) imaging study will be 
obtained  within a month of enrollment. The second rhPSMA-7.3 (18F) imaging study will be performed within a year of the initial 
study. The total duration of the study should be 24 months.  
 
5.6 Total Number of Participants and Sites  
 
All participating subjects will be drawn by patients actively followed by the PI and co-investigators at NYU Langone Urology Faculty 
Group Practice. 
 
This is a single site study. Recruitment will end when 26 participants are enrolled. It is expected that approximately 26 participants 
will be enrolled to produce 19 evaluable participants. 
 

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5.7 Participant Withdrawal or Termination 
5.7.1 Reasons for Withdrawal or Termination, and Handling of Participant Withdrawals or Termination  
 
Participants are free to withdraw from participation in the study at any time upon request. An investigator may terminate 
participation in the study if: 
 
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation occurs such that continued 
participation in the study would not be in the best interest of the participant  
 
The participant meets an exclusion criterion (either newly developed or not previously recognized) that precludes further study 
participation 
If subject is unable to tolerate the rhPSMA-7.3 (18F) PET /MRI study 
The subject’s insurance company denies pre-authorization for payment of MRI and diagnostic biopsy. 
 
Participants are free to withdraw from participation in the study at any time upon request. An investigator may terminate participation 
in the study if: 
 Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation occurs such that continued 
participation in the study would not be in the best interest of the participant 
 The participant meets an exclusion criterion (either newly developed or not previously recognized) that precludes further 
study participation 
5.8 Premature Termination or Suspension of Study 
 
This study may be temporarily suspended or prematurely terminated 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 funding 
sponsor Blue Earth Diagnostic Ltd., and regulatory authorities. If the study is prematurely terminated or suspended, the PI will 
promptly inform the 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 
 Determination of futility 
 

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Study may resume once concerns about safety, protocol compliance, data quality are addressed and satisfy the sponsor, IRB and/or 
FDA. 
 
6
Study Agent (Study drug) and/or Procedural Intervention 
6.1 Study Agent(s) and Control Description 
 
rhPSMA-7.3 (18F) is a 18F-labeled PET diagnostic agent FDA approved for the diagnosis of PCa. The molecular structure of the drug 
substance comprises a PSMA binding motif, a peptide spacer, an 18F-radiolabeled silicon fluoride acceptor moiety and a gallium 
chelator complex. The significant over-expression of PSMA in the majority of PCa cells makes it an excellent target for imaging in PCa. 
Expression of PSMA is higher in more advanced stages of PCa and correlates with Gleason score and PSA concentrations (Ref.5). 
This increased expression of PSMA is less evident in prostatic hyperplasia (Ref.6). rhPSMA-7.3 (18F) is a sterile, aqueous solution for 
intravenous administration. 
6.1.1 Acquisition 
The study agent, rhPSMA-7.3 (18F) will be provided by Blue Earth Diagnostics Ltd. It will be shipped directly to the Isotope Radiology 
department at NYU Langone Health, where it will be administered to the research subject. 
6.1.2 Formulation, Appearance, Packaging, Labeling, Product Storage, and Stability 
From the end of synthesis, the shelf-life of rhPSMA-7.3 (18F) injection is 6 hours for the formulation used in Phase 1, and 10 hours 
for the formulation used in the ongoing Phase 3 studies. The product must not be used beyond these limits. rhPSMA-7.3 (18F) 
injection should be stored at room temperature in a shielded container. All non-radioactive containers (shielding, transport cans) must 
be returned to the manufacturing site. Containers that are radioactive or that contained radioactive products must be disposed of at 
either the study site or another designated facility, with prior approval from the sponsor, after the study and after overall drug 
accountability has been completed by the sponsor or its representative. 
Waste must be disposed of according to Federal, State, and local regulations for radioactive material. Precautions for the safe 
handling of radioactive materials should be observed. 
6.1.3 Dosing and Administration 
The mean effective dose for men per unit-administered activity was 0.0138 mSv/MBq using a 1-hour voiding interval and 0.0141 
mSv/MBq using a 3.5-hour voiding interval. Biodistribution data derived from the healthy volunteers in Study BED-PSMA-101 
suggest 8 – 10 mCi (296 – 370 MBq) would result in an image of diagnostic quality. 
 

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6.1.4 Route of Administration, and Duration of Therapy 
rhPSMA-7.3 (18F)  will be administered intravenously. And it is a single dose injection. 
7 Study Procedures and Schedule 
7.1 Study Procedures/Evaluations 
7.1.1 Study Specific Procedures
 Identification of eligible subjects by the PI and Co-PI’s 
 Explanation of study objectives and design 
 Informed consent 
 Comparing the diagnostic yield for detection of site (s) of disease recurrence following RP using an investigational rhPSMA-7.3 
MRI at two designated time points 
 Assessing any adverse effects of the RhPSMA ligand 
 
7.1.2 Standard of Care Study Procedures 
All decisions related to management of prostate cancer and its recurrence will be standard of care 
 
7.2 Study Schedule 
7.2.1 
Screening  and Enrollment  
 
All men at the first time point the BCR is observed following RP (PSA)0.2ng/ml) are eligible for enrollment in the study.  
The study coordinator will discuss all aspects of the protocol with the eligible subjects.  
Obtaining informed consent. 
Schedule rhPSMA-7.3 (18F) for participants who sign informed consent. 
      
7.2.2 
Enrollment/Baseline 
Enrollment/Baseline Visit Vital sign measurement before and after injection of the radiotracer is performed. 
The rhPSMA-7.3 (18F) PET imaging scan #1 is performed. 
Assessment of any possible AE, related with the rhPSMA-7.3 (18F) administration. 
Men with positive scans undergo salvage treatment, as per standard of care. 
 

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7.2.3 
Final Study Visit 
Vital sign measurement before and after injection of the radiotracer is performed. 
Conduct the second rhPSMA-7.3 (18F) PET imaging scan for subjects with negative rhPSMA-7.3 (18F) PET/MRI in the first scan. 
The second scan will be one year from the first scan, or when the PSA > 0.5 ng/ml. 
Assessment of any possible AE, related with the rhPSMA-7.3 (18F). Subjects will complete an AE form after completing the rhPSMA-
7.3 (18F) scan. 
 
8    Assessment of Safety, Adverse Events, Serious Adverse Events 
8.1 Classification of an Adverse Event, and Expectedness 
The Principal Investigator and/or co-investigators   will be responsible for determining whether an AE is expected or unexpected. An 
AE will be considered unexpected if the nature, severity, or frequency of the event is not consistent with the risk information 
previously described for the study agent. 
 
8.2 Reporting Procedures – Notifying the IRB . 
8.2.1 Adverse Event (AE) Reporting 
The risks associated with this study are low and infrequent, Herbert Lepor, M.D. the PI for the study, will be responsible for monitoring 
the safety of the study. The subjects will be instructed to report any side effect of the rhPSMA-7.3 (18F) in the Adverse Events form 
that will be provided to them on the day of the rhPSMA-7.3 (18F) PET MRI scan. The research coordinator will be the contact person 
who will receive the AE information.  
 
8.2.2 Serious Adverse Event (SAE) Reporting 
The risks associated with this study are low and infrequent, Herbert Lepor, M.D. the PI for the study, will be responsible for 
monitoring the safety of the study. The subjects will be instructed to report any side effect of the rhPSMA-7.3 (18F) in the AE form 
that will be provided to them on the day of the rhPSMA-7.3 (18F) PET MRI scan. The research coordinator will be the contact person 
who will receive the AES information. In addition to reporting of Serious Adverse Events (SAEs) to the responsible IRB/IEC and 
Health Authority, Principal Investigator or designee will inform Blue Earth Diagnostics (BED) of all SAEs in connection with the Study 
that occur following receipt of rhPSMA-7.3, whether or not related to Product.  
 

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PI or designee shall notify BED within twenty four (24) hours of knowledge of any SAEs.  SAE reports to BED must be recorded and 
faxed or scanned and emailed to:  
 
Bracco Diagnostics Inc. Drug Safety Unit  
E mail:  Drugsafetyus@BlueEarthDx.com   
Fax:   +1-609-514-2522 
 
To the extent permitted by federal law, additional and further requested information (follow-up or corrections to the original case) will 
be detailed and faxed/emailed to the same address and will include the following minimum information: The name and contact 
information of the reporter, the name of the study drug(s), a description of the reported SAE, with the patient identified by one or 
more of the following (patient initials/code, patient number  age, sex), an investigator assessment of study drug causality, and any 
additional data customarily accompanying such reports which would aid the review and causality assessment of the case including 
but not limited to the date of onset, severity, the time from administration of study drug(s) to start of the event, the duration and 
outcome of the event, any possible etiology for the event, and the final diagnosis or syndrome, if known. 
8.2.3 Unanticipated Problem Reporting 
 
Incidents or events that meet the OHRP criteria for UPs require the creation and completion of an UP report form. It is the site 
investigator’s responsibility to report UPs to their IRB and to the study sponsor. The UP report will include the following information: 
 
 Protocol identifying information: protocol title and number, PI’s name, and the IRB project number; 
 A detailed description of the event, incident, experience, or outcome; 
 An explanation of the basis for determining that the event, incident, experience, or outcome represents an UP; 
 A description of any changes to the protocol or other corrective actions that have been taken or are proposed in response to 
the UP. 
 
As BED continues to develop this compound, we recommend that the safety monitoring period can be suitably within 24 hours of 
injection, while acknowledging it is the sponsor’s decision. 
 
83 Reporting Procedures – Notifying the FDA  
 
The study sponsor is required to report certain study events in an expedited fashion to the FDA.  These written notifications of 
adverse events are referred to as INDsafety reports.  
 
The following describes the IND safety reporting requirements by timeline for reporting and associated type of event: 
 

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 Within 7 calendar days (via telephone or facsimile report) 
Any study event that is: 
– associated with the use of the study drug 
– unexpected,  
– fatal or life-threatening 
 
 Within 15 calendar days (via written report) 
Any study event that is: 
– associated with the use of the study drug, 
– unexpected, and 
– serious, but not fatal or life-threatening 
-or- 
– a previous adverse event that was not initially deemed reportable but is later found to fit the criteria for reporting (reporting 
within 15 calendar days from when event was deemed reportable). 
Any finding from tests in laboratory animals that:  
– suggest a significant risk for human subjects including reports of mutagenicity, teratogenicity, or carcinogenicity. 
 
 
 
Additional reporting requirements 
Sponsors are also required to identify in IND safety reports all previous reports concerning similar adverse events and to analyze the 
significance of the current event in light of the previous reports. 
 
8.4 Safety Oversight 
 
It is the responsibility of the Principal Investigator to oversee the safety of the study at his site.  This safety monitoring will include 
careful assessment and appropriate reporting of adverse events as noted above, as well as the construction and implementation of a 
site data and safety-monitoring plan. Medical monitoring will include a regular assessment of the number and type of serious adverse 
events. Safety oversight will be under the direction of the PI. He will complete a DSM report about the safety and efficacy data 
semiannually. 
9 Statistical Considerations, Hypothesis, and Sample Size 
. 
The primary study objective is to evaluate whether the first Rh-PSMA-7.3 PET imaging study for detecting site(s) of disease recurrence following RP 
should be performed at a PSA of 0.2 ng/ml vs 0.5 ng/ml.  

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Subjects who test positive at scan # 1, and undergo salvage treatment will carry forward as a positive second scan which enables us 
to  use a McNemar's test to compare paired results between scan 1 and 2.  
 
We consider a clinically significant detection increase to represent of 30 percentage points between scan 1 and 2 , from 20% positive 
at PSA 0.2 ng/ml to 50% positive at PSA 0.5 ng/ml: 
 Assumptions: 
 20% of our participants will have a positive scan 1  
 100% of these 20% will have a presumed positive scan 2. 
 80% of our participants will have a negative at scan 1. 
 37.5% of these 80% will switch to positive scan 2. 
 62.5% of these 80% will remain negative a scan 2. 
 
At a power of 80% and alpha of 5%, we would need a sample size of 19 to be adequately powered to show a clinically significant 
change in detection rates.  Thus, a sample of 26 would allow for some drop-out or failure to follow-up without compromising the 
study. With a sample size of 26, if we have no drop-outs, at a power of 80% and an alpha of 5%, we are adequately powered to 
detect a change from 20% positive between scan 1 and 2. 
 
10 Source Documents and Access to Source Data/Documents 
 
Access to study records will be limited to IRB-approved members of the study team. The investigator will permit study-related 
monitoring, audits, and inspections by the IRB/EC, the sponsor, government regulatory bodies, and University compliance and 
quality assurance groups of all study related documents (e.g. source documents, regulatory documents, data collection instruments, 
study data etc.).  The investigator will ensure the capability for inspections of applicable study-related facilities (e.g. pharmacy, 
diagnostic laboratory, etc.). 
 
11 Quality Assurance and Quality Control 
 
QC procedures will be implemented beginning with the data entry system and data QC checks that will be run on the database will 
be generated. Any missing data or data anomalies will be communicated to the site(s) for clarification/resolution. 
 
Following written SOPs, the monitors will verify that the clinical trial is conducted and data are generated, documented (recorded), 
and reported in compliance with the protocol, GCP, and the applicable regulatory requirements (e.g., Good Laboratory Practices 
(GLP), Good Manufacturing Practices (GMP)). 
 

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The investigational site will provide direct access to all trial related sites, source data/documents, and reports for the purpose of 
monitoring and auditing by the sponsor, and inspection by local and regulatory authorities. 
 
12 Ethics/Protection of Human Subjects
12.1 Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with Regulations for the Protection of Human Subjects of 
Research codified in 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, and/or the ICH E6. 
12.2 Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the IRB for review and 
approval. Approval of both the protocol and the consent form must be obtained before any participant is enrolled. Any amendment to 
the protocol will require review and approval by the IRB before the changes are implemented to the study. All changes to the consent 
form will be IRB approved; a determination will be made regarding whether previously consented participants need to be re-
consented. 
12.3 Informed Consent Process 
Consent process will take place in the consult rooms, complete privacy will be provided. Consent forms describing in detail the study 
agent (rhPSMA-7.3 (18F)), study procedures, and risks are given to the participant and written documentation of informed consent is 
required prior to starting intervention/administering study product. All the eligible and interested participants will be given an informed 
consent form to read before being scheduled for an rhPSMA-7.3 (18F) PET MRI scan. The research coordinator will explain the 
study to the participant and answer any questions that may arise during the discussion. All potential risks will be discussed with the 
participant. The rhPSMA-7.3 (18F) PET MRI scan will be performed only after obtaining the participant’s signature on the informed 
consent form.  
 A copy of the signed informed consent document will be stored in the subject’s research record. The consent process, including the 
name of the individual obtaining consent, will be thoroughly documented in the subject’s research record. Any alteration to the 
standard consent process (e.g. use of a translator, , consent document presented orally, etc.) and the justification for such alteration 
will likewise be documented. 
12.4 Participant and Data Confidentiality 
 
Information about study subjects will be kept confidential and managed according to the requirements of the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA).   

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In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, will retain the ability to use all 
information collected prior to the revocation of subject authorization .Participant confidentiality will be strictly held in trust by the 
participating investigators, the research team. 
13 Data Handling and Record Keeping 
All the data that is collected for each participant will be included in the subject’s research file. The files will be kept at a secure 
location. Only the members of the research team will have access to the research files. TrialMaster is the software that will be used 
for all data collection. The electronic data will be secured with a password which will be known only to the members of the research 
team. 
13.1 Study Records Retention 
 
Study documents will be retained for the longer of 3 years after close-out, 5 years after final reporting/publication, or 2 years after the 
last approval of a marketing application is approved for the drug for the indication for which it is being investigated or 2 years after the 
investigation is discontinued and FDA is notified if no application is to be filed or if the application has not been approved for such 
indication. No records will be destroyed without the written consent of the sponsor, if applicable. It is the responsibility of the sponsor 
to inform the investigator when these documents no longer need to be retained. 
13.2 Protocol Deviations 
Protocol deviations or violations (includes intentional and accidental/unintentional deviations from the IRB approved protocol) for any 
of the following situations: 
- 
One or more participants were placed at increased risk of harm. 
- 
The event has the potential to occur again. 
- 
The deviation was necessary to protect a subject from immediate harm. 
 
Protocol deviations will be reported to the IRB no later than 5 working days after the event is discovered. 
 

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13.3 Publication and Data Sharing Policy 
The publication of an abstract, article or paper in a journal or an electronic repository, or its presentation at a conference or seminar; 
and in clause 8 to Publish and words to a similar effect are to be construed accordingly. 
 
14 Study Finances 
14.1 Funding Source 
Blue Earth Diagnostic Inc. is the company that manufactures rhPSMA-7.3 (18F). They will donate the rhPSMA-7.3 (18F). The 
rhPSMA-7.3 (18F) PET MRI adds approximately one hour to the imaging time.  
14.2 Costs to the Participant 
The standard of care includes a repeat PSA and MRI post radical prostatectomy. The patient will be responsible for the standard of 
care costs if these costs are denied by their insurance carrier. Pre-authorization will be obtained prior to performing the repeat MRI 
after radical prostatectomy. 
14.3  Participant Reimbursements or Payments 
Participants will not be reimbursed or get any payment for their participation in this study.  
 
15 Study Administration 
15.1 Study Leadership 
The PI for the study will be Herbert Lepor, MD who is Professor and Chair of Urology at NYU Grossman School of Medicine. Drs 
Samir Taneja, William Huang, James Wysock, and Wei Phin Tan all who are fellowship trained in urologic oncology, will serve as co-
PI.  They will request the rhPSMA-7.3 (18F) PET MRI scans. The PI or other co -PI’s interpret the MRI and determine if a second 
scan is necessary per protocol criteria. 
 
16 Conflict of Interest Policy 
The PI, nor the co-PI’s have any conflicts of interest with the sponsor of the study 

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17 References 
 
 
1. 
Llukani E, Lepor H. Aetiology and management of earlier vs later biochemical recurrence after retropubic radical 
prostatectomy”. BJU Int. 2017 Oct;120(4):505-510. 
2. 
Pasini E;Panagiotidis E;Zoglopitou LA;Kalathas T;Makridou A;Chatzipavlidou V; “Comparative Study of the Most Commonly-
Used Radiopharmaceuticals for PSMA Prostate PET/CT Imaging.” Hellenic Journal of Nuclear Medicine, U.S. National Library 
of Medicine, https://pubmed.ncbi.nlm.nih.gov/35388805/?fc=None&ff=20220408135503&v=2.17.6.  
3. 
Pasini E;Panagiotidis E;Zoglopitou LA;Kalathas T;Makridou A;Chatzipavlidou V; “Comparative Study of the Most Commonly-
Used Radiopharmaceuticals for PSMA Prostate PET/CT Imaging.” Hellenic Journal of Nuclear Medicine, U.S. National Library 
of Medicine, https://pubmed.ncbi.nlm.nih.gov/35388805/?fc=None&ff=20220408135503&v=2.17.6.  
4. 
 “Piflufolastat F 18: Diagnostic First Approval.” Figshare, Adis Journals, 18 July 2021, 
https://adisjournals.figshare.com/articles/online_resource/Piflufolastat_F_18_Diagnostic_First_Approval/14955735. 
5. 
Mannweiler S;Amersdorfer P;Trajanoski S;Terrett JA;King D;Mehes G; “Heterogeneity of Prostate-Specific Membrane 
Antigen (PSMA) Expression in Prostate Carcinoma with Distant Metastasis.” Pathology Oncology Research : POR, U.S. 
National Library of Medicine, https://pubmed.ncbi.nlm.nih.gov/18802790/.  
6. 
Birtle AJ;Freeman A;Masters JR;Payne HA;Harland SJ; ; “Tumour Markers for Managing Men Who Present with Metastatic 
Prostate Cancer and Serum Prostate-Specific Antigen Levels Of.” BJU International, U.S. National Library of Medicine, 
https://pubmed.ncbi.nlm.nih.gov/16042718/.  
 
 
 
 
 
 
 
 
 
 
 
19 Schedule of Events 
 

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Activity 
Visit 1 
 
Visit 2 
rhPSMA-7.3 (18F) PET/MRI scan #1 
When PSA 0.2 ng/ml following RP 
Visit 3 
rhPSMA-7.3 (18F) PET/MRI scan #2 
12 Mo from rhPSMA-7.3 (18F) scan #1, or when 
PSA>0.5 ng/ml 
Study team procedures 
  
  
  
Confirming eligibility 
x 
 
 
Study review with possible participant 
x 
 
 
Informed consent 
x 
 
 
Vital sign measurement before injection of the 
radiotracer 
 
x 
x 
Study drug/device dispensation  
 
x 
x 
Vital sign measurement after injection of the 
radiotracer 
 
x 
x 
Participant study ligand Adverse Events survey 
 
x 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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