Conditions: Prostate Cancer Prostate Cancer Metastatic
Keywords: PET/CT prostate cancer Gallium-68 PSMA-11
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief summary:
To goal of this research is to assess the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to increase diagnostic accuracy in localizing primary and metastatic lesions in patients with suspected prostate cancer and elevated Prostate Imaging Reporting and Data System (PI-RADS) scores and Prostate-Specific Antigen (PSA).

Detailed description:
This study is designed to evaluate the added value of 68Ga PSMA-11 PET/CT for detection of additional primary prostate cancer lesions compared to multiparametric magnetic resonance imaging (mpMRI) in a group of patients with elevated PI-RADS scores and PSA. We propose that the addition of early dynamic 68Ga PSMA-11 PET/CT imaging to the more usual delayed imaging will enhance detection of primary lesions and additional lesions not detected on the mpMRI. In addition, the dynamic imaging will allow us to evaluate the kinetics of uptake in the prostate gland. It is possible that even in the absence of focal uptake, hyperemia of the gland could indicate the presence of an occult primary.

A second purpose of this research is to examine the value of 68Ga PSMA-11 PET/CT in this same group of patients in detecting metastatic disease at initial staging in comparison with current standard of care imaging such as computed tomography (CT) and magnetic resonance imaging (MRI).

Arms:
arm 1: Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy

Interventions: intervention 1: 68Ga PSMA-11 injection intervention 2: Positron Emission Tomography/Computed Tomography
Intervention descriptions: intervention 1: Injection of 68Ga PSMA-11 intervention 2: PET/CT scan after 68Ga PSMA-11 injection

Protocol document:
Prot_SAP_000.pdf: 
 
Primary PSMA Protocol - 3.10.2021 
 
 
 
CONFIDENTIAL 
This material is the property of the UTSW Simmons Comprehensive Cancer Center.  
Do not disclose or use except as authorized in writing by the study sponsor. 
 
Template Updated: 12/2012; 9/2013; 8/2014; 4/2015; 10/2015; 11/2016, 12/2018 
STU-2019-1198 
The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate 
Cancer 
 
Principal Investigator:  
Neil Rofsky MD  
 
 
 
 
UT Southwestern Medical Center 
 
 
 
 
Address: 5323 Harry Hines Blvd, Dallas, TX, 75390 
 
 
 
 
(Phone): (214) 648-7702 
 
 
 
 
(Fax): (214) 648-7782 
 
 
 
 
Email: Neil.rofsky@utsouthwestern.edu 
 
Lead Sub-Investigator(s): 
Daniella Pinho MD 
 
 
 
 
UT Southwestern Medical Center 
 
 
 
 
Department of Radiology 
 
 
 
 
Address: 5323 Harry Hines Blvd, Dallas TX 75390-9316 
 
 
 
 
(Phone): 214-648-7776 
 
 
 
 
(Fax): 214-645-2762 
 
 
 
 
Email: Daniella.pinho@utsouthwestern.edu 
 
 
 
 
 
Daniel Costa MD 
 
 
 
 
UT Southwestern Medical Center 
 
 
 
 
Department of Radiology 
 
 
 
 
Address: 5323 Harry Hines Blvd, Dallas TX 75390-9085 
 
 
 
 
(Phone): 214-645-2704 
 
 
 
 
(Fax): 214-645-2762 
 
 
 
 
Email: Daniel.costa@utsouthwestern.edu 
 
Biostatistician: 
 
Yin Xi 
 
 
 
 
UT Southwestern Medical Center 
 
 
 
 
Address: 5323 Harry Hines Blvd. Dallas, TX 75390-9061 
 
 
 
 
(Phone): 214-648-7755 
 
 
 
 
(Fax): 214-648-7784 
 
 
 
 
Email: yin.xi@utsouthwestern.edu 
 
Study Drug/Treatment: 
68Ga Prostate Specific Angtigen-11 
 
IND/IDE Number: 
 
144777 
 
IND/IDE Holder Name:  
Dana Mathews Ph.D., M.D. 
 
Funding Source:  
Radiology Department Funds 
 
Initial version: 
1.0 – June 2019 
 
Amended: 
 
 3.0 – March 2021 
 
 
UT Southwestern Medical Center (UTSW) 
Harold C. Simmons Comprehensive Cancer Center 
Attn: Clinical Research Office 
5323 Harry Hines Blvd. MC 9179 
Dallas, Texas 75390-9179 
 


 
Primary PSMA Protocol - 3.10.2021 
 
 
 
CONFIDENTIAL 
This material is the property of the UTSW Simmons Comprehensive Cancer Center.  
Do not disclose or use except as authorized in writing by the study sponsor. 
 
Template Updated: 12/2012; 9/2013; 8/2014; 4/2015; 10/2015; 11/2016, 12/2018 
 
Signature Page 
 
 
The signature below constitutes the approval of this protocol and the attachments, and provides the 
necessary assurances that this trial will be conducted according to all stipulations of the protocol, including 
all statements regarding confidentiality, and according to local legal and regulatory requirements and 
applicable U.S. federal regulations and ICH guidelines. 
 
Amendment/Version # 3 
STU-2019-1198 
The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate  
 
 
Principal Investigator (PI) Name: Neil Rofsky, MD 
 
 
 
PI Signature: _____________________________ 
 
 
 
Date: ____________________ 
 


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TABLE OF CONTENTS 
LIST OF ABBREVIATIONS ...........................................................................................1 
STUDY SCHEMA .............................................................................................................2 
STUDY SUMMARY ..........................................................................................................3 
1.0.......................................................................... BACKGROUND AND RATIONALE
..............................................................................................................................................4 
1.1 
Disease Background........................................................................................................ 4 
1.2 
Study Agent(s)/Therapy(ies) Background and Associated Known Toxicities ................. 4 
1.3 
Other Agents .................................................................................................................... 5 
1.4 
Rationale .......................................................................................................................... 5 
1.5 
Correlative Studies .......................................................................................................... 5 
2.0................................................................................................... STUDY OBJECTIVES
..............................................................................................................................................5 
2.1 
Primary Objectives ........................................................................................................... 5 
2.2 
Secondary Objectives ...................................................................................................... 5 
2.3 
Exploratory Objectives ..................................................................................................... 5 
2.4 
Endpoints ......................................................................................................................... 6 
3.0.............................................................................................. PATIENT ELIGIBILITY
..............................................................................................................................................5 
3.1 
Inclusion Criteria .............................................................................................................. 6 
3.2 
Exclusion Criteria ............................................................................................................. 6 
4.0..................................................................................................... TREATMENT PLAN
..............................................................................................................................................7 
4.1 
Treatment Dosage and Administration ............................ Error! Bookmark not defined. 
4.2 
Toxicities and Dosing Delays/Dose Modifications ........... Error! Bookmark not defined. 


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4.3 
Concomitant Medications/Treatments ............................................................................. 7 
4.4 
Other Modalities or Procedures ....................................................................................... 8 
4.5 
Duration of Therapy ......................................................... Error! Bookmark not defined. 
4.6 
Duration of Follow Up ...................................................................................................... 8 
4.7 
Removal of Patients from Protocol Therapy .................................................................... 8 
4.8 
Patient Replacement ....................................................................................................... 8 
5.0................................................................................................ STUDY PROCEDURES
..............................................................................................................................................8 
5.1 
Screening/Baseline Procedures ...................................................................................... 8 
5.2 
Procedures During Treatment ......................................................................................... 9 
5.3 
Follow-up Procedures ...................................................................................................... 9 
5.4 
Time and Events Table .................................................................................................. 10 
5.5 
Removal of Subjects from Study ................................................................................... 10 
6.0................................................................................... MEASUREMENT OF EFFECT
............................................................................................................................................10 
6.1 
Antitumor Effect- Solid Tumors ........................................ Error! Bookmark not defined. 
6.2 
Antitumor Effect- Hematologic Tumors ............................ Error! Bookmark not defined. 
6.3 
Safety/Tolerability .......................................................................................................... 11 
7.0...................................................................................................... ADVERSE EVENTS
............................................................................................................................................11 
7.1 
Experimental Therapy.................................................................................................... 11 
7.2 
Adverse Event Monitoring ............................................................................................. 11 
7.3 
Steps to Determine If an Adverse Event Requires Expedited Reporting ...................... 21 
7.4 
Unblinding Procedures .................................................................................................. 23 
7.5 
Stopping Rules .............................................................................................................. 23 
8.0..................................................................... DRUG/TREATMENT INFORMATION
............................................................................................................................................23 


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8.1 
Agent/Treatment {68Ga PSMA-11} ............................................................................... 23 
9.0...................................................................... CORRELATIVES/SPECIAL STUDIES
............................................................................................................................................25 
9.1 
Sample Collection Guidelines .......................................... Error! Bookmark not defined. 
9.2 
Assay Methodology ......................................................... Error! Bookmark not defined. 
9.3 
Specimen Banking ........................................................... Error! Bookmark not defined. 
10.0........................................................................ STATISTICAL CONSIDERATIONS
............................................................................................................................................16 
10.1 
Study Design/Study Endpoints ...................................................................................... 17 
10.2 
Sample Size and Accrual .............................................................................................. 17 
10.3 
Data Analyses Plans...................................................................................................... 17 
11.0............................................................................................ STUDY MANAGEMENT
............................................................................................................................................26 
11.1 
Conflict of Interest .......................................................................................................... 17 
11.2 
Institutional Review Board (IRB) Approval and Consent ............................................... 18 
11.3 
Required Documentation ............................................................................................... 18 
11.4 
Registration Procedures ................................................................................................ 18 
11.5 
Data Management and Monitoring/Auditing .................................................................. 18 
11.6 
Adherence to the Protocol ............................................................................................. 19 
11.7 
Amendments to the Protocol ......................................................................................... 20 
11.8 
Record Retention ........................................................................................................... 20 
11.9 
Obligations of Investigators ........................................................................................... 20 
12.0.............................................................................................................. REFERENCES
............................................................................................................................................21 
13.0............................................................................................................... APPENDICES
................................................................................................ Error! Bookmark not defined. 


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LIST OF ABBREVIATIONS (EXAMPLES) 
AE 
Adverse Event 
ALT 
Alanine Aminotransferase 
ALC 
Absolute Lymphocyte Count 
ASCO 
American Society of Clinical Oncology 
AST 
Aspartate Aminotransferase 
BUN 
Blood Urea Nitrogen 
CBC 
Complete Blood Count 
CMP 
Comprehensive Metabolic Panel 
CR 
Complete Response 
CT 
Computed Tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
DLT 
Dose Limiting Toxicity 
DOT 
Disease Oriented Team 
DSMB 
Data and Safety Monitoring Board 
ECOG 
Eastern Cooperative Oncology Group 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
H&P 
History & Physical Exam 
HRPP 
Human Research Protections Program 
IDE 
Investigational Device Exemption 
IHC 
Immunohistochemistry 
IND 
Investigational New Drug 
IV (or iv) 
Intravenously 
MRI 
Magnetic Resonance Imaging 
MTD 
Maximum Tolerated Dose 
NCI 
National Cancer Institute 
ORR 
Overall Response Rate 
OS 
Overall Survival 
PBMCs 
Peripheral Blood Mononuclear Cells 
pCR 
Pathologic Complete Response 
PD 
Progressive Disease 
PET 
Positron Emission Tomography 
PFS 
Progression Free Survival 
p.o. 
peros/by mouth/orally 
PR 
Partial Response 
RCB 
Residual Cancer Burden 
RECIST 
Response Evaluation Criteria in Solid Tumors 
SAE 
Serious Adverse Event 
SCCC 
Simmons Comprehensive Cancer Center 
SD 
Stable Disease 


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SGOT 
Serum Glutamic Oxaloacetic Transaminase 
SPGT 
Serum Glutamic Pyruvic Transaminase 
WBC 
White Blood Cells 
 
 
STUDY SCHEMA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patients with suspected prostate cancer who have at least one PI-RADS 5 
lesion, or at least one PI-RADS 4 lesion and PSA ≥10 ng/mL on standard of 
care multiparametric MRI (mp-MRI) of the prostate 
Patients scheduled for targeted prostate biopsy or radical 
prostatectomy 
Dynamic and static 68Ga PSMA-11 PET/CT – research study
Comparison of 68Ga PSMA-11 PET/CT with prostate mp-MRI and 
pathology for detection of primary prostatic lesion and comparison 
of 68Ga PSMA-11 PET/CT with standard of care imaging for 
detection of metastatic disease 


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STUDY SUMMARY 
 
Title 
The Role of 68Ga PSMA-11 in Enhancing Diagnosis of Primary and 
Metastatic Prostate Cancer 
Short Title 
68Ga PSMA-11 PET/CT in Prostate Cancer 
Protocol Number 
STU-2019-1198 
Phase 
Phase 2 
Methodology 
Unblinded single arm imaging study 
Study Duration 
2 years 
Study Center(s) 
Single-center  
Objectives 
To assess the ability of 68Ga PSMA-11 PET/CT to increase diagnostic 
accuracy in localizing primary and metastatic lesions in patients with 
suspected prostate cancer and elevated PI-RADS scores and PSA. 
Number of Subjects 
20 
Diagnosis and Main 
Inclusion Criteria 
Patients with suspected prostate cancer who have at least one PI-RADS 
5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 ng/mL on 
standard conventional imaging multiparametric MRI (mp-MRI) of the 
prostate and scheduled for biopsy or radical prostatectomy. 
Study Product(s), Dose, 
Route, Regimen 
68Ga Prostate Specific Membrane Antigen-11, single intravenous 
injection, 1.8 – 2.2 MBq/kg body weight 
Duration of administration 
Single intravenous administration 
Reference therapy 
Imaging study only 
Statistical Methodology 
Descriptive statistics only 
 
 
 


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1.0 
BACKGROUND AND RATIONALE 
1.1 
Disease Background 
In developed countries, prostate cancer is the most common malignancy in men and the 
third leading cause of death in men [1, 2]. Despite being a common cancer, it has proven 
challenging to diagnose accurately both primary and metastatic lesions. There are 
numerous reasons for this challenge including the insensitivity of serum prostate specific 
antigen(PSA) in distinguishing benign from malignant disease, sampling errors in 
unguided biopsies of the prostate, and the multifocal nature of prostate cancer lesions 
within the prostate [3].  
In the evaluation of primary prostate cancer, the use of multi parametric MRI (mp-MRI) 
has increased the detection of primary prostate cancer, but there is still a significant 
number of undetected lesions using this technique. A recent large study [3], which 
correlated pre-prostatectomy mp-MRI imaging with post prostatectomy whole mount 
pathology (WMP) of the resected gland, reported that less than half of all individual 
prostate cancer lesions were identified. These tumors were most commonly small lesions 
(<1 cm), multifocal lesions, lesions associated with Gleason score < 3+3, and with 
Prostate Imaging –Reporting and Data System (PI-RADS) v2.1 score < 4. However, 
some of these undetected lesions have elevated PSA and Gleason scores ≥ 7, making 
more aggressive biologic behavior likely [3]. 
In addition, accurate localization of metastatic lesions outside the prostate with standard 
of care imaging, such as magnetic resonance imaging (MRI) and computed tomography 
(CT) of the pelvis, lack sensitivity as they are dependent upon size criteria and may not 
detect disease in smaller nodes [4]. Planar bone scintigraphy, standard of care in high-
grade tumors, may also under identify small lesions and may lack specificity due to 
uptake in additional common benign disease [5]. For these reasons, it is desirable to 
pursue additional imaging with greater sensitivity and specificity for detecting primary 
tumors as well as staging for metastatic disease [6]. 
1.2 
Study Agent(s)/Therapy(ies) Background and Associated Known Toxicities 
In the last several years, molecular imaging using a variety of radiopharmaceuticals has 
been used to enhance the detection of both primary and metastatic lesions, with varying 
degrees of sensitivity. Some of the most promising of these are radio-ligands that target 
prostate specific membrane antigen (PSMA), a glycoprotein membrane antigen that is 
over expressed in the majority of prostate cancers. One of these ligands is 68Ga labelled 
(Glu-NH-CO-NH-Lys(AHX)-HBED-CC;HBED=N,N’-bis[2-hydroxy-5-(carboxyethyl)benzy] 
ethylenediamine-N,N’-diacetic acid) (68Ga PSMA-11) which can be imaged using positron 
emission tomography with computed tomography (PET/CT) [1]. 68Ga PSMA-11 PET/CT 
has been used extensively to evaluate patients with prostate cancer outside of the United 
States. It has been found useful in the diagnosis of primary tumors [5, 7] and metastatic 
lesions [1, 8-10]. It has been useful in the setting of biochemical relapse, when PSA 
begin to rise, but is still relatively low, following definitive therapy [11, 12]. According to 
clinicaltrials.gov, there are currently (June 2019) 68 ongoing trials using 68Ga PSMA-11 in 
the United States and other countries.  
The toxicity of the precursor PSMA-11 has been reported to be below the no-observed-
adverse-effect-level (NOEL). 86 μg PSMA-11 per kg body weight administered i.v. in one 
species (female and male rat) in the single-dose acute toxicity was below the NOEL. 
Based on the referenced study, a safety factor of 1000 can be assumed for a maximum 
human dose of PSMA-11 of 6.3 nmol or 6 μg per injection for a standardized patient of 70 
kg body weight at a maximal concentration of 0.6 μg/mL (AURIGON 770.321.4369) [15]. 


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1.3 
Other Agents 
None.  
1.4 
Rationale 
A recent case report has documented that 68Ga PSMA-11 PET/CT may identify a 
prostate primary lesion even when mp-MRI does not [13]. In addition, mp- MRI may 
detect only a single lesion with PI-RADS v 2.1 ≥4 but prostate cancer is often multifocal 
[3] and with the addition of 68Ga PSMA-11 PET/CT, those additional prostatic lesions 
might be identified. Several studies have demonstrated that early dynamic PET/CT 
imaging immediately after injection of 68Ga PMSA-11 can enhance primary prostate 
cancer detection as tumor uptake begins rapidly after injection and before the urinary 
bladder begins to fill with excreted tracer [7, 14]. 
In addition to identifying primary prostatic lesions, it is possible that 68Ga PMSA-11 
PET/CT may be able to detect more metastatic disease than that detected on current 
standard of care staging imaging for patients with elevated PI-RADS scores and PSA 
values. 68Ga PMSA-11 PET/CT is reported to be able to detect small suspicious nodes 
and extra prostatic lesions due to its greater sensitivity and specificity compared to a 
variety of other imaging modalities [4, 8, 12]. 
The purpose of the proposed research is to evaluate the added value of 68Ga PSMA-11 
PET/CT in relation to detect additional primary prostate cancer lesions compared to mp-
MRI in a group of patients with elevated PI-RADS scores and PSA. We propose that the 
addition of early dynamic 68Ga PMSA-11 PET/CT imaging to the more usual delayed 
imaging will enhance detection of primary lesions and additional lesions not detected on 
the mp-MRI. In addition, the dynamic imaging will allow us to evaluate the kinetics of 
uptake in the prostate gland. It is possible that even in the absence of focal uptake, 
hyperemia of the gland could indicate the presence of an occult primary. 
A second purpose of this research is to examine the value of 68Ga PSMA-11 PET/CT in 
this same group of patients in detecting metastatic disease at initial staging in 
comparison with current standard of care imaging such as CT and MRI.  
1.5 
Correlative Studies 
2.0 
 N/ASTUDY OBJECTIVES 
2.1 
Primary Objectives 
 
2.1.1 
To assess whether 68Ga PSMA-11 PET/CT can detect additional primary 
prostate cancer lesions through use of early dynamic PET/CT imaging in 
comparison to mp-MRI in patients with PI-RADS v2.1 score 5 (with any PSA), or 
score 4 and PSA ≥ 10 ng/mL. 
2.2 
Secondary Objectives 
 
2.2.1 
To assess whether 68Ga PSMA-11 PET/CT can detect additional sites of 
metastatic disease at staging in comparison to standard of care imaging in 
patients with PI-RADS v2.1 score 5 (with any PSA), or score 4 and PSA ≥ 10 
ng/mL 
 
2.3 
Exploratory Objectives 
None 


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2.4 
Endpoints 
The primary endpoint is to determine per lesion sensitivity of 68Ga PSMA-11 for the 
detection of prostatic lesions in patients with elevated PSA and abnormal mp-MRI of the 
prostate (as defined as at least one lesion with PI-RADS v2.1 score 5 with any PSA or 
score 4 and PSA ≥10 ng/mL). A second endpoint will be to determine per person 
sensitivity of 68Ga PSMA-11 for the detection of metastatic disease, compared to 
standard of care imaging. 
3.0 
Subject ELIGIBILITY 
Eligibility waivers are not permitted. Subjects must meet all of the inclusion and exclusion criteria 
to be registered to the study. Study treatment may not begin until a subject is registered. 
3.1 
Inclusion Criteria 
 
3.1.1 
Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, 
elevated and/or rising PSA) as determined by referring physician 
 
3.1.2 
Patients must have had a diagnostic, standard of care mp-MRI of the prostate 
with at least one lesion with a PI-RADS v2.1 score ≥ 4 
 
3.1.3 
In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL. In men with at 
least one PI-RADS v2.1 score 5 lesion, there is no restriction on PSA level.     
 
3.1.4 
Patients must be scheduled for biopsy or radical prostatectomy 
 
3.1.5 
Patients must be older than 18 years of age 
 
 
 
 
3.1.6 
Patients should not have had any type of curative or palliative therapy for 
prostate cancer before enrolling in the study 
 
3.1.7 
Patients must be medically stable as judged by the patient’s physician 
 
3.1.8 
Patients must be able to lie still for a total of 60 minutes for the PET/CT scans 
 
3.1.9 
Ability to understand and the willingness to sign a written informed consent 
3.2 
Exclusion Criteria 
 
3.2.1 
Patients who have had a prior prostatectomy or radiotherapy for prostate cancer 
cannot participate in the study  
 
3.2.2 
Patients who have had a prior biopsy for prostate cancer cannot participate in the 
study 
 
3.2.3 
Patients who have been treated for cancers other than skin cancers 
 
3.2.4 
Subjects may not be receiving any other investigational agents for the treatment 
of the cancer under study 
 
3.2.5 
Patients may not weigh more than the maximum weight limit for the PET/CT 
scanner table (>200kg or 440 lbs) 
 


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3.2.6 
History of allergic reactions attributed to compounds of similar chemical or biologic 
composition to 68Ga PSMA-11 or other agents used in the study such as 
gadolinium-based intravenous contrast agent used during the mp-MRI 
 
3.2.7 
Prior TURP/BPH procedures, including steam/laser therapies.  
 
 
4.0 
TREATMENT PLAN 
4.1 
Injection of 68Ga PSMA-11 
 
 
This is a nontherapeutic imaging only study. There will be a single IV injection of 1.8 – 2.2 
MBq (0.049-0.059 mCi) per kilogram of body weight of 68Ga PSMA-11 [15]. Injections will 
be performed in the PET/CT Imaging Services located on the 2nd floor of the Clements 
Building at UT Southwestern Medical Center.  
4.2 
Scan Acquisition 
Patients will be scanned on a 128 slice PET/CT scanner. The patient will be positioned 
supine, with arms elevated above the head as tolerated by the patient. Data acquisition 
will occur as 2 discrete components: 1) a dynamic part (dPET/CT studies) and the static 
part (whole-body PET/CT). With the patient on the scanning table, the patient will be 
injected with 68Ga PSMA-11 and dPET/CT scanning will be performed over the pelvic 
area for 30 minutes [11, 12, 16]. The dPET/CT will be obtained in list mode with dynamic 
frames acquired at 10 x 30 seconds, 5 x 60 seconds, 5 x 120 seconds and 2 x 300 
seconds. At 60 minutes post injection, a standard whole body PET scan with images from 
vertex of the skull to the feet will be acquired at 2-3 minutes per bed step, adjusted for 
body weight, along with CT images over the same range. The manufacturer’s CT dose 
exposure limit software will be utilized. CT data will be used for attenuation correction and 
for anatomic localization of uptake sites [15]. The CT data will be reconstructed with soft 
tissue (B40f) and bone (B80) kernels.  
 
4.3 
Imaging Analysis 
For the dynamic scan, all frames will be summed to produce a single image over the 
pelvis. This image will be visually evaluated for focal uptake in and around the prostate 
gland. In addition, the dynamic image frames will also be used to construct time activity 
curves comparing post injection time vs standard uptake value (SUV) of 68Ga PSMA-11 
uptake. These curves will be constructed with volumes of interest in the prostate as a 
whole, in any visible focal prostate lesions and over the common left iliac artery to 
provide an arterial input curve. If metastatic lesions are detected on this scan, separate 
time activity curves will be calculated as well. 
 
Whole body images will be visually and quantitatively evaluated independently by two 
experienced PET/CT readers. The readers will first assess whether the primary tumor is 
visually distinguishable from the surrounding prostate tissue. A prostate tumor will be 
judged positive if the focal tracer uptake is higher than that of the surrounding prostate 
tissue. For calculations of SUV, a VOI will be drawn around areas of focal uptake within 
the prostate using iso-contour (SUVmax). The same size VOI will be drawn in the region 
of the uninvolved prostate. If no focal uptake is seen in the prostate, a VOI will be drawn 
around the prostate. 
 
Comparisons will be made between the interpretations provided by the two PET/CT 
readers and the degree of agreement will be calculated. Mean and maximum SUVs will 


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be obtained on all areas of interest. Anatomic measurements of suspicious lymph nodes 
will be made in the short axis.  
 
To evaluate focal uptake in lymph nodes and distant metastatic disease, VOIs will be 
drawn around each lesion. SUV maximum and mean will be recorded for all lesions. In 
addition, VOIs will be drawn around normal uptake in the prostate and a 2 cubic 
centimeter VOI will be drawn in the gluteal muscle, for use as normal background [7]. A 
lesion will be considered positive when the uptake exceeds normal background. 
 
Because of the small number of subjects, descriptive statistics will used, such as 
percentage of times a focus of uptake in the prostate can be seen on the PET/CT and 
whether this focus corresponds to any detectable abnormality on review of mp-MRI of the 
prostate. With regard to lesions outside the prostate, comparison will be made with the 
results from the 68Ga PSMA-11 scan and possible lesions seen on conventional imaging, 
such as pelvic CT or MRI or bone scintigraphy.  
 
If possible, biopsy confirmation of sites of abnormal focal 68Ga PSMA-11 uptake will be 
obtained per standard of care. If patient undergoes surgery without biopsy, findings of 
imaging will be correlated with whole mount pathology (WMP) of the resected gland with 
final pathology on the surgical specimen. For surgical patients, customized molds will be 
created based on MRI data to optimize co-registration of cross-sectional imaging and 
pathology data, as previously reported by our group [17]. If a patient undergoes radiation 
therapy or other ablation treatment without biopsy, post treatment conventional imaging 
will be performed and results will be compared for regression in size 
4.4 
Concomitant Medications/Treatments 
Patients should not be receiving any treatment for prostate cancer, including anti 
androgen therapy as this can affect 68Ga PSMA-11 uptake.  
4.5 
Other Modalities or Procedures 
The initial mp-MRI of the prostate is standard of care and not part of the research 
protocol. Per current guidelines [18], cross sectional imaging (CT or MRI) is also 
considered standard of care in men with unfavorable intermediate or high risk disease.  
4.6 
Duration of Follow Up 
2 years 
4.7 
Removal of Subjects from Protocol 
Subjects will be removed from therapy when any of the criteria listed in Section 5.5 apply. 
Notify the Principal Investigator, and document the reason for treatment discontinuation 
and the date of discontinuation. The subject should be followed-up per protocol.  
4.8 
Subject Replacement 
If a subject is removed from the study for any reason, he may be replaced. 
5.0 
STUDY PROCEDURES 
5.1 
Screening/Baseline Procedures 
Assessments performed exclusively to determine eligibility for this study will be done only 
after obtaining informed consent. Assessments performed for clinical indications (not 
exclusively to determine study eligibility) may be used for baseline values even if the 
studies were done before informed consent was obtained. 
 


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All screening procedures must be performed within 3 months prior to registration unless 
otherwise stated. The screening procedures include: 
5.1.1 Informed Consent 
 
Informed consent will be obtained from each research participant by the 
investigator or the study coordinator. No participant will be allowed to participate 
without a signed, IRB consent form 
5.1.2 Medical history 
Review of complete medical and surgical history up to 60 days available in the 
electronic medical record system at UT Southwestern Medical Center 
5.1.3 Demographics 
Age, gender, race, ethnicity 
5.1.4 Review subject eligibility criteria 
5.1.5 Review previous and concomitant medications 
5.1.6 Physical exam including vital signs, height and weight 
Vital signs (temperature, pulse, respirations, blood pressure), height, weight 
5.1.7 Adverse event assessment 
Baseline adverse events will be assessed. See section 7 for Adverse Event 
monitoring and reporting. 
5.1.8 Blood draw for correlative studies 
N/A 
5.1.9 
Serum chemistries 
None is needed for 68Ga PSMA-11 PET/CT. 
5.2 
Procedures During Treatment 
There is no planned treatment. The subjects will come to PET/CT imaging suite and an 
intravenous catheter will be placed. The subject will have height and weight measured in 
order to calculate dose of 68Ga PSMA-11 to be injected. 
5.3 
Follow-up Procedures 
Follow-up of patient’s clinical condition, pathology, laboratory values and imaging studies 
related to the study disease will occur for 2 years to correlate with the imaging results. 
Adverse events will be evaluated up to 24 hours. Due to the drug’s short half-life of 68 
min and the toxicological profile, no long-term toxicities are anticipated.  
 
 
 
 
 
 
 
 
 


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5.4 
Time and Events Table  
 
 
Event 
Visit 1: screening 
Visit 2:
68GA PSMA-11 
PET/CT 
Follow-up 
Informed Consent 
X 
 
 
Demographics 
X 
 
 
Clinical history 
X 
 
 
Height/weight 
X 
X 
 
Physical exam 
X 
 
 
Survival/patient 
status 
 
 
X 
Review pathology 
records 
 
X 
68 Ga PSMA-11 
PET/CT 
 
X 
 
Other radiologic 
studies (CT or MRI) 
X 
X 
Adverse event 
evaluation* 
 
X 
*Adverse event evaluation up to 24 hours post injection.  
5.5 
Removal of Subjects from Study 
Subjects may withdraw from the study at any time at their own request, or they may be 
withdrawn at the discretion of the investigator for safety, behavioral or administrative 
reasons. The reason(s) for discontinuation will be documented and may include: 
5.5.1 
Subject voluntarily withdraws from treatment (follow-up permitted); 
5.5.2 
Subject withdraws consent (termination of treatment and follow-up); 
5.5.3 
Subject is unable to comply with protocol requirements; 
5.5.4 
Subject experiences toxicity that makes continuation in the protocol unsafe; 
5.5.6 
Treating physician determines that continuation on the study would not be in the 
subject’s best interest; 
5.5.7 
Subject becomes pregnant (pregnancy to be reported along same timelines as a 
serious adverse event); 
5.5.9 
Lost to follow-up. If a research subject cannot be located to document disease 
state after a period of 2 years, the subject may be considered “lost to follow-up”. 
All attempts to contact the subject during the two years must be documented and 
approved by the Data Monitoring Committee. 
6.0 
Measurement of Effect 
This is a non-therapeutic, exploratory protocol. The protocol focuses on exploring the ability of 
68Ga PSMA-11 to demonstrate primary and metastatic disease in patients with suspected 
prostate cancer. 


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6.1 
Safety/tolerability 
 
As with all PET/CT imaging agents, 68Ga PSMA-11 is a radiopharmaceutical that decays 
with positron emission, a form of radiation. This poses a radiation risk but this risk is 
extremely small at the dose administered in this study. The organ and total body doses 
associated with 68Ga PSMA-11 are comparable to or lower than those associated with 
other widely used clinical nuclear medicine procedures.  
The radiation absorbed effective dose from the intravenously injected 68Ga PMSA-11 is 
estimated to be 237 mRem (2.37mSv) [19]. 
Risks of PET/CT studies include those due to IV line placement. These risks include 
bleeding or possible hematoma at the site of the injection. A physician will be available to 
document the adequacy of the venous line and to provide assistance in case of 
inadvertent tracer extravasations or hematoma formation.  
All adverse events occurring within a 24 hour period post 68Ga PSMA-11 infusion will be 
recorded. The adverse events to be specifically monitored during the infusion include 
localized discomfort at the IV injection site, pain, respiratory difficulties, flushing, 
dizziness, pruritus/rash, and any other symptoms that could be secondary to an 
anaphylactic reaction. The subject will be instructed to report any subjective symptoms or 
sensory changes noted. 
7.0 
ADVERSE EVENTS 
7.1 
Experimental Therapy 
There is no experimental therapy. This is an imaging only study. 
7.1 
Adverse Event Monitoring 
Adverse event data collection and reporting, which are required as part of every clinical 
trial, are done to ensure the safety of subjects enrolled in the studies as well as those 
who will enroll in future studies. Adverse events are reported in a routine manner at 
scheduled times during a trial. Additionally, certain adverse events must be reported in an 
expedited manner to allow for optimal monitoring of subject safety and care.  
 
All subjects experiencing an adverse event, regardless of its relationship to study 
therapy, will be monitored until:  
 the adverse event resolves or the symptoms or signs that constitute the adverse 
event return to baseline or is stable in the opinion of the investigator;  
 there is a satisfactory explanation other than the study therapy for the changes 
observed; or 
 death. 
 
7.1.1 
Definitions  
An adverse event is defined as any untoward or unfavorable medical occurrence in a 
human research study participant, including any abnormal sign (for example, abnormal 
physical exam, imaging finding or clinically significant laboratory finding), symptom, 
clinical event, or disease, temporarily associated with the subject’s participation in the 
research, whether or not it is considered related to the subject’s participation in the 
research. 
Adverse events encompass clinical, physical and psychological harms. Adverse events 
occur most commonly in the context of biomedical research, although on occasion, they 


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can occur in the context of social and behavioral research. Adverse events may be 
expected or unexpected. 
Acute Adverse Events  
Adverse events occurring in the time period from the signing of the informed consent, 
through 24 hours post treatment will be considered acute adverse events.   
Severity  
Adverse events will be graded by a numerical score according to the defined NCI 
Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Adverse 
events not specifically defined in the NCI CTCAE will be scored on the Adverse Event log 
according to the general guidelines provided by the NCI CTCAE and as outlined below.   
 
Grade 1: Mild  
 
Grade 2: Moderate 
 
Grade 3: Severe or medically significant but not immediately life threatening 
 
Grade 4: Life threatening consequences 
 
Grade 5: Death related to the adverse event 
 
Serious Adverse Events  
ICH Guideline E2A and the UTSW IRB define serious adverse events as those events, 
occurring at any dose, which meets any of the following criteria:  
 
Results in death   
 
Immediately life-threatening  
 
Results in inpatient hospitalization1,2 or prolongation of existing hospitalization  
 
Results in persistent or significant disability/incapacity  
 
Results in a congenital anomaly/birth defect  
 
Based upon appropriate medical judgment, may jeopardize the subject’s health 
and may require medical or surgical intervention to prevent one of the other 
outcomes listed in this definition. 
Note: A “Serious adverse event” is by definition an event that meets any of the above 
criteria. Serious adverse events may or may not be related to the research project. A 
serious adverse event determination does not require the event to be related to the 
research. That is, both events completely unrelated to the condition under study and 
events that are expected in the context of the condition under study may be serious 
adverse events, independent of relatedness to the study itself. As examples, a car 
accident requiring >24 hour inpatient admission to the hospital would be a serious 
adverse event for any research participant; likewise, in a study investigating end-stage 
cancer care, any hospitalization or death which occurs during the protocol-specified 
period of monitoring for adverse and serious adverse events would be a serious adverse 
event, even if the event observed is a primary clinical endpoint of the study. 
1Pre-planned hospitalizations or elective surgeries are not considered SAEs. Note: If 
events occur during a pre-planned hospitalization or surgery, that prolong the existing 
hospitalization, those events should be evaluated and/or reported as SAEs.   
2 NCI defines hospitalization for expedited AE reporting purposes as an inpatient hospital 
stay equal to or greater than 24 hours. Hospitalization is used as an indicator of the 
seriousness of the adverse event and should only be used for situations where the AE 


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13 
truly fits this definition and NOT for hospitalizations associated with less serious events. 
For example: a hospital visit where a patient is admitted for observation or minor 
treatment (e.g. hydration) and released in less than 24 hours. Furthermore, 
hospitalization for pharmacokinetic sampling is not an AE and therefore is not to be 
reported either as a routine AE or in an expedited report. 
7.1.2 
Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs): 
The phrase “unanticipated problems involving risks to subjects or others” is found, but not 
defined in the HHS regulations at 45 CFR 46, and the FDA regulations at 21 CFR 
56.108(b)(1) and 21 CFR 312.66. For device studies, part 812 uses the term 
unanticipated adverse device effect, which is defined in 21 CFR 812.3(s). Guidance from 
the regulatory agencies considers unanticipated problems to include any incident, 
experience, or outcome that meets ALL three (3) of the following criteria: 
• 
Unexpected in terms of nature, severity or frequency given (a) the research procedures 
that are described in the protocol-related documents, such as the IRB-approved research 
protocol and informed consent document; and (b) the characteristics of the subject 
population being studied;  
 
 
 
 
AND 
• 
Related or possibly related to participation in the research (possibly related means there 
is a reasonable possibility that the incident, experience, or outcome may have been 
caused by the procedures involved in the research); 
 
AND  
• 
Suggests that the research places subjects or others at greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
recognized. Note: According to OHRP, if the adverse event is serious, it would always 
suggest a greater risk of harm. 
 
Follow-up  
All adverse events will be followed up according to good medical practices.  
  
7.2 
Steps to Determine If a Serious Adverse Event Requires Expedited Reporting to the 
SCCC DSMC and/or HRPP 
Step 1: Identify the type of adverse event using the NCI Common Terminology Criteria 
for Adverse Events (CTCAE v5).  
 
Step 2: Grade the adverse event using the NCI CTCAE v5. 
 
Step 3: Determine whether the adverse event is related to the protocol therapy.  
Attribution categories are as follows: 
- 
Definite – The AE is clearly related to the study treatment. 
- 
Probable – The AE is likely related to the study treatment. 
- 
Possible – The AE may be related to the study treatment. 
- 
Unlikely – The AE may NOT be related to the study treatment. 
- 
Unrelated – The AE is clearly NOT related to the study treatment. 
Note: This includes all events that occur within 24 hours1 of the last dose of protocol 
treatment. Any event that occurs more than 24 hours after the last dose of treatment and 
is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as 
indicated in the sections below. 
 
1 Revised to 24 hours due to the drugs short half-life of 68 min. 


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14 
 
Step 4: Determine the prior experience of the adverse event. Expected events are those 
that have been previously identified as resulting from administration of the treatment. An 
adverse event is considered unexpected, for expedited reporting purposes only, when 
either the type of event or the severity of the event is not listed in: 
 
the current known adverse events listed in the Agent Information Section of this 
protocol (if applicable); 
 
the drug package insert (if applicable); 
 
the current Investigator’s Brochure (if applicable) 
 
the Study Agent(s)/Therapy(ies) Background and Associated Known Toxicities 
section of this protocol 
 
7.2.1 
Reporting SAEs and UPIRSOs to the Simmons Comprehensive Cancer Center 
(SCCC) Data Safety Monitoring Committee (DSMC) 
 
All SAE/UPIRSOs at all sites, which occur in research subjects on protocols for which the 
SCCC is the DSMC of record require reporting to the DSMC regardless of whether IRB 
reporting is required. All SAEs/UPIRSOs occurring during the protocol-specified 
monitoring period should be submitted to the SCCC DSMC within 5 business days of the 
PI or delegated study team members awareness of the event(s). In addition, for 
participating centers other than UTSW, local IRB guidance should be followed for local 
reporting of serious adverse events. 
 
The UTSW study team is responsible for submitting SAEs/UPIRSOs to the SCCC DSMC 
Coordinator.  Hardcopies or electronic versions of the eIRB Reportable Event report; FDA 
Form #3500A forms, or other sponsor forms, if applicable; and/or any other supporting 
documentation available should be submitted to the DSMC Coordinator.  The DSMC 
Coordinator forwards the information onto the DSMC Chairman who determines if 
immediate action is required.  Follow-up eIRB reports, and all subsequent SAE/UPIRSO 
documentation that is available are also submitted to the DSMC Chair who determines if 
further action is required. (See Appendix III of the SCCC DSMC Plan for a template Serious 
Adverse Event Form which may be utilized when a sponsor form is unavailable and SAE 
submission to the eIRB is not required). 
  
 
If the event occurs on a multi-institutional clinical trial coordinated by the UTSW Simmons 
Comprehensive Cancer Center, the DOT Manager or lead coordinator ensures that all 
participating sites are notified of the event and resulting action, according to FDA 
guidance for expedited reporting. DSMC Chairperson reviews all SAEs/UPIRSOs upon 
receipt from the DSMC Coordinator.  The DSMC Chairperson determines whether action 
is required and either takes action immediately, convenes a special DSMC session 
(physical or electronic), or defers the action until a regularly scheduled DSMC meeting.  
 
The following instructions section may be modified as needed to ensure clear guidance 
for institutions participating in the trial who will not report directly to the UTSW Institutional 
Review Board. If needed, this reporting may be facilitated by the UTSW study team for 
example.  
Telephone reports to: 
Neil M. Rofsky MD, 214-648-7702 
Neil.rofsky@utsouthwestern.edu   
 
Written reports to: 
Neil Rofsky MD 
Email: Neil.rofsky@utsouthwestern.edu  
 


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Fax: 214-648-7782 
 
UTSW SCCC Data Safety Monitoring Committee Coordinator 
Email: SCCDSMC@utsouthwestern.edu 
Fax: 214-648-5949 or deliver to BLB.306 
 
UTSW Institutional Review Board (IRB) 
Submit a Reportable Event via eIRB with a copy of the final sponsor report as attached 
supporting documentation 
 
Reporting Unanticipated Problems Involving Risks to Subjects or Others 
(UPIRSOs) to the UTSW HRPP/IRB 
 
UTSW reportable event guidance applies to all research conducted by or on behalf of UT 
Southwestern, its affiliates, and investigators, sites, or institutions relying on the UT 
Southwestern IRB. Additional reporting requirements apply for research relying on a non-
UT Southwestern IRB. 
 
According to UTSW HRPP/IRB policy, UPIRSOs are incidents, experiences, outcomes, 
etc. that meet ALL three (3) of the following criteria: 
1. Unexpected in nature, frequency, or severity (i.e., generally not expected in a 
subject’s underlying condition or not expected as a risk of the study; therefore, not 
included in the investigator’s brochure, protocol, or informed consent document),AND 
2. Probably or definitely related to participation in the research, AND 
3. Suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized.  Note: According to OHRP, if the adverse event is serious, it 
would always suggest a greater risk of harm. 
 
For purposes of this policy, UPIRSOs include unanticipated adverse device effects 
(UADEs) and death or serious injury related to a humanitarian use device (HUD).  
 
UPIRSOs must be promptly reported to the UTSW IRB within 5 working days of 
PI awareness. 
 
For research relying on a non-UT Southwestern IRB (external, central, or single IRB): 
 
Investigators relying on an external IRB who are conducting research on behalf of UT 
Southwestern or its affiliates are responsible for submitting LOCAL UPIRSOs to the UT 
Southwestern IRB within 5 working days of PI awareness. Investigators must report to 
their relying IRB according to the relying IRB’s policy. In addition, the external IRB’s 
responses or determinations on these local events must be submitted to the UT 
Southwestern IRB within 10 working days of receipt. 
 
Events NOT meeting UPIRSO criteria: 
 
Events that do NOT meet UPIRSO criteria should be tracked, evaluated, summarized, 
and submitted to the UTSW HRPP/IRB at continuing review. 
 
For more information on UTSW HRPP/IRB reportable event policy, see 
https://www.utsouthwestern.edu/research/research-administration/irb/assets/policies-
combined.pdf. 


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7.3 
Unblinding Procedures 
The proposed study is not blinded. 
 
8.0 
DRUG/TREATMENT INFORMATION 
8.1 
68Ga labelled (68Ga labelled (Glu-NH-CO-NH-Lys(AHX)-HBED-CC; HBED=N,N’-bis[2-
hydroxy-5-(carboxyethyl)benzy]ethylenediamine-N,N’-diacetic acid)) 
 
 
Other names for the drug(s): 68Ga PSMA-11 
 
 
Classification - type of agent: radiopharmaceutical for imaging purposes 
 
 
Mode of action: Binds to the prostate specific antigen, a cell surface protein which is 
over expressed in the majority of prostate cancers. 
 
 
Storage and stability: The drug solution is stored at room temperature in a gray butyl 
septum sealed, sterile, pyrogen-free glass vial and has an expiration time of 4 hours. 
 
 
Protocol dose: 1.8- 2.2. MBq/kg of body weight 
 
 
Preparation: Provided as unit dose by the UTSW cyclotron facility to inject into 
patients. 68Ga PSMA-11 is administered to subjects by intravenous injection. The 
drug solution is stored at room temperature in a gray butyl septum sealed, sterile, 
pyrogen-free glass vial and has an expiration time of 4 hours 
 
 
Route of administration for this study: intravenous 
 
 
Incompatibilities: none known 
 
 
Availability: Produced at the UTSW Cyclotron facility under an FDA IND 
 
 
Side effects: none known 
 
8.1.1 
Return and Retention of Study Drug 
Any unused 68Ga PSMA-11 will be stored at the UTSW Cyclotron Facility for up 
to 1 year in the event that additional testing for quality control is required. 
9.0 
CORRELATIVES/SPECIAL STUDIES 
 
Standard of care imaging tests will be performed by the treating physician as detailed above. 
 
Tissue obtained at the time of prostatectomy or biopsy will be reviewed for correlation with 
imaging tests. 
10.0 
STATISTICAL CONSIDERATIONS 


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10.1 
Study Design/Study Endpoints 
This is a prospective, unblended single arm, single institution phase II pilot study to 
explore use of 68Ga PSMA-11 PET/CT in aiding diagnosis of primary prostate cancer and 
prostate cancer metastases compared to current conventional imaging. 
10.2 
Sample Size and Accrual 
This pilot study will generate preliminary data regarding improved diagnosis with 68Ga 
PSMA-11 to support a larger future study of using hybrid PET/MRI in diagnosis of 
prostate cancer.  
It is anticipated that up to 20 patient will be enrolled. As this is a pilot study, nor formal 
sample size calculations are required.  
10.3 
Data Analyses 
Because of the small number of subjects, descriptive statistics will be used, such as 
percentage of times a focus of uptake in the prostate can be seen on the PET/CT and 
whether this focus corresponds to any detectable abnormality on review of mp-MRI of the 
prostate. To be specific, we will summarize percent of incidences when 1) PET/CT is 
concordant with mp-MRI, 2) uptake seen on PET/CT but normal on mp-MRI and 3) no 
uptake on PET/CT but abnormal seen on mp-MRI. This will be displayed in a two-by-two 
contingency table. 
 
Comparison will also be made to pathologic specimens from biopsy and/or prostatectomy 
(as reference standard) to correlate whether abnormal foci of tracer uptake correspond to 
sites of tumor. The per-lesion diagnostic performance of PET/CT (sensitivity and false 
positives) will be reported.  This will be displayed in a two-by-two contingency table. 
 
With regard to lesions outside the prostate, comparison will be made of the results from 
the 68Ga PSMA-11 scan and possible lesions seen on conventional imaging, such as 
pelvic CT or MRI or bone scintigraphy. To be specific, we will summarize percent of 
incidences when 1) PET/CT is concordant with pelvic CT/MR/BS, 2) uptake seen on 
PET/CT but normal on pelvic CT/MR/BS and 3) no uptake on PET/CT but lesion seen on 
pelvic CT/MR/BS. This will be displayed in a two-by-two contingency table. 
 
If possible, biopsy confirmation of sites of abnormal focal 68Ga PSMA-11 uptake outside 
the prostate gland will be obtained. If biopsy is not possible due to position or size of 
suspected lesion, post treatment conventional imaging will be performed and results will 
be compared for regression in size. The per-site diagnostic performance of PET/CT 
(sensitivity and false positives) will be reported. This will be displayed in a two-by-two 
contingency table. 
  
Agreement between two readers in continuous measurements (mean and max SUV) will 
be assess by intraclass correlation coefficients (ICC) and Bland-Altman plots per area of 
interest. Agreement between two readers in discrete measurements (visual 
distinguishability of primary tumor, additional primary lesion, sites of metastasis) will be 
assessed by Cohen’s kappa. 
11.0 
STUDY MANAGEMENT 
11.1 
Conflict of Interest 
 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, 
or financial gain greater than the minimum allowable by their institution, etc.) must have 
the conflict reviewed by the UTSW COI Committee and IRB according to UTSW Policy 


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on Conflicts of Interest.  All investigators will follow the University conflict of interest 
policy. 
 
11.2 
Institutional Review Board (IRB) Approval and Consent 
It is expected that the IRB will have the proper representation and function in accordance 
with federally mandated regulations. The IRB must approve the consent form and 
protocol. 
 
In obtaining and documenting informed consent, the investigator should comply with the 
applicable regulatory requirement(s), and should adhere to Good Clinical Practice (GCP) 
and to ethical principles that have their origin in the Declaration of Helsinki. 
 
 
Before recruitment and enrollment onto this study, the subject will be given a full 
explanation of the study and will be given the opportunity to review the consent form. 
Each consent form must include all the relevant elements currently required by the FDA 
Regulations and local or state regulations. Once this essential information has been 
provided to the subject and the investigator is assured that the subject understands the 
implications of participating in the study, the subject will be asked to give consent to 
participate in the study by signing an IRB-approved consent form. 
 
Prior to a patient’s participation in the trial, the written informed consent form should be 
signed and personally dated by the subject and by the person who conducted the 
informed consent discussion. 
11.3 
Required Documentation (for multi-site studies) 
 
This is a single site imaging study. 
 
11.4 
Registration/Randomization Procedures 
 
All subjects must be registered with the UTSW Radiology Clinical Research Office before 
enrollment to study. Prior to registration, eligibility criteria must be confirmed with the PI 
or Study Coordinator. To register a subject, call 214-645-1568 Monday through Friday, 
9:00AM-5:00PM.  
 
Subjects will be registered after PI has confirmed eligibility and study number will be 
generated in Velos.   
11.5 
Data Management and Monitoring/Auditing 
 
REDCap is the UTSW SCCC institutional choice for the electronic data capture of case 
report forms for SCCC Investigator Initiated Trials. REDCap will be used for electronic 
case report forms in accordance with Simmons Comprehensive Cancer Center 
requirements, as appropriate for the project 
 
Trial monitoring will be conducted no less than annually and refers to a regular interval 
review of trial related activity and documentation performed by the DOT and/or the CRO 
Multi-Center IIT Monitor. This review includes but is not limited to accuracy of case report 
forms, protocol compliance, timeless and accuracy of Velos entries and AE/SAE 
management and reporting. Documentation of trial monitoring will be maintained along 
with other protocol related documents and will be reviewed during internal audit.   
 
The UTSW Simmons Comprehensive Cancer Center (SCCC) Data Safety Monitoring 


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19 
Committee (DSMC) is responsible for monitoring data quality and patient safety for all 
UTSW SCCC clinical trials.  As part of that responsibility, the DSMC reviews all local 
serious adverse events and UPIRSOs in real time as they are reported and reviews 
adverse events on a quarterly basis.  The quality assurance activity for the Clinical 
Research Office provides for periodic auditing of clinical research documents to ensure 
data integrity and regulatory compliance.  A copy of the DSMC plan is available upon 
request. 
 
The SCCC DSMC meets quarterly and conducts annual comprehensive reviews of 
ongoing clinical trials, for which it serves as the DSMC of record. The QAC works as part 
of the DSMC to conduct regular audits based on the level of risk. Audit findings are 
reviewed at the next available DSMC meeting.  In this way, frequency of DSMC 
monitoring is dependent upon the level of risk.  Risk level is determined by the DSMC 
Chairman and a number of factors such as the phase of the study; the type of 
investigational agent, device or intervention being studied; and monitoring required to 
ensure the safety of study subjects based on the associated risks of the study. Protocol-
specific DSMC plans must be consistent with these principles.  
11.6 
Adherence to the Protocol 
Except for an emergency situation, in which proper care for the protection, safety, and 
well-being of the study subject requires alternative treatment, the study shall be 
conducted exactly as described in the approved protocol.  
11.6.1 Exceptions (also called single-subject exceptions or single-subject waivers): 
include any departure from IRB-approved research that is not due to an 
emergency and is: 
 intentional on part of the investigator; or 
 in the investigator’s control; or 
 not intended as a systemic change (e.g., single-subject exceptions to eligibility 
[inclusion/exclusion] criteria) 
 Reporting requirement: Exceptions are non-emergency deviations that require 
prospective IRB approval before being implemented. Call the IRB if your 
request is urgent. If IRB approval is not obtained beforehand, this constitutes 
a major deviation. 
11.6.2 Emergency Deviations: include any departure from IRB-approved research that 
is necessary to:  
 avoid immediate apparent harm, or 
 protect the life or physical well-being of subjects or others 
 Reporting requirement: Emergency deviations must be promptly reported 
to the IRB within 5 working days of occurrence. 
 
11.6.3 Major Deviations (also called violations): include any departure from IRB-
approved research that: 
 
Harmed or placed subject(s) or others at risk of harm (i.e., did or has the 
potential to negatively affect the safety, rights, or welfare of subjects or 
others), or 
 
Affect data quality (e.g., the completeness, accuracy, reliability, or validity of 
the data) or the science of the research (e.g., the primary outcome/endpoint of 
the study) 


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 Reporting requirement: Major deviations must be promptly reported to  
the IRB within 5 working days of PI awareness. 
 
11.6.4 Minor Deviations: include any departure from IRB-approved research that: 
 
Did not harm or place subject(s) or others at risk of harm (i.e., did not or did 
not have the potential to negatively affect the safety, rights, or welfare of 
subjects or others), or 
 
Did not affect data quality (e.g., the completeness, accuracy, reliability, or 
validity of the data) or the science of the research (e.g., the primary 
outcome/endpoint of the study) 
 Reporting requirement: Minor deviations should be tracked and 
summarized in the progress report at the next IRB continuing review.
 
11.7 
Amendments to the Protocol 
Should amendments to the protocol be required, the amendments will be originated and 
documented by the Principal Investigator.  A summary of changes document outlining 
proposed changes as well as rationale for changes, when appropriate, is highly 
recommended.  When an amendment to the protocol substantially alters the study design 
or the potential risk to the patient, a revised consent form might be required.  
 
The written amendment, and if required the amended consent form, must be sent to the 
IRB for approval prior to implementation.  
11.8 
Record Retention 
Study documentation includes all Case Report Forms, data correction forms or queries, 
source documents, Sponsor-Investigator correspondence, monitoring logs/letters, and 
regulatory documents (e.g., protocol and amendments, IRB correspondence and 
approval, signed patient consent forms). 
 
Source documents include all recordings of observations or notations of clinical activities 
and all reports and records necessary for the evaluation and reconstruction of the clinical 
research study. 
 
Government agency regulations and directives require that the study investigator retain 
all study documentation pertaining to the conduct of a clinical trial. In the case of a study 
with a drug seeking regulatory approval and marketing, these documents shall be 
retained for at least two years after the last approval of marketing application in an 
International Conference on Harmonization (ICH) region. In all other cases, study 
documents should be kept on file until three years after the completion and final study 
report of this investigational study. 
11.9 
Obligations of Investigators 
The Principal Investigator is responsible for the conduct of the clinical trial at the site in 
accordance with Title 21 of the Code of Federal Regulations and/or the Declaration of 
Helsinki. The Principal Investigator is responsible for personally overseeing the treatment 
of all study patients. The Principal Investigator must assure that all study site personnel, 
including sub-investigators and other study staff members, adhere to the study protocol 
and all FDA/GCP/NCI regulations and guidelines regarding clinical trials both during and 
after study completion. 
 
The Principal Investigator at each institution or site will be responsible for assuring that all 
the required data will be collected and entered onto the Case Report Forms. Periodically, 


STU-2019-1198– SCCC#06819 
________________________________________________________________________ 
Primary PSMA Protocol - 3.10.2021 
21 
monitoring visits may be conducted and the Principal Investigator will provide access to 
his/her original records to permit verification of proper entry of data. At the completion of 
the study, all case report forms will be reviewed by the Principal Investigator and will 
require his/her final signature to verify the accuracy of the data. 
12.0 
REFERENCES 
1. 
Perera, M., et al., Sensitivity, Specificity, and Predictors of Positive (68)Ga-Prostate-
specific Membrane Antigen Positron Emission Tomography in Advanced Prostate Cancer: A 
Systematic Review and Meta-analysis. Eur Urol, 2016. 70(6): p. 926-937. 
2. 
Torre, L.A., et al., Global Cancer Incidence and Mortality Rates and Trends--An Update. 
Cancer Epidemiol Biomarkers Prev, 2016. 25(1): p. 16-27. 
3. 
Johnson, D.C., et al., Detection of Individual Prostate Cancer Foci via Multiparametric 
Magnetic Resonance Imaging. Eur Urol, 2019. 75(5): p. 712-720. 
4. 
Hovels, A.M., et al., The diagnostic accuracy of CT and MRI in the staging of pelvic lymph 
nodes in patients with prostate cancer: a meta-analysis. Clin Radiol, 2008. 63(4): p. 387-95. 
5. 
Suh, C.H., et al., Yield of bone scintigraphy for the detection of metastatic disease in 
treatment-naive prostate cancer: a systematic review and meta-analysis. Clin Radiol, 2018. 73(2): 
p. 158-167. 
6. 
Yaxley, J.W., et al., Risk of metastatic disease on (68) Ga-PSMA PET/CT scan for primary 
staging of 1253 men at the diagnosis of prostate cancer. BJU Int, 2019. 
7. 
Uprimny, C., et al., (68)Ga-PSMA-11 PET/CT in primary staging of prostate cancer: PSA 
and Gleason score predict the intensity of tracer accumulation in the primary tumour. Eur J Nucl 
Med Mol Imaging, 2017. 44(6): p. 941-949. 
8. 
Chaloupka, M., et al., (68)Gallium-Prostate-Specific Membrane Antigen PET/Computed 
Tomography for Primary and Secondary Staging in Prostate Cancer. Urol Clin North Am, 2017. 
44(4): p. 557-563. 
9. 
Lengana, T., et al., (68)Ga-PSMA PET/CT Replacing Bone Scan in the Initial Staging of 
Skeletal Metastasis in Prostate Cancer: A Fait Accompli? Clin Genitourin Cancer, 2018. 16(5): p. 
392-401. 
10. Pyka, T., et al., Comparison of bone scintigraphy and 68Ga-PSMA PET for skeletal staging 
in prostate cancer. European Journal of Nuclear Medicine and Molecular Imaging, 2016. 43(12): p. 
2114-2121. 
11. Ceci, F., et al., (68)Ga-PSMA PET/CT for restaging recurrent prostate cancer: which 
factors are associated with PET/CT detection rate? Eur J Nucl Med Mol Imaging, 2015. 42(8): p. 
1284-94. 
12. Emmett, L., et al., A Prospective, Multi-site, International Comparison of F-18 fluoro-
methyl-choline, multi-parametric magnetic resonance and Ga-68 HBED-CC (PSMA-11) in men with 
High-Risk Features and Biochemical Failure after Radical Prostatectomy: Clinical Performance and 
Patient Outcomes. J Nucl Med, 2018. 
13. Muehlematter, U.J., et al., 68Ga-PSMA PET/MR-Positive, Histopathology-Proven Prostate 
Cancer in a Patient With Negative Multiparametric Prostate MRI. Clin Nucl Med, 2018. 43(8): p. 
e282-e284. 


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22 
14. Perveen, G., et al., Role of Early Dynamic Positron Emission Tomography/Computed 
Tomography with 68Ga-prostate-specific Membrane Antigen-HBED-CC in Patients with 
Adenocarcinoma Prostate: Initial Results. Indian J Nucl Med, 2018. 33(2): p. 112-117. 
15. Fendler, W.P., et al., (68)Ga-PSMA PET/CT: Joint EANM and SNMMI procedure guideline 
for prostate cancer imaging: version 1.0. Eur J Nucl Med Mol Imaging, 2017. 44(6): p. 1014-1024. 
16. Sachpekidis, C., et al., 68Ga-PSMA-11 Dynamic PET/CT Imaging in Primary Prostate 
Cancer. Clin Nucl Med, 2016. 41(11): p. e473-e479. 
17. Costa, D.N., et al., Improved Magnetic Resonance Imaging-Pathology Correlation With 
Imaging-Derived, 3D-Printed, Patient-Specific Whole-Mount Molds of the Prostate. Invest Radiol, 
2017. 52(9): p. 507-513. 
18. Sanda, M.G., et al., Clinically Localized Prostate Cancer: AUA/ASTRO/SUO Guideline. 
Part I: Risk Stratification, Shared Decision Making, and Care Options. Journal of Urology, 2018. 
199(3): p. 683-690. 
19. Pfob, C.H., et al., Biodistribution and radiation dosimetry of (68)Ga-PSMA HBED CC-a 
PSMA specific probe for PET imaging of prostate cancer. Eur J Nucl Med Mol Imaging, 2016. 
43(11): p. 1962-70. 
 
 

ICF_001.pdf: 
Title of Study: The Role of 68Ga PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer  
 
STU2019-1198, Rofsky, FormE-Consent-Main, Mod_2, 04-06-20 
 
 
Page 1 of 9 
                           
UTSW Research Consent and Authorization Documents (v January 2019) 
 
DO NOT DISCLOSE 
Consent to be part of a Research Study 
To be conducted at  
The University of Texas Southwestern Medical Center  
 
Key Information about this Study  
The purpose of this research is to determine if a new radioactive imaging drug for positron emission tomography/ 
computed tomography (PET/CT) improves diagnosis of prostate cancer compared to standard imaging such as MRI, 
CT or bone scans. This imaging drug has been used extensively for investigational purposes in the United States 
and other countries.  
Participants will have had a blood test for prostate specific antigen (PSA) which may be elevated and will have 
undergone an MRI of the pelvis which shows at least one site suspicious for cancer. Each participant in this research 
will undergo a single PET/ CT session with this imaging drug which will take approximately one hour. The results 
from the PET/CT will be compared to any other imaging and any pathology results that you may have from biopsy or 
surgery for prostate cancer. Results of the PET/CT will be discussed with your treating doctor.  
Risks of the PET/CT include exposure to low levels of radiation during the scan. There may be discomfort or 
bleeding at the site of the intravenous injection of the imaging drug. Bruising at the injection site is possible as well. 
You may not receive any personal benefits from being in this study. 
 
 
Information about this form 
You may be eligible to take part in a research study.  This form gives you important information about the study.   
 
Please take time to review this information carefully.  You should talk to the researchers about the study and ask 
them any questions you have.  You may also wish to talk to others (for example, your friends, family, or a doctor) 
about your participation in this study.  If you decide to take part in the study, you will be asked to sign this form.  
Before you sign this form, be sure you understand what the study is about, including the risks and possible benefits 
to you. 
 
Please tell the researchers or study staff if you are taking part in another research study. 
 
Voluntary Participation - You do not have to participate if you don't want to.  You may also leave the study at any 
time.  If you decide to stop taking part in this research study, it will not affect your relationship with the UT 
Southwestern staff or doctors.  Whether you participate or not will have no effect on your legal rights or the quality of 
your health care. 
 
If you are a medical student, fellow, faculty, or staff at the Medical Center, your status will not be affected in any way. 
 
General Information – “Who is conducting this research?” 
 
Principal Investigator 
The Principal Investigator (PI) is the researcher directing this study; the PI is responsible for protecting your rights, 
safety and welfare as a participant in the research.  The PI for this study is Neil M. Rofsky MD, Department of 
Radiology at The University of Texas Southwestern Medical Center. 
 
Funding  
 
The Department of Radiology at UT Southwestern Medical Center is funding this study.  This department is providing 
money so that the researchers can conduct the study. 
 
 
IRB Approved Date: 4/6/2020


Title of Study: The Role of 68Ga PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer  
 
STU2019-1198, Rofsky, FormE-Consent-Main, Mod_2, 04-06-20 
 
 
Page 2 of 9 
                           
UTSW Research Consent and Authorization Documents (v January 2019) 
 
DO NOT DISCLOSE 
Purpose – “Why is this study being done?” 
This study is being performed to assess whether imaging with 68Gallium Prostate Specific Membrane Antigen-11 (68Ga 
PSMA-11) PET/CT can identify the site of prostate cancer and any metastasis that other imaging techniques have not 
identified. PSMA is a protein which is increased in most prostate cancer so this imaging agent will show where prostate 
tumors may be located.  
  
You are asked to participate in this research study of 68Ga PSMA-11 PET/CT because the levels of prostate specific 
antigen (PSA) in your blood may be elevated and your MRI identified at least one site suspicious for cancer. 68Ga 
PSMA-11 PET/CT has been used in the US and other countries and preliminary results show that it can aid in locating 
prostate cancer. This study is being done to assess the ability of this imaging to identify primary tumors and possible 
metastasis that other imaging techniques have not identified.    
 
The researchers hope to learn if 68Ga PSMA-11 can help in the diagnosis of prostate cancer. 
 
Investigational Use of Drug or Device 
This study involves the use of an investigational radioactive drug called 68Ga PSMA-11. “Investigational” means that 
the drug has not yet been approved by the U.S. Food & Drug Administration (FDA) for diagnosis or monitoring of 
prostate cancer.   
 
This study will help find out what effects, good and/or bad, this drug has on people who use it. The safety of this drug 
in humans has been tested in prior research studies; however, some side effects may not yet be known.   
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web 
site will not include information that can identify you. At most, the Web site will include a summary of the results. You 
can search this Web site at any time.  
 
Information about Study Participants – “Who is participating in this research?” 
 
You are being asked to be a participant in this study because you have suspected prostate cancer. 
 
How many people are expected to take part in this study?  
This study will enroll approximately 20 study participants. 
 
Information about Study Procedures – “What will be done if you decide to be in the research?” 
 
While you are taking part in this study, you will be asked to attend approximately 2 visits with the researchers or 
study staff. 
It will be necessary for you to return to the hospital/clinic once for your 68Ga PSMA-11 PET/CT. 
 
Screening – After you sign this consent to participate, exams, tests, and/or procedures may be done as described 
below to find out if you can continue in the study; this is called screening. We may be able to use the results of 
exams, tests, and/or procedures you completed before enrolling in this study.  You will be told which results we will 
obtain and which procedures will not have to be repeated.  Many of the procedures are described below as 
“standard of care” and would be done even if you do not take part in this research study. You will be told which 
ones are for “research only”. 
 
Screening Procedures 
To help decide if you qualify to be in this study, the researchers will ask you questions about your health, including 
medications you take and any surgical procedures you have had. 
You may also have to fill out certain forms or have the following exams, tests or procedures: 
IRB Approved Date: 4/6/2020


Title of Study: The Role of 68Ga PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer  
 
STU2019-1198, Rofsky, FormE-Consent-Main, Mod_2, 04-06-20 
 
 
Page 3 of 9 
                           
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DO NOT DISCLOSE 
 
A physical exam and medical history 
 
Vital signs; respiratory rate, heart rate, blood pressure, temperature, weight. 
 
The results of the blood tests done as part of your standard care will be used. 
 
Demographic information (age, sex, race/ethnic origin) 
 
The results of imaging tests done as standard of care will be used including imaging of the abdomen and 
pelvis (CT Abdomen and Pelvis or MR Abdomen Pelvis). 
 
This visit will take approximately 60 minutes and may be done as part of a routine visit with your doctor. 
 
The results of the screening exams, tests, and/or procedures will be reviewed to determine whether you will be 
allowed to continue in the study. If you are not allowed to continue in the study, the researcher will discuss the 
reasons with you and will discuss other possible options 
 
Study Procedures - as a participant, you will undergo the following procedures: 
You will meet initially with your doctor who will perform the above screening procedures. This visit will last 
approximately 60 minutes or will add approximately 60 min to your routine care visit. If you qualify to be included in 
the study you will return at a later date to have an injection of 68Ga PSMA-11 followed by a PET/CT scan. 
When you come for your PET/CT scan: 
 
Upon arrival at the Clinical PET Facility located on the 2nd floor of the Clements Imaging Building at UT 
Southwestern, you will have an opportunity to have questions answered regarding the procedure. 
 
An intravenous catheter (IV) will be placed in a vein in your arm by the imaging technologist or nurse, for the 
admission of the radioactive drug (68Ga PSMA-11). There may be some discomfort from the IV catheter and 
the injection of 68Ga PSMA-11. 
 
You will be asked to lie still inside a large, doughnut-shaped instrument, called PET/CT scanner, for a 30 
minute scan. After the completion of this scan you will remain comfortably sitting in one of the facility’s rooms. 
 
At 60 minutes after the injection of the drug, you will be encouraged to empty your bladder and you will be 
asked to lie still on the PET/CT scanner for a second whole body scan that will take approximately 15 – 20 
minutes. 
 
You will be observed for the duration of your staying at the PET Center for any side effects after the injection.  
 
The IV catheter will be removed at the end of the PET/CT scan and a pressure bandage will be placed on the 
IV site. After this you will be free to leave. 
 
You will receive a follow-up call 24 hours after your injection to check up on you and make sure you are not 
having any reaction or side effects after the injection. 
 
After you have completed the PET/CT scans you will follow-up with your doctor as you would otherwise do. 
Any subsequent treatment or imaging your doctor does is part of your routine clinical care and not part of the 
study.  
 
Could your participation end early? There are several reasons why the researchers may need to end your 
participation in the study (early withdrawal).  Some reasons are: 
 
The researcher believes that it is not in your best interest to stay in the study. 
 
You become ineligible to participate. 
 
Your condition changes and you need treatment that is not allowed while you are taking part in the study. 
 
You do not follow instructions from the researchers. 
 
The study is stopped. 
 
It is possible that this study will identify information about you that was previously unknown, such as disease status 
or risk. Any clinically relevant results of the research will be communicated to you. Clinically relevant means that the 
information indicates that you may be at risk for a serious illness known at the time of testing to be treatable and it 
can be confirmed. In that case, we will attempt to notify you using the contact information you have provided.   
IRB Approved Date: 4/6/2020


Title of Study: The Role of 68Ga PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer  
 
STU2019-1198, Rofsky, FormE-Consent-Main, Mod_2, 04-06-20 
 
 
Page 4 of 9 
                           
UTSW Research Consent and Authorization Documents (v January 2019) 
 
DO NOT DISCLOSE 
 
If you do not want to be notified of any of these incidental findings, please initial below.   
 
_____ Please do not notify me of any incidental findings obtained from this research. 
 
Risks – “What are the risks of participation in the research?” 
 
Risks from the specific research procedures (drug(s), interventions, or procedures) 
Everyone taking part in the study will be watched carefully for any side effects. However, the study doctors don’t 
know all the side effects that may happen. Be sure to tell your study doctor immediately, about any side effect that 
you have while taking part in the study. 
The following section will describe the risks related to each your participation in this research study. You should talk 
to your study doctor about any side effects or other problems that you have while taking part in the study. 
 
PET/CT Scan 
The PET/CT Scan uses a radiotracer (68Ga PSMA-11) to evaluate your prostate tumor. The PET/CT scan looks and 
feels like a CT scan and is performed in a donut shaped machine. Each of the two same day scans  is quiet and 
lasts about 30 minutes. You may feel some discomfort and/or fatigue from lying still during imaging. 
 
IV Catheter Insertion 
There are some risks associated with the insertion of a small plastic tube (IV catheter) into the blood vessel which 
include pain, bruising, swelling, infection from the catheter and formation of blood clots around the catheter in the 
blood. Dizziness and fainting are also possible risks. 
 
68Ga PSMA-11 
68Ga PSMA-11 is a radioactive drug that carries a small amount of radiation that can be detected by the PET/CT 
Scan. Based on the findings obtained from preclinical evaluation and clinical testing in humans, no major side effects 
from the radioactive tracer are expected. Regulatory bodies (FDA) that oversee the use of drugs and radiotracers in 
the US and other countries have not approved the sale or use of 68Ga PSMA-11 for human use during PET/CT, 
although they have allowed the use in this study. You will be closely monitored during and after the scan for allergic 
reactions such as breathing difficulty, rash, flushing, and all other possible symptoms. 
 
Infusion risk 
May cause discomfort, irritation, mild bruising, bleeding, leakage of drug solution, and rarely infection, nausea, and 
lightheadedness.  
 
Risks of Radiation 
Being part of this study will expose you to radiation that you may not receive as part of your standard care. The 
radiation you receive for your everyday care outweighs risks the radiation poses because it allows your doctor to 
provide appropriate medical care. The extra radiation you receive from this study may not help you in this way. 
However, everyone is exposed daily to a background of radiation from the earth, outer space, the food we eat, and 
the air we breathe. Some people may be exposed to larger amounts of radiation (up to about 15 times more than this 
natural and background each year) because of their jobs working with radiation. Regulations limit the amount of 
radiation these workers can receive each year to make sure their risks are low. The added radiation dose you will 
receive from this study is less than the yearly regulatory limit set to protect radiation workers in the U.S. 
 
For more information about risks and side effects, ask one of the researchers or study staff. 
 
There may be unforeseeable side effects that could be life threatening or fatal (could cause death). 
 
IRB Approved Date: 4/6/2020


Title of Study: The Role of 68Ga PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer  
 
STU2019-1198, Rofsky, FormE-Consent-Main, Mod_2, 04-06-20 
 
 
Page 5 of 9 
                           
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DO NOT DISCLOSE 
We will tell you about any significant new findings which develop during the course of this research which may relate 
to your willingness to continue taking part. 
 
Are there Risks related to withdrawing from the study?  
 
If you decide to withdraw from this study early, please discuss your decision with the principal investigator.  The 
researcher may ask you to complete study withdrawal procedures at a final study visit. There is no risk to you if you 
do not complete the final withdrawal procedures and you can choose not to participate in them. 
 
Reproductive Risks – 
 
Concerns for sexually active men:  Men should not father a baby while taking part in this study because we do not 
know how the study drugs/procedures could affect a man's sperm  
 
 
Are there risks if you also participate in other research studies? 
Being in more than one research study at the same time, may increase the risk to you.  It may also affect the results 
of the studies.  You should not take part in more than one study without approval from the researchers.   
 
What if a research-related injury occurs?  
The researchers have taken steps to minimize the known or expected risks.  However, you may still experience 
problems or side effects, even though the researchers are careful to avoid them.  In the event of a research-related 
injury or if you experience an adverse reaction, please immediately contact your study doctor.  See the section “Contact 
Information” for phone numbers and additional information.  You may also need to tell your regular doctors. 
 
If you are injured or made sick from taking part in this research study, medical care will be provided. This care may 
be billed to you or your insurance. Depending on the circumstances, this care may be provided at no cost to you. We 
have no plans to give you money if you are injured. The investigator can provide you with more information. 
 
If you sign this form, you do not give up your right to seek additional compensation if you are harmed as a result of 
being in this study. 
 
Benefits – “How could you or others benefit from your taking part in this study?” 
 
The possible benefit of your participating in this study is to identify possible abnormalities that were not identified by 
standard of care imaging.  There is no guarantee or promise that you will receive any benefit from this study.   
 
We hope the information learned from this study will benefit other people with similar conditions in the future. 
 
Alternative procedures or course of treatment – “What other options are there to participation in this 
study?” 
 
There are other options available to you.  Your other choices may include: not participating in this study or an 
alternative one. 
 
Payments – Will there be any payments for participation? 
 
No, you will not receive payment for participation in this study. 
 
 
 
IRB Approved Date: 4/6/2020


Title of Study: The Role of 68Ga PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer  
 
STU2019-1198, Rofsky, FormE-Consent-Main, Mod_2, 04-06-20 
 
 
Page 6 of 9 
                           
UTSW Research Consent and Authorization Documents (v January 2019) 
 
DO NOT DISCLOSE 
Costs – Will taking part in this study cost anything? 
 
The sponsor will provide the 68Ga PSMA-11 PET/CT free of charge during this study. 
You or your health insurance company will be responsible for the cost of treatments and procedures that would be 
done whether or not you took part in this study, such as standard of care imaging of your tumor and therapy. It is 
important to understand that some insurance companies do not cover some costs (for example, approved drugs 
used in a way different from the package instructions). If your insurance company does not cover these treatments or 
procedures, you will be required to pay for them. 
 
Confidentiality – How will your records be kept confidential? 
 
Information we learn about you in this study will be handled in a confidential manner, within the limits of the law.  If 
we publish the results of the study in a scientific journal or book, we will not identify you.  The Institutional Review 
Board and other groups that have the responsibility of monitoring research may want to see study records which 
identify you as a subject in this study.    
 
Research policies require that private information about you be protected and this is especially true for your health 
information.  However, the law sometimes allows or requires others to see your information.  The information given 
below describes how your privacy and the confidentiality of your research records will be protected in this study. 
Medical information collected during this study and the results of any test or procedure that may affect your medical 
care may be included in your medical record. The information included in your medical record will be available to 
health care providers and authorized persons including your insurance company. 
What is Protected Health Information (PHI)?   
Protected Health Information is information about a person’s health that includes information that would make it 
possible to figure out whose it is.  According to the law, you have the right to decide who can see your protected 
health information.  If you choose to take part in this study, you will be giving your permission to the investigators and 
the research study staff (individuals carrying out the study) to see and use your health information for this research 
study.  In carrying out this research, the health information we will see and use about you will include:  
 
Your demographic information (age, race, marital status, occupation) 
 
Your medical history including your cancer diagnosis obtained from your medical record 
 
Your imaging studies and blood work obtained at your diagnosis 
 
Your treatment history 
We will get this information by asking you, asking your doctor, and reviewing your medical record at UT 
Southwestern.  
 
How will your PHI be shared?   
Because this is a research study, we will be unable to keep your PHI completely confidential.  We may share your 
health information with people and groups involved in overseeing this research study including: 
 
The Simmons Cancer Center Data Safety and Monitoring Board the committee that checks the study data on an 
ongoing basis, to determine if the study should be stopped for any reason. 
 
The members of the local research team. 
 
The Institutional Review Board, Human Research Protection Program Office and the Compliance Office of the 
University of Texas Southwestern Medical Center, and other groups that oversee how research studies are 
carried out.  
 
The Research offices at the University of Texas Southwestern Medical Center.  
 
The Food and Drug Administration (FDA) and other U.S. and international governmental regulatory agencies 
involved in overseeing drug or device research. 
 
Representatives of domestic and foreign governmental and regulatory agencies may be granted direct access to 
your health information for oversight, compliance activities, and determination of approval for new medicines, 
devices, or procedures.   
IRB Approved Date: 4/6/2020


Title of Study: The Role of 68Ga PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer  
 
STU2019-1198, Rofsky, FormE-Consent-Main, Mod_2, 04-06-20 
 
 
Page 7 of 9 
                           
UTSW Research Consent and Authorization Documents (v January 2019) 
 
DO NOT DISCLOSE 
 
If you decide to participate in this study, you will be giving your permission for the groups named above, to collect, 
use and share your health information.  If you choose not to let these groups collect, use and share your health 
information as explained above, you will not be able to participate in the research study. 
 
Parts of your PHI may be photocopied and sent to a central location or it may be transmitted electronically, such as 
by e-mail or fax. The groups receiving your health information may not be obligated to keep it private.  They may 
pass information on to other groups or individuals not named here. 
 
How will your PHI be protected?   
In an effort to protect your privacy, the study staff will use code numbers instead of your name, to identify your health 
information.  Initials and numbers will be used on any photocopies of your study records, and other study materials 
containing health information that are sent outside of the UT Southwestern Medical Center for review or testing. If the 
results of this study are reported in medical journals or at meetings, you will not be identified. 
 
Do you have to allow the use of your health information? 
You do not have to allow (authorize) the researchers and other groups to see and share your health information.  If 
you choose not to let the researchers and other groups use your health information, there will be no penalties, but 
you will not be allowed to participate in the study.   
After you enroll in this study, you may ask the researchers to stop using your health information at any time .  
However, you need to say this in writing and send your letter to Dr. Neil M. Rofsky, 5323 Harry Hines Blvd, Dallas, 
TX 75390.  If you tell the researchers to stop using your health information, your participation in the study will end 
and the study staff will stop collecting new health information from you and about you for this study.  However, the 
study staff will continue to use the health information collected up to the time they receive your letter asking them to 
stop. 
 
Can you ask to see the PHI that is collected about you for this study?   
The federal rules say that you can see the health information that we collect about you and use in this study.  
Contact the study staff if you have a need to review your PHI collected for this study.  
 
How long will your PHI be used?   
By signing this form, you agree to let us use and disclose your health information for purposes of the study until the 
end of the study.  This permission to use your personal health information expires when the research ends and all 
required study monitoring is over. 
 
Contact Information – Who can you contact if you have questions, concerns, comments or complaints? 
 
If you have questions now, feel free to ask us.  If you have additional questions, concerns, comments or complaints 
later or you wish to report a problem which may be related to this study please contact: 
Dr. Neil M. Rofsky at 214-648-7702 during normal business hours 
 
The University of Texas Southwestern Medical Center Human Research Protection Program (HRPP) oversees 
research on human subjects.  HRPP and Institutional Review Board (IRB) representatives will answer any questions 
about your rights as a research subject, and take any concerns, comments or complaints you may wish to offer.  You 
can contact the HRPP by calling the office at 214-648-3060. 
 
 
IRB Approved Date: 4/6/2020


Title of Study: The Role of 68Ga PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer  
 
STU2019-1198, Rofsky, FormE-Consent-Main, Mod_2, 04-06-20 
 
 
Page 8 of 9 
                           
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DO NOT DISCLOSE 
Research Consent & Authorization Signature Section 
If you agree to participate in this research and agree to the use of your protected health information in this research, 
sign this section.  You will be given a copy of this form to keep.  You do not waive any of your legal rights by signing 
this form. 
 
SIGN THIS FORM ONLY IF THE FOLLOWING STATEMENTS ARE TRUE: 
 
You have read (or been read) the information provided above. 
 
Your questions have been answered to your satisfaction about the research and about the collection, use and 
sharing of your protected health information. 
 
You have freely decided to participate in this research or you are voluntarily giving your consent for another 
person to participate in this study because you believe this person would want to take part if able to make the 
decision and you believe it is in this person’s best interest.   
 
You understand that a copy of this signed consent document, information about this study, and the results of 
any test or procedure that may affect your medical care, may be included in your medical record. Information 
in your medical record will be available to health care providers and authorized persons including your 
insurance company. 
 
You authorize the collection, use and sharing of your protected health information (another person’s 
protected health information) as described in this form. 
 
Adult Signature Section  
 
 
 
 
 
 
 
AM 
PM 
Printed Name of Participant 
 
 
 
Signature of Participant 
 
 
 
Date 
 
Time 
 
 
 
 
 
 
 
AM 
PM 
Printed Name of Person 
Obtaining Consent 
 
Signature of Person Obtaining Consent  
 
 
Date 
 
Time 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IRB Approved Date: 4/6/2020


Title of Study: The Role of 68Ga PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer  
 
STU2019-1198, Rofsky, FormE-Consent-Main, Mod_2, 04-06-20 
 
 
Page 9 of 9 
                           
UTSW Research Consent and Authorization Documents (v January 2019) 
 
DO NOT DISCLOSE 
Witness / Interpreter Signature Section   
 
Interpreter/witness (Interpreter signature required per hospital policies when physically present.)  
I attest that I have interpreted the information in this consent form and it was explained to, and apparently 
understood by the subject or the subject's legal authorized representative, and that informed consent was 
freely given by the subject or the subject’s legally authorized representative as indicated by their signature 
on the associated short form. 
 
 
 
 
 
 
AM 
PM 
Printed Name of Interpreter 
 
 
 
Signature of Interpreter 
 
 
Date 
 
Time 
 
 
Witness Signature (required when interpreter is not physically present-e.g., Language Line is used): 
By signing below: 
I attest that the information in the consent form was accurately explained to, and apparently understood by 
the subject or the subject's legal authorized representative, and that informed consent was freely given by 
the subject or the subject’s legally authorized representative as indicated by their signature on the 
associated short form. 
 
 
 
 
 
 
 
AM 
PM 
Printed Name of witness 
 
 
 
Signature of witness 
 
 
Date 
 
Time 
 
 
 
Blind or Illiterate Signature Section  At the time of consent, also complete this section if consent is obtained 
from an individual who is unable to read and/or write but can otherwise communicate and/or comprehend English 
(e.g., blind, physically unable to write, etc.)  
 
Declaration of witness: 
By signing below, I confirm I was present for the entire consent process. The method used for communication 
(e.g., verbal, written, etc.) with the subject was:                                      .   
 
The specific means (e.g., verbal, written, etc.) by which the subject communicated agreement to participate  
was:                                             .          
 
 
 
 
 
 
 
 
AM 
PM 
Printed Name of Witness 
 
 
Signature of Witness 
 
 
Date 
 
Time 
 
  
IRB Approved Date: 4/6/2020