Conditions: Prostate Cancer
Keywords: Prostate Cancer
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 14
Healthy volunteers: no

Brief summary:
The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.

Detailed description:
Primary Objective: To evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.

Exploratory Objective:

* Correlation of 68Ga PSMA 11 uptake and Gleason score at biopsy
* Correlation of 68Ga RM2 and Gleason score at biopsy

Arms:
arm 1: Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 arm 2: Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2

Interventions: intervention 1: 68Ga RM2 intervention 2: 68Ga-PSMA-11 intervention 3: Investigational PET scanner coils and software
Intervention descriptions: intervention 1: PET radiopharmaceutical intervention 2: PET radiopharmaceutical intervention 3: GE Healthcare non-approved PET scanner coils and software

Protocol document:
Prot_001.pdf: 
IRB-48151 
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CONFIDENTIAL 
Protocol version 2;  15 November 2021 
A Pilot Study of 68Ga-PSMA-11 PET/MRI and 68Ga-RM2 PET/MRI for 
Biopsy Guidance in Patients with Suspected Prostate Cancer 
Principal Investigator / Protocol Director  
Andrei Iagaru, MD 
300 Pasteur Dr, 
 
Stanford, CA 94305 
Phone:  650-725-4711 
Fax:  650-498-5047 
Email:  aiagaru@stanford.edu  
Co-investigators 
Bruce Daniel, MD, PhD 
300 Pasteur Dr;  
  
Stanford, CA 94305  
Phone:  650-725-1812 / Fax:  
 
Email:  bdaniel@stanford.edu 
Pejman Ghanouni, MD, PhD 
1201 Welch Road, 
 
Stanford, CA 94305  
Phone:  650-498-4485 / Fax:  
 
Email:  ghanouni@stanford.edu 
Geoffrey Sonn, MD 
875 Blake Wilbur Dr;  
  
Stanford, CA  94305  
Phone:  
 / Fax:  
 
Email:  gsonn@stanford.edu 
Guido Davidzon, MD 
300 Pasteur Dr, 
 
Stanford, CA  94305  
Phone:  650-725-4711 / Fax: 650-498-5047 
Email:   gdavidzon@stanford.edu 
Carina Mari Aparici, MD 
300 Pasteur Dr, 
 
Stanford, CA  94305  
Phone:  650-725-4711 / Fax:  650-498-5047 
Email:  drmari@stanford.edu 
Study Coordinator  
 
800 Welch Rd 
Palo Alto, CA 94304 
Phone:  
 / Fax:  
 
Email:  
  
 
Protocol IRB-48151  //   PROS0091  //  NCT03809078 
Protocol Version 2  //  15 November 2021 
 


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Table of Contents 
PROTOCOL SYNOPSIS ..........................................................................................................4 
SCHEMA ..............................................................................................................................5 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ..........................................6 
1. OBJECTIVE .................................................................................................................7 
2. BACKGROUND ...........................................................................................................7 
2.1 Preliminary information ................................................................................................ 7 
2.2 Clinicaltrials.gov ............................................................................................................ 8 
2.3 Rationale ........................................................................................................................ 9 
2.4 Study Design ............................................................................................................... 10 
2.4.1 Objectives of the Study .......................................................................................... 11 
2.4.2 Endpoints .................................................................................................................. 11 
2.4.3 ClinicalTrials.gov Outcomes .................................................................................. 11 
3. PARTICIPANT SELECTION AND ENROLLMENT PROCEDURES ...................... 12 
3.1 Inclusion Criteria ......................................................................................................... 12 
3.2 Exclusion Criteria ........................................................................................................ 12 
3.3 Informed Consent Process ........................................................................................ 12 
3.4 Study Timeline............................................................................................................. 12 
4. IMAGING AGENT INFORMATION .......................................................................... 12 
4.1 Study Agents ............................................................................................................... 12 
4.2 Source of the Study Agent ........................................................................................ 14 
4.3 Ordering ....................................................................................................................... 14 
4.4 Agent Accountability ................................................................................................... 14 
5. IMAGING SPECIFICS ............................................................................................... 14 
5.1 Modality or Modalities to be used ............................................................................. 14 
5.2 Details of Imaging (ie, dynamic, static, number of scans, etc) ............................. 14 
5.3 Image interpretation .................................................................................................... 15 
6. STUDY PROCEDURES ............................................................................................ 15 
6.1 Pre-Study ..................................................................................................................... 15 
6.2 Imaging Days............................................................................................................... 15 
6.3 Follow-up ...................................................................................................................... 15 
6.4 Criteria for Removal from Study................................................................................ 16 
6.5 Alternatives ................................................................................................................... 16 
7. STUDY CALENDAR ................................................................................................. 16 
8. ADVERSE EVENTS AND REPORTING PROCEDURES ....................................... 16 
8.1 Potential Adverse Events .......................................................................................... 16 
8.2 Adverse Event Reporting .......................................................................................... 17 
9. REGULATORY CONSIDERATIONS ....................................................................... 17 
9.1 Institutional Review of Protocol ................................................................................ 17 
9.2 Data Management Plan ............................................................................................. 17 
10. Statistical Considerations and Evaluation of Results ........................................ 18 
10.1 Study Endpoints ........................................................................................................ 18 
10.2. 
Accrual estimates ................................................................................................ 18 


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10.3 Analyses Plans ......................................................................................................... 18 
10.4 Accrual estimates ..................................................................................................... 18 
11. REFERENCES: ............................................................................................................... 19 
 


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PROTOCOL SYNOPSIS 
TITLE 
A Pilot Study of 68Ga-PSMA-11 PET/MRI and 68Ga-RM2 
PET/MRI for Biopsy Guidance in Patients with Suspected 
Prostate Cancer 
STUDY PHASE 
Phase 2 pilot study 
INDICATION 
Prostate cancer 
INVESTIGATIONAL 
PRODUCTS  
68Ga-PSMA-11;  also known as: 
• DFKZ-11 
• HBED-CC PSMA 
• The “Heidelberg compound” 
68Ga-RM2;  also known as: 
• Bombesin 
• BAY86-7548 
SAMPLE SIZE  
20 participants 
PRIMARY OBJECTIVE 
To evaluate 68Ga-PSMA-11 PET/MRI and 68Ga-RM2 PET/MRI 
for biopsy guidance in patients with suspected prostate cancer. 
EXPLORATORY 
ENDPOINTS 
• Correlation of 68Ga-PSMA-11 uptake and Gleason score at 
biopsy 
• Correlation of 68Ga-RM2 and Gleason score at biopsy 


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SCHEMA 
 
 
 
Eligible participant with suspected prostate cancer 
68Ga-PSMA11 PET/MRI 
Followed within 2 weeks by 
 68Ga-RM2 PET/MRI 
OR 
68Ga-RM2 PET/MRI 
Followed within 2 weeks by 
 68Ga-PSMA11 PET/MRI 
Prostate biopsy 


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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
Ga-68;  68Ga 
Gallium-68 
IRB 
Institutional Review Board 
IV 
Intravenous 
MRI 
Magnetic resonance imaging 
NPV 
Negative predictive value  
PPV 
Positive predictive value  
PET 
Positron emission tomography 
SUV 
Standardized Uptake Value 
PSMA 
Prostate-specific membrane antigen 
GRPR 
Gastrin releasing peptide receptor 
PRCA 
Prostate cancer 
 


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1. OBJECTIVE 
Specific Aim 
To evaluate 68Ga-PSMA-11 PET/MRI and 68Ga-RM2 PET/MRI for biopsy guidance in patients 
with suspected prostate cancer. 
2. BACKGROUND 
2.1 Preliminary information 
Prostate cancer (PRCA) kills ~29,000 American men each year (1).  However, most of the 
~180,000 new cases diagnosed each year are not deadly.  While the 50% drop in PRCA 
specific mortality in the US occurred concurrently with systematic PSA screening starting in the 
1980s, the PLCO randomized trial of PSA screening showed no survival benefit, and ERSPC in 
Europe showed a small but positive benefit to PSA screening (2, 3).  Two significant limitations 
of PSA testing contribute to the poor results of these trials and form the basis of this proposal: 
 
The 1st limitation is that PSA has poor sensitivity and specificity with ~15% of men with PRCA 
having a normal PSA (4) while 60-80% of men who are biopsied are found to have no cancer, 
either because there is none and the PSA test was falsely positive or the cancer is missed by 
the biopsy (5).  Until recently, transrectal ultrasound (TRUS) has been the only widely available 
used imaging modality.  Because of the major limitations of TRUS for PRCA detection, 
diagnosis is most commonly accomplished by systematically sampling the entire prostate using 
12 needles passed through the rectum under TRUS guidance, rather than directing biopsy to 
any particular target seen in the gland on TRUS images.  This biopsy procedure can be painful 
and is associated with significant and increasing rates of infectious complications (6, 7).  Since 
autopsy studies show that many men have small, indolent cancers that are not likely to be life 
threatening (8), PSA driven biopsy leads to overdiagnosis of indolent cancers (9) that are not 
clinically significant.  The ideal approach would be to eliminate unnecessary biopsies in men 
with no cancer or indolent cancer, and selectively biopsy men with aggressive cancers who are 
more likely to benefit from therapy. 
 
The 2nd limitation is that PSA screening and biopsies miss a significant number of aggressive 
cancers, either by under-sampling high grade cancers, or by underestimating of tumor volume 
(10-12).  The ideal approach would be to direct biopsies towards the areas of most aggressive 
tumor, so that biopsy accurately reflects the severity of their disease. 
 
In response to these shortcomings of PSA screening as well as the significant treatment 
associated side effects (13), the management of localized PRCA has changed dramatically in 
the past 5 years to directly address the problem of over-treatment (5).  One of the greatest 
changes has been the increased use of Active Surveillance (AS) in men with low grade, low risk 
PRCA (14).  In the US, rates of AS have increased from 5-9% in 1990-2010 to 40%, while in 
Europe, rates are 80 to 90% (15-17).  Gleason scoring is an established marker of outcome and 
is the most important factor used in selecting patients for AS (5).  Low grade cancers (Grade 
group 1 or Gleason score 3 + 3 + 6) are recommended for AS, while cases > 3 + 4 (or in some 
cases > 4 + 3) are recommend for definitive therapy (18).  Therefore, accurate identification of 
cases with grade > 3 + 4 is critical for determining initial treatment vs AS.  Second, ancillary 
tests, such as the urinary test PCA3 (a lncRNA over-expressed in PRCA), as well as the 


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Prostate Health Index and 4Kscore have emerged (both assessing molecular forms of PSA) 
(19-21).  These tests have been calibrated to identify men who do not need biopsy, and can 
decrease biopsy rates by 10-20%.  However, many unnecessary biopsies continue to occur, 
and none of these tests effectively identifies aggressive PRCA.  For example, neither the PCA3 
or 4K score provide clinically meaningful prediction of outcomes in men on AS and cannot be 
used in clinical decision-making in this large and growing cohort of men (22, 23).  New 
technologies are critically needed to eliminate unnecessary biopsies in men with no cancer or 
indolent cancer, and to better identify men with aggressive forms (≥ 3 + 4) of PRCA. 
 
Recently, novel PET tracers that target PRCA cells have emerged as promising methods to 
improve PRCA imaging.  PET tracers such as 18F- or 11C-labeled choline and 11C-acetate are 
used at selected institutions in the USA (24, 25) but uptake in benign prostatic 
hyperplasia (BPH) or inflammatory lymph nodes (26, 27) limits their clinical utility.  A new 
synthetic amino acid 18F-FACBC suffers from limited specificity as its uptake in PRCA is 
reported to be similar to that in BPH (28).  Prostate-specific membrane antigen (PSMA) is a cell 
surface protein significantly over-expressed in PRCA cells, and anti-PSMA antibodies labeled 
with 68Ga and 18F-labeled radiotracers can detect PRCA relapses and metastases by binding to 
the extracellular domain of PSMA.  While PSMA appears to be a very promising molecular 
imaging target (29, 30), it does not detect all recurrences (31, 32) and is not specific to PRCA 
only (33, 34).  False positives have also been reported (35-37).  Gastrin releasing peptide 
receptor (GRPR) has emerged as a novel imaging target which is also highly expressed in 
PRCA and has much lower expression in benign prostate tissue including BPH and 
inflammation (38).  This high specificity provides an advantage over current choline- and 
acetate-based radiotracers.  GRPR can be targeted by its natural ligand GRP or other 
bombesin-like peptides.  Compared to antibodies, peptides are usually cleared faster, penetrate 
tissue more rapidly, show lower antigenicity, and can be synthesized in large quantities 
relatively easily, making GRPR an attractive target (39).  Also, a clear difference of RM2 
expression level between Gleason patterns 3 and ≥ 4 has been shown with higher expression of 
RM2 antigen significantly associated with primary Gleason pattern ≥ 4, high Gleason 
score (≥ 8), larger tumor volume, and advanced tumor stage (40).  Furthermore, 5-year PSA 
failure-free survival was significantly lower in the higher expression groups (40).   
 
The sponsor-investigator Dr Iagaru holds Investigational New Drug applications (INDs) for both 
68Ga-RM2 and 68Ga-PSMA-11 (IND 
 and IND 
, respectively) and the group has 
significant experience using both tracers in currently ongoing clinical studies at our institution. 
To improve the performance of MRI imaging in the prostate, one possible solution could be to 
combine molecular imaging strategies.  MRI provides excellent soft tissue contrast and mpMRI 
has significantly improved PRCA detection in the prostate.  PET/MRI can increase the 
specificity of MRI alone when using PRCA specific PET tracers (41).  We propose testing this 
multimodal imaging platform in patients with early stage PRCA to understand its performance 
characteristics for detection, particularly for aggressive disease (defined as high grade > 3 + 4). 
2.2 Clinicaltrials.gov  
This protocol will be registered on Clinicaltrials.Gov.  ClinicalTrials.gov outcomes are described 
in Section 2.4.3.  


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2.3 Rationale
In this study, we propose to use a well-established PET isotope, Gallium-68 (68Ga), bound to a 
PSMA ligand (ie, 68Ga-PSMA-11) and a GRPR ligand (ie, 68Ga-RM2) that have high affinity for 
prostate specific membrane antigen and gastrin releasing peptide receptors, respectively.  
Therefore, we propose the following aim: to evaluate 68Ga-PSMA-11 PET/MRI and 68Ga-RM2 
PET/MRI for biopsy guidance in patients with suspected prostate cancer.
We have an ongoing protocol at Stanford University evaluating 68Ga-PSMA-11 PET/MRI for 
evaluation of extent of disease in patients with intermediate or high-risk prostate cancer 
scheduled to undergo prostatectomy and nodal dissection.  Our initial analysis of the first 
33 participants showed that prostate cancer was seen using 68Ga-PSMA-11 PET in all patients, 
whereas multiparametric MR imaging depicted Prostate Imaging Reporting and Data 
System (PI-RADS) 4 or 5 lesions in 26 patients and PI-RADS 3 lesions in four patients.  Focal 
uptake was seen in the pelvic lymph nodes in five patients.  Pathologic examination confirmed 
prostate cancer in all patients, as well as nodal metastasis in three.  All patients with normal 
pelvic nodes in PET/MR imaging had no metastases at pathologic examination (42).  
Figure 1:  74 year-old man (participant #4) with recently diagnosed intermediate risk, T1c, Gleason 
4+4 prostate cancer presenting with PSA of 4.12 ng/mL.  Maximum intensity projection (MIP) PSMA 
11 PET image (A), early transaxial PET (B) and delayed transaxial PET (C) showed focal uptake in 
histopathological proven prostate cancer (F).  The milder focal uptake in the left lobe was likewise 
proven to be prostate cancer.  Transaxial T2-weighted MRI (D) and DWI (B = 800) MRI (E) are also 
shown.  Only the right-side tumor was mpMRI positive (PI-RADS 5).
In addition, we now have pilot data from 12 participants with intermediate or high-risk 
prostate cancer scheduled to undergo prostatectomy and nodal dissection who had 
68Ga-RM2 PET/CT prior to surgery. Prostate cancer was identified in all 12 patients.


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Figure 2:  68 year-old man (participant #2) with recently diagnosed intermediate risk, T1c, Gleason 
3+4 prostate cancer presenting with PSA of 4.53 ng/mL.  Maximum intensity projection (MIP) RM2 
PET image (A), transaxial PET (B) and fused transaxial PET (C) showed focal uptake in 
histopathological proven prostate cancer (D).
2.4 Study Design
This is a pilot study with a total of 20 participants with suspected prostate cancer.  All patients 
will first be seen by a Stanford Cancer Institute physician and then referred if appropriate on 
clinical grounds to Dr Iagaru or his colleagues for this study.  Eligible participants will undergo 
baseline assessments at enrollment.  The following steps will take place after the participant has 
signed the written consent (participants will be randomized to have 68Ga-RM2 first followed by 
68Ga-PSMA11 within 2 weeks or 68Ga-PSMA11 first followed by 68Ga-RM2 within 2 weeks 
[50/50 chance for each schedule]).
1. Participants will be given a copy of the consent form s/he signed. 
2. Participant will be asked to drink 1 to 2 glasses of water before arrival at the clinic
3. Vital signs (heart rate, blood pressure) will be recorded
4. Participant will be injected IV with 140 ± 20% mBq of 68Ga-RM2
5. Participant will void immediately prior to the scan
6. Approximately 45 minutes after the radiopharmaceutical IV administration, data 
acquisition will begin in the pelvic region and move toward the head.  First, localizer MRI 
scans will be performed to define the table positions.  After correct positioning of the 
spatial acquisition windows is ensured, the combined PET/MRI acquisition will be 
initiated with 3 to 5 table positions at a 2 to 4 minute acquisition time per table position.
7. Vital signs (heart rate, blood pressure) will be recorded again at the completion of the 
study, and the participant will be dismissed.


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8. Participants will be contacted at 24 to 72 hours following the scan in order to collect any 
adverse events. 
The same will be repeated for 68Ga-PSMA11 (within 2 weeks of 68Ga-RM2): 
1. Participant will be asked to drink 1 to 2 glasses of water before arrival at the clinic 
2. Vital signs (heart rate, blood pressure) will be recorded 
3. Participant will be injected IV with 3 to 7 mCi of 68Ga-PSMA11 
4. Participant will void immediately prior to the scan 
5. Approximately 45 to 60 minutes after the radiopharmaceutical IV administration, data 
acquisition will begin in the pelvic region and move toward the head.  First, localizer MRI 
scans will be performed to define the table positions.  After correct positioning of the 
spatial acquisition windows is ensured, the combined PET/MRI acquisition will be 
initiated with 3 to 5 table positions at a 2 to 4 minute acquisition time per table position.  
Only MR sequences required for attenuation correction of PET data will be acquired. 
6. Vital signs (heart rate, blood pressure) will be recorded again at the completion of the 
study. 
7. Participants will be contacted at 24 to 72 hours following the scan in order to collect any 
adverse events. 
 
2.4.1 Objectives of the Study 
Primary 
• 
To evaluate 68Ga-PSMA-11 PET/MRI and 68Ga-RM2 PET/MRI for biopsy guidance in 
patients with suspected prostate cancer. 
Exploratory 
• 
Correlation of 68Ga-PSMA-11 uptake and Gleason score at biopsy 
• 
Correlation of 68Ga-RM2 and Gleason score at biopsy 
 
2.4.2 Endpoints 
Primary Endpoints 
• 
Number of participants with successful PET-based biopsy guidance  
Exploratory Endpoints 
• 
Observation of SUVmax from 68Ga-PSMA-11 uptake and Gleason score at biopsy 
• 
Observation of SUVmax from 68Ga-RM2 uptake and Gleason score at biopsy 
 
2.4.3 ClinicalTrials.gov Outcomes 
Primary Outcome 
Title:  Successful PET-based Biopsy Guidance  
Description:  Number of participants with biopsy results correlated with imaging findings 
(ie, prostate uptake on 68Ga-PSMA-11 and 68Ga-RM2 scans) 
The outcome will be reported as the number of participants without dispersion for which 
PET-based biopsy guidance is successfully obtained.  
Timeframe:   
Safety outcome:  No 
 


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Protocol version 2;  15 November 2021 
Secondary Outcome 
None.  
 
3. PARTICIPANT SELECTION AND ENROLLMENT PROCEDURES 
3.1 Inclusion Criteria 
• 
≥ 18 years-old 
• 
Suspected prostate cancer 
• 
Planned prostate biopsy 
• 
Able to provide written consent 
• 
Karnofsky performance status of ≥ 50 (or ECOG/WHO equivalent) 
3.2 Exclusion Criteria 
• 
Patients not capable of getting PET study due to weight, claustrophobia, or inability 
to lay still for the duration of the exam 
• 
Metallic implants (contraindicated for MRI) 
 
3.3 Informed Consent Process 
All participants will be provided a consent form describing the study with sufficient information 
for participants to make an informed decision regarding their participation.  Participants must 
sign the IRB-approved informed consent prior to participation in any study specific procedure.  
The participant must receive a copy of the signed and dated consent document.  The original 
signed copy of the consent document must be retained in the medical record or research file.   
 
3.4 Study Timeline 
3.4.1 Primary Completion: 
The study will reach primary completion 24 months from the time the study opens to accrual. 
3.4.2.  Study Completion: 
The study will reach study completion 36 months from the time the study opens to accrual. 
4. IMAGING AGENT INFORMATION 
4.1 Study Agents  
This protocol will utilize 68Ga-RM2 and 68Ga-PSMA11 as radioimaging agents.   
4.1.1 68Ga-RM2  
The PET radiopharmaceutical 68Ga-RM2 has previously been identified as 
68Ga-DOTA Bombesin or BAY86-7548.  This is not an FDA-approved product,and is described 
within IND 
, the IND to which this protocol is submitted.  The structure of 68Ga-RM2 is 
represented in Figure 3. 


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Protocol version 2;  15 November 2021 
 
Figure 3:  Chemical structure of 68Ga-RM2 
 
The administered dosage of 68Ga-RM2 will be 140 mBq ± 20%, administered IV.  Measured 
human dosimetry data are available from published data (47).  68Ga-RM2 is rapidly excreted 
through the kidneys to the urinary bladder and accumulated predominantly in the pancreas and 
liver.  Maximum peak uptake of the total injected radioactivity was seen in the urinary bladder 
contents and the liver, with approximately 36% and 14%, respectively. 
 
The organ with the highest absorbed dose was the urinary bladder wall at 0.61 mSv/MBq, 
followed by the pancreas at 0.51 mSv/MBq.  The mean effective dose (14) was 
0.051 mSv/MBq.  Thus, the effective dose from a 140-MBq injected radioactivity is 7.7 mSv, 
which could be reduced to roughly 4.76 mSv with frequent bladder voiding (1-hr voids). 
To summarize the results of the published human dosimetry study, there were no observed 
adverse events to the radiopharmaceutical.  The measured dosimetry showed that the critical 
organ with 68Ga-RM2 is the urinary bladder, followed by the pancreas.  The effective dose of 
68Ga-RM2 reported (0.051 mSv/MBq) is approximately twice as much as those of 
68Ga-DOTA-TOC (0.023 mSv/MBq), 68Ga-DOTA-NOC (0.025 mSv/MBq), 68Ga-DOTA-TATE 
(0.021 mSv/MBq) and 68Ga-NOTA-RGD (0.022 mSv/MBq) (43-46). 
 
4.1.2 68Ga-PSMA11  
The PET radiopharmaceutical 68Ga-PSMA11 will also be utilized, and has previously been 
identified as DFKZ-11;  HBED-CC PSMA;  or the “Heidelberg compound.”  This is not an 
FDA-approved product, and is described within IND 
, which is cross-referenced to 
IND 
.  The structure of 68Ga-PSMA11 is represented in Figure 4. 
 
Figure 4:  Chemical structure of 68Ga-PSMA11.  
 


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The administered dosage of 68Ga-PSMA-11 will be 111 to 259 mBq (3 to 7 mCi), administed IV.  
There are 2 publications on dosimetry for 68Ga-PSMA-11 (PMID:  27260521;  28012435).  The 
first lists 0.0236 mSv/MBq for the mean effective dose, while the other indicates 
0.0258 mSv/MBq.  We used the maximum potential administered activity of 7 mCi and the 
higher of the reported dosimetry values.  Therefore, 259 mBq x 0.0258 mSv/MBq + 6.68 mSv. 
 
To summarize the results of the published human studies, there were no observed adverse 
events to the radiopharmaceutical.  The measured dosimetry showed that the critical organ with 
68Ga-PSMA-11 is the spleen, followed by the stomach wall;  pancreas;  and bladder wall.  The 
effective dose of 68Ga-PSMA-11 reported (0.0258 mSv/MBq) is similar to 
those of 68Ga-DOTA-TOC (0.023 mSv/MBq), 68Ga-DOTA-NOC (0.025 mSv/MBq), 
68Ga-DOTA-TATE (0.021 mSv/MBq) and 68Ga-NOTA-RGD (0.022 mSv/MBq) (43-46).   
 
4.2 Source of the Study Agent  
Molecular Imaging Program at Stanford (MIPS) 
Satellite Radiochemistry Facility  
300 Pasteur Dr, C21 
Stanford, CA 94305  
 
4.3 Ordering 
Ordered in Radiology Information System (RIS), address per above. 
 
4.4 Agent Accountability 
The RIS is password-protected and part of the electronic medical records. 
5. IMAGING SPECIFICS  
5.1 Modality or Modalities to be used 
PET/MRI 
 
5.2 Details of Imaging (ie, dynamic, static, number of scans, etc) 
A localizer MRI scan will be performed at 45 minutes after injection of 140 mBq of 68Ga-RM2 (or 
3 to 7 mCi of 68Ga-PSMA11, depending on randomization) to define the table positions.  After 
correct positioning of the spatial acquisition windows is ensured, the combined PET/MRI 
acquisition will be initiated with 3 to 5 table positions at a 2 to 4 minute acquisition time per table 
position.  A volumetric T1 acquisition with fat-water separation and motion correction to enable 
free-breathing will be obtained at each table position and used for the generation of attenuation 
maps and for anatomic allocation of the PET results.  Simultaneously with the start of the 
T1 MRI sequence, the PET acquisition will start at the same table position, thus ensuring 
optimal temporal and regional correspondence between MRI and PET data.  The PET 
acquisition time will be 4 minutes per table position, taking delayed acquisition times and 
radioactive decay into account.  As the T1 will take less than 4 minutes, a rapid diffusion 
weighted MRI will also be performed.  After completion of the PET acquisition, the table will be 
moved to the next table position and the procedure will be repeated.  Upon completion of the 


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PET acquisition for all stations, volumetric post-contrast T1- and T2-weighted MR images may 
be obtained at multiple stations as needed. 
 
A localizer MRI scan will be performed at 45 minutes after injection of 3-7 mCi of 
68Ga-PSMA11 (or 68Ga-RM2, depending on randomization)  to define the table positions.  After 
correct positioning of the spatial acquisition windows is ensured, the combined PET/MRI 
acquisition will be initiated with 3 to 5 table positions at a 2 to 4 minute acquisition time per table 
position.  Only MR sequences required for attenuation correction of PET data will be acquired. 
Participants will be randomized to have 68Ga-RM2 first followed by 68Ga-PSMA11 within 
2 weeks or 68Ga-PSMA11 first followed by 68Ga-RM2 within 2 weeks (50/50 chance for each 
schedule). 
 
5.3 Image interpretation 
The PET/MRI scans will be interpreted by ABNM certified Nuclear Medicine physicians and an 
ABR-certified radiologists.  Drs Iagaru, Daniel, Davidzon, and Ghanouni have significant clinical 
experience and will be blinded to the participants’ medical history and the results of other 
imaging modalities.  Consensus read will be obtained for each scan.  Each lesion will be 
tabulated and a comparison of lesion detection by each tracer will be conducted. 
 
The study team will communicate the results of the scans to the referring (treating) physicians.  
Additional imaging/biopsy may be performed as a result of the research scan data. 
 
PET and MRI data will be imported in the biopsy device to assist with lesion localization during 
the biopsy procedure. 
6. STUDY PROCEDURES  
6.1 Pre-Study 
Potential subjects will be referred by treating physicians for participation in this imaging study.  
The following procedures will occur pre-study: 
• 
Review of eligibility criteria 
• 
Obtain informed consent 
• 
Collect demographics 
• 
Review medical history, including any concomitant medication.   
 
6.2 Imaging Days 
Subjects will undergo 2 separate clinic visits for imaging.  On each imaging day, subjects will 
receive an intravenous (IV) injection of investigational imaging agent (68Ga-RM2 or 
68Ga-PMSA11) and undergo PET/MRI image collection as described above.   
 
6.3 Follow-up 
Active subject participation ends after the 24 to 72 hour post-scan Safety Follow-up.  
Investigators will follow subjects by chart review for 12 months post-scan to record any standard 
of care biopsies or imaging results.  The investigators will assist with identification of lesions that 
can be biopsied, based on 68Ga-RM2 and/or 68Ga-PMSA11 PET/MRI findings. 


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If a subject transfers clinical care outside of Stanford Healthcare during the chart review clinical 
follow-up period, investigators will request permission to contact the treating physician. 
 
6.4 Criteria for Removal from Study 
The Protocol Director may withdraw subjects from the study for one or more of the following 
reasons:  failure to follow the instructions of the Protocol Director and/or study staff;  
determination that continuing the participation could be harmful to the subject;  the study is 
cancelled or other administrative reasons.   
 
6.5 Alternatives 
The alternative is to not participate in the study.   
 
7. STUDY CALENDAR 
 
Pre-Study 
Scan Date 
24 to 72 Hours 
Post-Scan 
12 Months 
Informed consent 
X 
 
 
 
Demographics 
X 
 
 
 
Medical history 
X 
 
 
 
68Ga-RM2 
 
X a 
 
 
68Ga-PSMA11 (within 2 weeks) 
 
X a 
 
 
Follow-up Call to Participant 
 
 
X 
 
Chart review b 
 
 
 
X 
a. Subjects will undergo either 68Ga-RM2 PET/MRI followed within 2 weeks by 68Ga-PMSA11 
PET/MRI, or 68Ga-PMSA11 PET/MRI followed within 2 weeks by 68Ga-RM2 PET/MRI 
b. Subjects will be followed by chart review for 12 months from initial scan date.  If a subject 
transfers clinical care from Stanford Healthcare, investigators may request records from the 
treating physician 
8. ADVERSE EVENTS AND REPORTING PROCEDURES 
8.1 Potential Adverse Events 
The administration of the radioactive substance will feel like a slight pinprick when given by 
IV injection.  Patients who are claustrophobic may feel some anxiety while positioned in the 
scanner.  Also, some patients find it uncomfortable to hold one position for more than a few 
minutes.  The subjects will not feel anything related to the radioactivity of the substance in their 
body.  Because the radioactivity is very short-lived, the radiation exposure is low.  The 
substance amount is so small that it does not affect the normal processes of the body.   
 
This research study involves exposure to radiation from one 68Ga-PSMA-11 PET/MRI.  There is 
no radiation exposure from MRI.  The effective dose from one typical maximum of 
259 mBq (range:  3 to 7 mCi) administration of 68Ga-PSMA-11 is 6.68 mSv.  Therefore, the 
effective dose from one 68Ga-PSMA-11 PET/MRI is 6.68 mSv, approximately equal to 13% of 
the limit that radiation workers (eg, a hospital X-ray technician) are allowed to receive in 1 year.   


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This research study also involves exposure to radiation from one 68Ga-RM2 PET/MRI.  There is 
no radiation exposure from MRI.  The amount of radiation from one administration of 140 mBq 
of 68Ga-RM2 is 4.76 mSv.  Therefore, the effective dose from one 68Ga-RM2 PET/MRI is 
4.76 mSv, approximately equal to 10% of the limit that radiation workers (eg, hospital x-ray 
technician) are allowed to receive in one year. 
 
8.2 Adverse Event Reporting 
We do not anticipate hazardous situations for the subjects as a result of this protocol.  However, 
standard of care procedures will be in place for verification of correct radiopharmaceutical dose 
and route of administration.  The study Principal Investigator (PI) or his designee will report all 
serious adverse events (per 21CFR§312.32) to the Stanford CCTO Safety Coordinator within 
10 working days of becoming aware of the event (5 days if the event is life-threatening or 
resulted in death) using the Adverse Events Communication Form.  If the principal investigator 
determines the unanticipated adverse effect presents an unreasonable risk to subjects, the 
study will be terminated as soon as possible, but no later than 5 working days after the PI 
makes the determination and no later than 15 working days after first receiving notification of the 
effect.   
9. REGULATORY CONSIDERATIONS 
9.1 Institutional Review of Protocol 
The protocol, the proposed informed consent and all forms of participant information related to 
the study (eg, advertisements used to recruit participants) will be reviewed and approved by the 
Stanford IRB.  Any changes made to the protocol will be submitted as a modification and will be 
approved by the IRB prior to implementation.  The Protocol Director will disseminate the 
protocol amendment information to all participating investigators.   
 
9.2 Data Management Plan 
The CRFs will be stored in a locked office in the Nuclear Medicine clinic.  Records will be kept 
using OnCore.   
 
During the clinical investigation, the Protocol Director will evaluate the progress of the trial, 
including periodic assessments of data quality and timeliness, participant recruitment, accrual 
and retention, participant risk versus benefit, performance of trial sites, and other factors that 
can affect study outcome.  Monitoring of the trial will occur every 8 weeks and a record of 
monitoring activities will be maintained by the study team.   
 
The Stanford Cancer Institute Data and Safety Monitoring Committee (DSMC) will audit study 
related activities to determine whether the study has been conducted in accordance with the 
protocol, local standard operating procedures, FDA regulations, and Good Clinical 
Practice (GCP). This may include review of regulatory binders, case report forms, eligibility 
checklists, and source documents.  In addition, the DSMC will regularly review serious adverse 
events and protocol deviations associated with the research to ensure the protection of human 
subjects.  Results of DSMC audits will be communicated to the IRB and the appropriate 
regulatory authorities at the time of continuing review, or in an expedited fashion, as needed.  


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10. Statistical Considerations and Evaluation of Results 
10.1 Study Endpoints 
Primary endpoint:   
• 
Number of participants with successful PET-based biopsy guidance  
Exploratory endpoints:   
• 
Observation of SUVmax from 68Ga-PSMA-11 uptake and Gleason score at biopsy 
• 
Observation of SUVmax from 68Ga-RM2 uptake and Gleason score at biopsy 
10.2. Accrual estimates 
 
We anticipate enrolling 20 patients in total.   
10.3 Analyses Plans 
 
This is a pilot study that will not have a pre-defined analysis plan.   
10.4 Accrual estimates 
 
We expect the accrual of 10 patients each year for 2 years.  This is achievable given our 
experience with other protocols and the support from the referring physicians, Drs Chung, Sonn, 
Brooks, and Gill.   


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22. Lin DW, Newcomb LF, Brown MD, et al.  Evaluating the Four Kallikrein Panel of the 4Kscore for 
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29. Dietlein M, Kobe C, Kuhnert G, et al.  Comparison of [18F]DCFPyL and [68Ga]Ga-PSMA-HBED-CC 
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30. Eiber M, Maurer T, Souvatzoglou M, et al.  Evaluation of Hybrid 68Ga-PSMA Ligand PET/CT in 248 
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31. Eiber M, Maurer T, Souvatzoglou M, et al.  Evaluation of hybrid 68Ga-PSMA ligand PET/CT in 248 
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33. Sathekge M, Lengana T, Modiselle M, et al.  68Ga-PSMA-HBED-CC PET imaging in breast 
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34. Rhee H, Blazak J, Tham CM, et al.  Pilot study:  use of gallium-68 PSMA PET for detection of 
metastatic lesions in patients with renal tumour.  EJNMMI Res.  2016;6:76. 
35. Hermann RM, Djannatian M, Czech N, Nitsche M.  Prostate-specific membrane antigen PET/CT:  
false-positive results due to sarcoidosis? Case Rep Oncol.  2016;9:457-63. 
36. Sasikumar A, Joy A, Nanabala R, Pillai MR, T AH.  68Ga-PSMA PET/CT false-positive tracer uptake 
in Paget disease.  Clin Nucl Med.  2016;41:e454-5. 
37. Noto B, Vrachimis A, Schafers M, Stegger L, Rahbar K.  Subacute stroke mimicking cerebral 
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39. Ananias HJK, van den Heuvel MC, Helfrich W, de Jong IJ.  Expression of the gastrin-releasing 
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44. Pettinato C, Sarnelli A, Di Donna M, et al.  68Ga-DOTANOC:  biodistribution and dosimetry in 
patients affected by neuroendocrine tumors.  Eur J Nucl Med Mol Imaging.  2008;35(1):72-9. 
45. SandstrÃƒm M, Velikyan I, Garske-Román U, et al.  Comparative Biodistribution and Radiation 
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Inclusion/Exclusion Criteria Checklist 
 
Protocol Title: 
A Pilot Study of 68Ga-PSMA-11 PET/MRI and 68Ga-RM2 PET/MRI for 
Biopsy Guidance in Patients with Suspected Prostate Cancer 
Protocol Number: 
IRB-48151  /  PROS0091 
Principal Investigator: 
Andrei Iagaru, MD 
 
Inclusion Criteria  
Yes must be checked to be eligible 
Yes 
No 
Supporting 
Documentation 
1. ≥ 18 years-old 
☐ 
☐ 
 
2. Suspected prostate cancer 
☐ 
☐ 
 
3. Planned prostate biopsy 
☐ 
☐ 
 
4. Able to provide written consent 
☐ 
☐ 
 
5. Karnofsky performance status of ≥ 50 (or ECOG/WHO 
equivalent) 
☐ 
☐ 
 
 
Exclusion Criteria  
No must be checked to be eligible 
Yes 
No 
Supporting 
Documentation 
1. 
Patients not capable of getting PET study due to weight, 
claustrophobia, or inability to lay still for the duration of 
the exam 
☐ 
☐ 
 
2. 
Metallic implants (contraindicated for MRI) 
☐ 
☐ 
 
*All subject files must include supporting documentation to confirm subject eligibility.  The method of 
confirmation can include, but is not limited to, laboratory test results, radiology test results, subject 
self-report, and medical record review.   
 
Statement of Eligibility 
By signing this form of this trial I verify that this subject is [☐eligible / ☐ ineligible] for participation in the 
study.  This study is approved by the Stanford Cancer Institute Scientific Review Committee, the Stanford 
IRB, and has finalized financial and contractual agreements as required by Stanford School of Medicine’s 
Research Management Group.   
Treating Physician Signature: 
Date: 
Printed Name: 
 
 
Study Coordinator Signature: 
Date: 
Printed Name: 
 
 
Secondary Reviewer Signature: 
Date: 
Printed Name: