Clinical trial NCT02918357
Conditions: Prostate Cancer
Sponsor: University of California, San Francisco
Start date: 2016-09-15; Completion date: 2017-09-21
Enrollment: 385 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.

Detailed description:
Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the biochemical recurrence population, the primary objective is to determine the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy.

Arms: arm 1: PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
Interventions: intervention 1: Ga-68 labeled PSMA-11 PET
Intervention descriptions: intervention 1: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

Protocol documents:
Prot_SAP_000.pdf: 
Gallium-68 PSMA-11 PET in patients with biochemical 
recurrence
Protocol Number:  CC #165510
Study Drug:  Gallium-68 PSMA-11
Version Number:  Version 1.1
Version Date:  08/21/2016
IND Number:  127621
Principal Investigator (Sponsor-Investigator)
Thomas Hope, MD
Co-Investigators
Dr. Rahul Aggarwal, MD
Dr. Peter Carroll, MD
Dr. Albert Chang, MD
Dr. Matthew Cooperberg, MD
Dr. Michael Evans, PhD
Dr. Felix Feng, MD
Dr. Larry Fong, MD
Dr. Terence Friedlander, MD
Dr. Kirsten Greene, MD
Dr. Won Kim, MD
Dr. John Kurhanewicz, PhD
Dr. Amy Lin, MD
Dr. Hao Nguyen, MD
Dr. Mack Roach, MD
Dr. Chuck Ryan, MD
Dr. Jim Slater, PhD
Dr. Eric Small, MD
Dr. Li Zhang, PhD (Statistician)
Clinical Research Coordinator
Proprietary and Confidential
The information in this document is considered privileged and confidential, and may not be disclosed to others except 
to the extent necessary to obtain Institutional Review Board approval and informed consent, or as required by 
Federal and State laws.  Persons to whom this information is disclosed should be informed that this information is 
privileged and confidential and that it should not be further disclosed.
NCT#02918357


Protocol Signature Page
Protocol No.:     
Version Date: 
1.
I agree to follow this protocol version as approved by the UCSF Protocol Review Committee
(PRC), Committee on Human Research (CHR), and Data Safety Monitoring Committee
(DSMC).
2.
I will conduct the study in accordance with applicable CHR requirements, Federal
regulations, and state and local laws to maintain the protection of the rights and welfare of
study participants.
3.
I certify that I, and the study staff, have received the requisite training to conduct this
research protocol.
4.
I have read and understand the information in the Investigators’ Brochure (or Manufacturer’s
Brochure) regarding the risks and potential benefits. I agree to conduct the protocol in
accordance with Good Clinical Practices (ICH-GCP), the applicable ethical principles, the
Statement of Investigator (Form FDA 1572), and with local regulatory requirements. In
accordance with the FDA Modernization Act, I will ensure the registration of the trial on the
www.clinicaltrials.gov website.
5.
I agree to maintain adequate and accurate records in accordance with CHR policies,
Federal, state and local laws and regulations.
UCSF Principal Investigator / Study Chair
           Thomas A. Hope
Printed Name
Signature
Date


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Phase II – 68Ga-PSMA-11
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Abstract
Title
Gallium-68 PSMA-11 PET in patients with biochemical recurrence
Patient 
population

Rising PSA after definitive therapy with prostatectomy or radiation therapy
(external beam or brachytherapy):
o
Post radical prostatectomy (RP) – AUA recommendation

PSA greater than 0.2 ng/mL measured more than 6 weeks after RP
and,

Confirmatory persistent PSA greater than 0.2 ng/mL
o
Post-radiation therapy – ASTRO-Phoenix consensus definition

Nadir + greater than or equal to 2 ng/mL rise in PSA
Rationale for 
Study
Gallium-68 HBED-CC PSMA has been shown to have a higher sensitivity for 
the detection of metastatic prostate cancer compared to choline based 
imaging.
Primary 
Objective

Sensitivity and positive predictive value (PPV) on a per-patient and per-
region-basis of 68Ga-PSMA-11 PET for detection of tumor location
confirmed by histopathology/biopsy.
Secondary 
Objectives

Sensitivity and PPV on a per-patient and per-region-basis of 68Ga-PSMA-
11 PET for detection of tumor location confirmed by histopathology/biopsy
and conventional imaging follow-up.

Sensitivity, specificity, and negative predictive value (NPV) on a per-
patient basis of 68Ga-PSMA-11 PET for detection of tumor location
confirmed by histopathology/biopsy and conventional imaging follow-up.

Detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by
PSA value (0.2 - <0.5, 0.5 - <1.0, 1.0 - <2.0, 2.0 - <5.0, 5.0).

Impact of 68Ga-PSMA-11 PET on clinical management in BCR patients.

Inter-reader reproducibility.

Safety.
Study Design
This is a phase 1/2 multi-center open label study. 
Number of 
patients
125 patients per year, for three years, giving a total of 375 patients at UCSF.  
Total population of patients will be 1,500 patients across all institutions.
Duration of 
Therapy
The study will involve a single imaging study.


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Duration of 
Follow up
The patients will be followed-up by phone one day after the study completion.
Duration of 
study
The study will reach completion three years from the time the study opens to 
accrual.
Study Drugs
Gallium-68 labeled PSMA-11 (PSMA-HBED-CC)
Safety 
Assessments
Patient vital signs will be taken immediately before and after the 
administration of the radiopharmaceutical.  The patients will also be asked to 
report adverse events.


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List of Abbreviations
AE
adverse event
CHR
Committee on Human Research (UCSF IRB)
CRC
Clinical Research Coordinator
CRF
case report form
CT
computerized tomography
CTCEA
Common Terminology Criteria for Adverse Events
DSMC
Data and Safety Monitoring Committee
DSMP
Data and Safety Monitoring Plan
ECOG
Eastern Cooperative Oncology Group
FDA
Food and Drug Administration
Ga-68
Gallium 68
HDFCCC
Helen Diller Family Comprehensive Cancer Center
ICH
International Conference on Harmonization
IND
investigational new drug application
IRB
Institutional Review Board
IV
intravenous
MRI
magnetic resonance imaging
NCI
National Cancer Institute
PET
PK
Positron Emission Tomography
pharmacokinetics
PRC
PSA
PSMA
Protocol Review Committee (UCSF)
Prostate specific antigen
Prostate specific membrane antigen
SD
standard deviation


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Table of Contents
Protocol Signature Page ...............................................................................................................0
Abstract
1
List of Abbreviations ......................................................................................................................3
Table of Contents ..........................................................................................................................4
1
Introduction6
1.1
Overview .........................................................................................................................6
1.2
Background......................................................................................................................6
1.3
Patient Population............................................................................................................7
2
Objectives of the Study............................................................................................................7
2.1
Primary ............................................................................................................................7
2.2
Secondary ........................................................................................................................7
2.3
Endpoints.........................................................................................................................8
2.3.1
Primary Endpoints ..............................................................................................8
2.3.2
Secondary endpoints ...........................................................................................8
3
Study Design ...........................................................................................................................8
3.1
Characteristics .................................................................................................................8
3.2
Number of Subjects .........................................................................................................8
3.3
Eligibility Criteria............................................................................................................8
3.3.1
Inclusion Criteria ................................................................................................8
3.3.2
Exclusion Criteria ...............................................................................................9
3.4
Duration of Follow Up ....................................................................................................9
3.5
Study Timeline ................................................................................................................9
3.5.1
Primary Completion............................................................................................9
3.5.2
Study Completion ...............................................................................................9
4
Study Drugs.............................................................................................................................9
4.1
Description, Supply and Storage of Investigational Drugs .............................................9
4.1.1
Investigational Drug #1.......................................................................................9
5
Treatment Plan......................................................................................................................10
5.1
Dosage and Administration ...........................................................................................10
5.1.1
Other Modality(ies) or Procedures....................................................................10
5.2
Monitoring and Toxicity Management..........................................................................10
6
Study Procedures and Observations.....................................................................................11
6.1
Schedule of Procedures and Observations ....................................................................11
6.1.2
Treatment Period...............................................................................................12
6.1.3
Post-treatment Follow Up Visits.......................................................................12
6.2
Prohibited Medications..................................................................................................13
7
Reporting and Documentation of Results..............................................................................13
7.1
Evaluation of Efficacy (or Activity)..............................................................................13
7.2
Evaluation of Safety ......................................................................................................13
7.3
Definitions of Adverse Events.......................................................................................13
7.3.1
Adverse Event...................................................................................................13
7.3.2
Adverse reaction ...............................................................................................13
7.4
Recording of an Adverse Event.....................................................................................14
7.5
Follow-up of Adverse Events........................................................................................15


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Table of Contents
7.6
Expedited Reporting......................................................................................................15
8
Statistical Considerations and Evaluation of Results ............................................................16
8.1
Study Endpoints.............................................................................................................16
8.1.1
Randomization ..................................................................................................16
8.2
Determination of Sample Size and Accrual Rate ..........................................................16
8.2.1
Sample Size and Power Estimate......................................................................16
8.2.2
Accrual estimates..............................................................................................17
8.3
Analyses Plans...............................................................................................................17
8.3.1
Analysis Population ..........................................................................................17
8.3.2
Analysis of Primary Endpoints .........................................................................17
8.3.3
Analysis of Secondary Endpoints .....................................................................21
9
Study Management ...............................................................................................................21
9.1
Pre-study Documentation ..............................................................................................21
9.2
Institutional Review Board Approval............................................................................21
9.3
Informed Consent ..........................................................................................................22
9.4
Changes in the Protocol.................................................................................................22
10
Protection of Human Subjects.............................................................................................22
10.1
Protection of Privacy ...................................................................................................22
References
23
Appendices
25
Appendix 1
Performance Status Criteria...............................................................................25
Appendix 2 (flow chart)................................................................................................................26
Appendix 3 (pre- and post-surveys) ............................................................................................27
List of Tables
Table 1 .............................................................................................................................................5
Table 2 .............................................................................................................................................6
Table 3.1
Schedule of Study Procedures and Assessments........................................................11


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1
Introduction
1.1
Overview
Imaging and staging of prostate cancer is critical for surgical and treatment planning.  We aim to 
image patients with suspected metastatic prostate cancer using Gallium-68 labeled HBED-CC 
PSMA (more commonly called 68Ga-PSMA-11) in order to demonstrate its utility.   We plan to 
utilize this data to obtain further approvals of the 68Ga-PSMA-11 compound, so that this agent 
will become available for clinical imaging in prostate cancer patients.  
This compound has been shown to be superior to choline based PET agents for the staging of 
prostate cancer, both Carbon-11 and Fluorine-18 compounds.  But this compound was not 
patented and therefore no company or private entity will make the investment required to bring 
HBED-CC PSMA to market.  In the vacuum of availability, academic groups must take the lead 
in order to collect the necessary data for future FDA approval.  This protocol was developed in 
collaboration with the Clinical Trials Network of the Society of Nuclear Medicine and Molecular 
Imaging.  The inclusion criteria and study endpoints have been aligned so that inter-institutional 
sharing of data can be performed in order to pool data for final NDA submission..
1.2
Background
Prostate cancer is the most commonly diagnosed cancer and second leading cause of cancer 
death in American men (1).   Existing conventional imaging (CT, MRI and bone scans) has a 
low sensitivity in detecting local recurrence or metastatic disease (2).  The one exception being 
NaF PET/CT for the detection of osseous metastasis.  Due to this limitation, numerous 
approaches to stage patients have been evaluated.
Choline imaging has been frequently used, as prostate cancer exhibits increase choline uptake 
that has been associated with the presence of choline kinase (3).  Choline uptake is increased 
in comparison to FDG in both androgen dependent and independent prostate cancer patients 
(4).  Choline has also been shown to be sensitive for the detection of recurrent tumor in patients 
with PSA (prostate specific antigen) values of less than 1.0 ng/ml (5).  There are two forms of 
choline that are used in imaging prostate cancer, C-11 and F-18 choline.  C-11 choline has a 
short half-life of 20 minutes, which limits its detection for metastatic disease but results in 
improved local detection due to decreased urinary activity at the time of imaging.  F-18 choline 
has significant urinary excretion that limits evaluation of the prostate but, but has been shown to 
have better detection rates for distant metastatic disease (6).  C-11 choline has limited 
sensitivity for osseous metastasis, possibly due to the decreased uptake time (7).  Additionally, 
the sensitivity of C-11 choline is limited in patients with PSA values < 1.0 ng/ml (8-10).  Although 
choline PET may be limited in sensitivity, it clearly delineates more lesions than cross section 
imaging or bone scan in patients with known disease (11).   In 2012, the Mayo Clinic obtained 
NDA (new drug application) approval from the FDA for the use of C-11 choline.  
A separate approach is to image the prostate specific membrane antigen (PSMA).  PSMA is 
expressed on the majority of prostate cancer cells, and so would be an ideal cell membrane 
protein to image.  The initial imaging approach to PSMA imaging target the intracellular domain 
using Indium-111-capromab (Prostascint), a murine monoclonal antibody (12,13).  Although 
there was early promise for the detection of nodal metastasis (14), the agent was never able to 
adequately visualize osseous metastasis (15).  Although combination with SPECT/CT does 
improve lesion detection (16).  One main limitation to In-111-capromab is that it takes a 
prolonged time to localize to the target tissue, which likely relates to both the size of the 
monoclonal antibody and the fact that agent targets the intracellular domain of the PSMA 
protein. Additionally, Prostascint also recognizes an intracellular epitope so the antibody must 
cross the membrane to be effective. This likely only occurs in permeable dead or dying tumor 
cells. 


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Because of the limitations of In-111 capromab, there has been continued effort to develop 
agents that target the extracellular domain of the PSMA protein. The Ga-68 labeled HBED-CC 
PSMA compound has become of particular interest because in the last year there have been 
two important articles. The first demonstrates that HBED-CC PSMA has a higher sensitivity for 
the detection of disease than F-18 choline in a head-to-head intra-patient comparison that 
included 37 patients (17).  The second paper looked at the sensitivity of HBED-C PSMA in the 
detection of metastatic lesions in patients with recurrent prostate cancer (18).  Their results 
demonstrated a detection rate of 50% for patients with a PSA less than 1 ng/ml, and detection 
rate above 85% for patients with a PSA greater than 2 ng/ml.  These detection rates are 
significantly higher than that reported by groups using choline (5).
Because of the improved resolution and image quality with PET, ability to quantitate uptake, 
increased sensitivity compared to choline, we intend to evaluate the utility of Ga-68 HBED-CC 
PSMA for the imaging of prostate cancer. We expect that the data from this study will support 
applications for clinical approval of this imaging agent, leading to wider availability within the 
United States. 
Of note, although this project does not include biopsy correlation, a separate small trial is being 
initiated at the San Francisco VA Medical Center in pre-prostatectomy patients to determine the 
sensitivity and specificity of nodal uptake seen on Ga-68 HBED-CC PSMA imaging.  This will 
help to demonstrate the specificity of imaging uptake on the PET imaging.
1.3
Patient Population
Patients with biochemical recurrence after prostatectomy or radiation therapy:
(a) Post radical prostatectomy (RP) – AUA recommendation

PSA greater than 0.2 ng/mL measured more than 6–13 weeks after RP
and,

Confirmatory persistent PSA greater than 0.2 ng/mL 
(b) Post-radiation therapy –ASTRO-Phoenix consensus definition

Nadir + greater than or equal to 2 ng/mL rise in PSA
2
Objectives of the Study
2.1
Primary

Sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis
(Table 1) of 68Ga-PSMA-11 PET for detection of tumor location confirmed by
histopathology/biopsy.
2.2
Secondary

Sensitivity and PPV on a per-patient and per-region-basis (Table 1) of 68Ga-PSMA-11
PET for detection of tumor location confirmed by histopathology/biopsy and conventional
imaging follow-up.
Region
Description
1
Prostate Bed
2
Pelvis outside of prostate bed including lymph nodes
3
Extrapelvic soft tissue, lymph nodes and organ metastases (non-bone)
4
Bone metastases


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
Sensitivity, specificity, and negative predictive value (NPV) on a per-patient basis of
68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy
and conventional imaging follow-up.

Detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA value (0.2
- <0.5, 0.5 - <1.0, 1.0 - <2.0, 2.0 - <5.0, 5.0).

Impact of 68Ga-PSMA-11 PET on clinical management in BCR patients.

Inter-reader reproducibility

Safety.
2.3
Endpoints
2.3.1 Primary Endpoints

Per patient and per region 68Ga-PSMA-11 positivity.

Biopsy correlation.
2.3.2 Secondary endpoints

Per patient and per region detection sensitivity using a combined histology and
conventional imaging correlate

Sensitivity, specificity and negative predictive value on a per-patient basis.

Change in management: survey based results

Inter-reader reproducibility

Safety: blood pressure, heart rate, self reported adverse events
3
Study Design
3.1
Characteristics
This is a prospective, Phase 1/2, multi-center, open-label study in patients with prostate cancer. 
Eligible participants will undergo baseline assessments at enrollment. Study participants will 
receive a one-time administration of Ga-68 PSMA-11 and undergo a PET/CT or PET/MRI 
imaging study. 
3.2
Number of Subjects
It is anticipated that 125 patients per year over three years will be enrolled in this study, for a 
total of 375 at UCSF.  In total we aim to enroll 1,500 patients across all sites.
3.3
Eligibility Criteria
Patients must have baseline evaluations performed prior to the administration of the 
radiopharmaceutical and must meet all inclusion and exclusion criteria.  In addition, the patient 
must be thoroughly informed about all aspects of the study, including the study visit schedule 
and required evaluations and all regulatory requirements for informed consent.  The written 
informed consent must be obtained from the patient prior to enrollment.  The following criteria 
apply to all patients enrolled onto the study unless otherwise specified.
3.3.1 Inclusion Criteria
1.
Histopathological proven prostate adenocarcinoma.
2.
Rising PSA after definitive therapy with prostatectomy or radiation therapy (external
beam or brachytherapy).


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a.
Post radical prostatectomy (RP) – AUA recommendation
i.
PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,
ii.
Confirmatory persistent PSA greater than 0.2 ng/mL
b.
Post-radiation therapy –ASTRO-Phoenix consensus definition
i.
Nadir + greater than or equal to 2 ng/mL rise in PSA
3.
Karnofsky performance status of 50 (or ECOG/WHO equivalent).
4.
Age > 18.
5.
Ability to understand a written informed consent document, and the willingness to sign it.
3.3.2 Exclusion Criteria
1.
Investigational therapy for prostate cancer.
2.
Unable to lie flat, still or tolerate a PET scan.
3.
Prior history of any other malignancy within the last 2 years, other than skin basal cell or
cutaneous superficial squamous cell carcinoma that has not metastasized and
superficial bladder cancer.
4.
Contraindication to furosemide administration including prior allergy or adverse reaction
to furosemide or sulfa drugs.  (Note: This exclusion criteria can be removed if
Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter
correction is available for the used PET device).
3.4
Duration of Follow Up
Patients will be followed for one day after the administration of the radiopharmaceutical.
3.5
Study Timeline
3.5.1 Primary Completion
The study will reach primary completion 36 months from the time the study opens to accrual.
3.5.2 Study Completion
The study will reach study completion 48 months from the time the study opens to accrual.
4
Study Drugs
4.1
Description, Supply and Storage of Investigational Drugs
4.1.1 Investigational Drug #1
Ga-68 labeled PSMA-11 (or PSMA-HBED-CC) is a radiopharmaceutical that will be produced 
under cGMP by a research pharmacists certified and highly experienced in the Department of 
Radiology and Biomedical Engineering, 
. The radiopharmaceutical will be made 
at the China Basin Imaging Center.  Imaging will occur at both the China Basin Imaging Center 
and the San Francisco VA Medical Center.  


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5
Treatment Plan
5.1
Dosage and Administration
The imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) will be administered on an outpatient 
basis.  It will be administered a single time intravenously prior to the PET imaging.  The one-
time nominal injected dose will be 3 to 7 mCi of 68Ga-PSMA-11.
5.1.1 Other Modality(ies) or Procedures
5.1.1.1 Change in management surveys
Referring clinicians will be required to fill out a pre-imaging survey within 30 days of imaging.  
Please see Appendix 3.  Additionally within 30 days of the completion of imaging, the referring 
physician will be requested to fill out a post-imaging survey, and finally six months after imaging, 
a third survey will be filled out.
5.1.1.2 PET imaging
a)
68Ga-PSMA-11 PET preparation and injection:
The injected dose will be 111-259 MBq (3-7 mCi) of 68Ga-PSMA-11 PET.  A dose of 20
mg of Furosemide (Lasix) is recommended to be injected together with, shortly before or
after administration of the radiotracer in order to minimize PET scatter artifacts from
excreted radiotracer accumulation in the kidney and urinary bladder that can occur with
the gallium-68 radionuclide.  Oral hydration and voiding is recommended immediately
before start of the scan.  Furosemide should not be administered in patients with medical
contraindications to Furosemide administration including allergies and adverse reactions
including sulfa allergies.  (Note: Application of Furosemide can be omitted as part of the
PET imaging protocol if a second-generation scatter correction algorithm is available for
the PET scanner used in this protocol).    PET imaging will begin 50-100 minutes after
injection.  Scan time per bed position will be determined based on each sites PET
scanner capabilities.
b) Patient preparation: no fasting is required.
c)
PET protocol: Scan coverage will extend from mid thigh to the base of the skull, starting
from the mid-thighs to prevent urinary bladder radiotracer accumulation at the start of
PET imaging.  Bed position scan time will be dependent on each sites scanner
capabilities.  At a minimum, 3 minutes per bed position will be used.  In certain
circumstances, coverage may be extended to the toes.  Contrast may be administered if
requested by the referring clinician and is decided site dependent.
d) Patient monitoring: Vital signs will be assessed immediately before and after injection of
68Ga-PSMA-11 (HR and supine BP).  Patients will be monitored for adverse events
during injection and for two hours after radiotracer administration.   Additionally, patient’s
vitals (HR and supine BP) will be checked at the completion of the imaging study prior to
leaving the imaging center.
e) Patient follow-up: Patients will be contacted by phone one to three days after 68Ga-
PSMA-11 PET to assess for the development of delayed adverse events.  Patients will
be seen in the clinic if there are any concerning study related adverse events requiring
further evaluation.


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5.2
Monitoring and Toxicity Management
Each patient receiving Ga-68 PSMA-11 will be evaluable for safety.  The safety parameters 
include physical findings and spontaneous reports of adverse events reported to the investigator 
by patients.
6
Study Procedures and Observations
6.1
Schedule of Procedures and Observations
Screening assessments must be performed within 30 days prior to the first dose of 
investigational product.  Any results falling outside of the reference ranges may be repeated at 
the discretion of the investigator.  Treatment or visit delays for public holidays or weather 
conditions do not constitute a protocol violation.
A written, signed, informed consent form (ICF) and a Health Insurance Portability and 
Accountability Act (HIPAA) authorization must be obtained before any study-specific 
assessments are initiated.  A copy of the signed ICF will be given to the subject and a copy will 
be filed in the medical record.  The original will be kept on file with the study records.  
6.1.1.1 Screening Assessments 
The Screening procedures and assessments must be completed within 30 days of the day 1 
Visit. 

Laboratory values: all patients must have a recent PSA (within 30 days prior to study
enrollment) consistent with BCR
Table 1.1
Schedule of Study Procedures and Assessments
Period/
Procedure
Screening
Imaging day 1
One day post 
imaging
Follow-up surveys
Study Day/Visit Day
-30 to 1
1
2
2 to 30 days and 
six months
Informed consent
X
Laboratory values, history 
from medical record
X
Pre-survey
X
Performance status
X
Blood Pressure, HR
X
X
Imaging Procedure
68Ga-PSMA-11
X
PET/CT or PET/MRI 
X
Follow-up
Adverse event reporting
X
Post-survey
XX


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
Pathology: all patients must have histopathology/biopsy of the prostate with a
documented Gleason score

Performance status: all patients must have their Karnofsky performance status (or
ECOG/WHO equivalent) evaluated (Appendix A).
6.1.2 Treatment Period
6.1.2.1 Study Procedures, Imaging Day 1

Vital signs

Evaluation of adverse events
6.1.3 Post-treatment Follow Up Visits
Patients will be followed for two weeks after enrollment, by phone.  The following procedure will 
be performed at two weeks:

Evaluation of adverse events


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6.2
Prohibited Medications
There are no prohibited medications.
7
Reporting and Documentation of Results
7.1
Evaluation of Efficacy (or Activity)
7.1.1.1 Definitions
Evaluable for toxicity
All patients will be evaluable for toxicity from the time of 68Ga-PSMA-11.
7.2
Evaluation of Safety
Analyses will be performed for all patients receiving 68Ga-PSMA-11.  The study will use the 
CTCAE v4.0 for reporting of adverse events.
7.3
Definitions of Adverse Events
7.3.1 Adverse Event
An adverse event (also known as an adverse experience) is defined as any untoward medical 
occurrence associated with the use of a drug in humans, whether or not considered drug 
related.  More specifically, an adverse event (can be any unfavorable and unintended sign (e.g., 
an abnormal laboratory finding), symptom, or disease temporally associated with the use of a 
drug, without any judgment about causality.  An adverse event can arise from any use of the 
drug (e.g., off-label use, use in combination with another drug) and from any route of 
administration, formulation, or dose, including an overdose. 
7.3.2 Adverse reaction
An adverse reaction is defined as any adverse event caused by the use of a drug.  Adverse 
reactions are a subset of all suspected adverse reactions for which there is reason to conclude 
that the drug caused the event.
7.3.2.1 Suspected 
A suspected adverse reaction is defined as any adverse event for which there is a reasonable 
possibility that the drug caused the adverse event. For the purposes of IND safety reporting, 
“reasonable possibility” indicates that there is evidence to suggest a causal relationship 
between the drug and the adverse event.  A suspected adverse reaction implies a lesser degree 
of certainty about causality than an adverse reaction.
7.3.2.2 Unexpected 
An adverse event or suspected adverse reaction is considered unexpected if it is not listed in 
the investigator brochure or package insert(s), or is not listed at the specificity or severity that 
has been observed, or, if an investigator brochure is not required or available, is not consistent 
with the risk information described in the general investigational plan or elsewhere in the current 
application. 
“Unexpected,” as used in this definition, also refers to adverse events or suspected adverse 
reactions that are mentioned in the investigator brochure as occurring with a class of drugs or 


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as anticipated from the pharmacological properties of the drug, but are not specifically 
mentioned as occurring with the particular drug under investigation.
Adverse events that would be anticipated to occur as part of the disease process are 
considered unexpected for the purposes of reporting because they would not be listed in the 
investigator brochure.  For example, a certain number of non-acute deaths in a cancer trial 
would be anticipated as an outcome of the underlying disease, but such deaths would generally 
not be listed as a suspected adverse reaction in the investigator brochure.
7.3.2.3 Serious
An adverse event or suspected adverse reaction is considered serious if, in the view of either 
the investigator or sponsor, it results in any of the following outcomes: 

Death

Life-threatening adverse event

Inpatient hospitalization or prolongation of existing hospitalization

A persistent or significant incapacity or substantial disruption of the ability to conduct
normal life function

Congenital anomaly/birth defect
Important medical events that may not result in death, are life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgment, 
they may jeopardize the patient or subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in this definition.  Examples of such medical events include 
allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood 
dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of 
drug dependency or drug abuse.
7.3.2.4 Life-threatening
An adverse event or suspected adverse reaction is considered life-threatening if, in the view of 
either the investigator or sponsor, its occurrence places the patient or subject at immediate risk 
of death. It does not include an adverse event or suspected adverse reaction that, had it 
occurred in a more severe form, might have caused death. 
7.4
Recording of an Adverse Event
All grade 3 and above adverse events will be recorded using the NCI CTCAE v4.0.   The 
Investigator will assign attribution of the possible association of the event with use of the 
investigational drug. 
Relationship 
Attribution 
Description 
Unrelated
The AE is clearly NOT related to the 
intervention 
Unrelated to investigational 
drug/intervention
Unlikely
The AE is doubtfully related to the 
intervention 
Possible
The AE may be related to the intervention 
Probable
The AE is likely related to the intervention 
Related to investigational 
drug/intervention
Definite
The AE is clearly related to the intervention 


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Signs or symptoms reported as adverse events will be graded and recorded by the Investigator 
according to the CTCAE.  When specific adverse events are not listed in the CTCAE they will be 
graded by the Investigator as none, mild, moderate or severe according to the following grades 
and definitions:
Grade 0
No AE (or within normal limits)
Grade 1
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated
Grade 2
Moderate; minimal, local, or noninvasive intervention (e.g., packing, cautery) 
indicated; limiting age-appropriate instrumental activities of daily living (ADL)
Grade 3:
Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-
care ADL
Grade 4:
Life-threatening consequences; urgent intervention indicated
Grade 5:
Death related to AE
7.5
Follow-up of Adverse Events
All adverse events will be followed with appropriate medical management until resolved.  
Patients removed from study for unacceptable adverse events will be followed until resolution or 
stabilization of the adverse event.  For selected adverse events for which administration of the 
investigational drug was stopped, a re-challenge of the subject with the investigational drug may 
be conducted if considered both safe and ethical by the Investigator.
7.6
Expedited Reporting 
Reporting to the Data and Safety Monitoring Committee
If a death occurs during the treatment phase of the study or within 30 days after the last 
administration of the study drug(s) and it is determined to be related either to the study drug(s) 
or to a study procedure, the Investigator or his/her designee must notify the DSMC Chair (or 
qualified alternate) within 1 business day of knowledge of the event.  The contact may be by 
phone or e-mail.
Reporting to UCSF Committee on Human Research (Institutional Review Board)
The Principal Investigator must report events meeting the UCSF CHR definition of 
“Unanticipated Problem” (UP) and the San Francisco VA Medical Center within 5 business days 
of his/her awareness of the event. 
Expedited Reporting to the Food and Drug Administration
If the study is being conducted under an IND, the Sponsor-Investigator is responsible for 
determining whether or not the suspected adverse reaction meets the criteria for expedited 
reporting in accordance with Federal Regulations (21 CFR §312.32). 
The Investigator must report in an IND safety report any suspected adverse reaction that is both 
serious and unexpected.  The Sponsor-Investigator needs to ensure that the event meets all 
three definitions: 

Suspected adverse reaction (as defined in 6.1.30)

Unexpected (as defined in 0)

Serious (as defined in 6.1.5)


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If the adverse event does not meet all three of the definitions, it should not be submitted as an 
expedited IND safety report.
The timeline for submitting an IND safety report to FDA is no later than 15 calendar days after 
the Investigator determines that the suspected adverse reaction qualifies for reporting (21 CFR 
312.32(c)(1)). 
Any unexpected fatal or life-threatening suspected adverse reaction will be reported to FDA no 
later than 7 calendar days after the Investigator’s initial receipt of the information (21 CFR 
312.32(c)(2)). 
Any relevant additional information that pertains to a previously submitted IND safety report will 
be submitted to FDA as a Follow-up IND Safety Report without delay, as soon as the 
information is available (21 CFR 312.32(d)(2)). 
8
Statistical Considerations and Evaluation of Results
8.1
Study Endpoints

Per patient and per region 68Ga-PSMA-11 positivity.

Biopsy correlation.
8.1.1 Randomization
There will be no randomization performed.  There will be no blinding performed.
8.2
Determination of Sample Size and Accrual Rate
8.2.1 Sample Size and Power Estimate
The primary endpoint is to evaluate the positive predictive value (PPV) on a (1) per-patient and 
(2) per-region-basis (prostate bed, pelvis, extrapelvic soft tissue, and bone metastases) of 68Ga-
PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy. Based on the
results of previous studies, the following distribution of disease across the four regions are
anticipated (19-21):
a) Prostate bed: 30%
b) Pelvis: 15%
c)
Extrapelvic soft tissue: 20%
d) Bone metastases: 35%
It is anticipated that the PPV for the four regions and for all regions combined using 
conventional imaging ranges from 30-60%. An overall PPV for 68Ga-PSMA-11 PET of at most 
50% will be considered as unacceptably low. Hence, the null hypothesis that the PPV is at most 
50% will be tested against the alternative hypothesis that the PPV is greater than 50%. It is 
hypothesized that 68Ga-PSMA-11 PET imaging on the per-region and per-patient basis will 
substantially increase the PPV for the four regions to at least 70%. A sample size of 75 true 
positives is required for rejecting the null hypothesis that the PPV is at most 50% with 90% 
power at the one-sided 0.01 (=0.05/5 – a Bonferroni adjustment for evaluating the PPV for the 
four regions and for all regions combined) significance level, assuming an average regions 
specific prevalence of 20%.  It is expected that approximately 25% of the accrued patients will 
undergo a biopsy.  Hence, the proposed total number of patients requiring a biopsy is 375 in 


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order to power the analysis at a per region level. Assuming a prevalence rate of 20% for 
disease in each individual region, a total sample size of 1,500 patients is required.  The 
following table shows the attainable power levels for detecting an increase in the PPV from 50% 
to 70% at the one-sided 0.01 significance level for the four disease regions and for all regions 
combined with the proposed sample size of 1500 patients:
Table: Attainable power levels for detecting an increase in PPV from 50% to 70% with sample 
size of 1,500 patients (375 biopsies)
Prevalence
Number of Biopsies with 
True Positives
Power
Prostate bed
30%
113
98%
Pelvis
15%
56
78%
Extrapelvic soft tissue
20%
75
90%
Bone metastases
35%
131
>99%
All regions combined
100%
375
>99%
In summary, the proposed target accrual of 1,500 patients (375 with biopsies) will provide 
adequate power for detecting the anticipated improvement in the PPV for both the per-patient 
and per-region based 68Ga-PSMA-11 PET imaging when compared to conventional imaging.  
However, a sample size of 107 patients with biopsies in total is sufficient for detecting the 
anticipated improvement in PPV when evaluating per-patient based positive predictive value.  
8.2.2 Accrual estimates
We estimate that roughly 125 patients with prostate cancer will be enrolled in this trial per year.  
Over a four-year period this will result in up to 375 patients being enrolled in the study.
8.3
Analyses Plans
8.3.1 Analysis Population
Patients with histopathology correlates will be analyzed for the Primary Aim.  All remaining 
patients will be analyzed for the secondary endpoints.
8.3.2 Analysis of Primary Endpoints
PPVs on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor 
location confirmed by histopathology/biopsy will be calculated and reported along with the 
corresponding two-sided 95% confidence intervals. The confidence intervals will be constructed 
using the Wilson score method.
a) Imaging interpretation 68Ga-PSMA-11 PET:
PET images will initially be interpreted by a board certified nuclear medicine physician or
a board certified radiologist experienced in reading PET at the time of the imaging study
at the institution that the study is being performed. These interpretations will not be used
for final evaluation.   For the data sets included in the analysis for the Primary Endpoint,
imaging data will be anonymized and collected at a central site. PET data will be
interpreted by three different readers in a random order at separate reading sessions.
68Ga-PSMA PET/CT reading training set and guides will be provided and completion of
this training will be required for all central review readers.


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Visual interpretation: 
Regions of suspected disease will be graded on a two-point scale by each reader 
(0=Negative or 1= Positive). A region will be judged as positive if at least one lesion in 
this region is visually positive.
i)
Lymph nodes will be considered positive if the 68Ga-PSMA-11 uptake is focal and
greater than blood pool (adjacent or mediastinal blood pool). Pelvic lymph nodes
will be subclassified according to their localization as follows: R/L obturator, R/L
external iliac, R/L internal iliac and other (total of 7 subgroups).
ii)
Visceral lesions will be considered positive if the 68Ga-PSMA-11 uptake is focal
and greater than physiologic background activity of the involvement organ or
anatomic site.
iii) Bone lesions will be considered positive if the 68Ga-PSMA-11 uptake is focal and
greater than physiologic bone marrow.
iv) Prostate bed and prostate lesions will be considered positive if the 68Ga-PSMA-
11 uptake is focal and greater than physiologic background activity of the
involvement organ or anatomic site.
b) Follow-up Imaging:
All patients will be followed up 3-12 months with conventional imaging (dedicated CT,
MRI and/or bone scan).  Interpretation of follow-up imaging will be performed by local
read. The follow-up conventional imaging should be the same modality/modalities as the
initial staging work-up to allow for reproducible and accurate comparisons.
68Ga-PSMA-11 PET positive findings will be validated as true or false positive as
outlined in more detail below. False negative 68Ga-PSMA-11 PET findings cannot be
determined as this would require biopsies of 68Ga-PSMA-11 negative but conventional or
functional non-68Ga-PSMA-11 PET positive imaging lesions. Inclusion of such patients
however would be violation of the inclusion criteria.
68Ga-PSMA-11 PET validation based on follow-up imaging:
i)
Lymph nodes will be assessed by change in size. 68Ga-PSMA-11 positive lymph
nodes will be considered:
(1) True positive:
- If on follow-up imaging within 3-12 months, lymph nodes seen on CT or MRI
decrease by more than 30% (for patients undergoing systemic treatment of
focal therapy at this site) or increase by more than 20% in short axis diameter
(with a minimum of 3 mm in change in size).
- If patients with solitary lymph node regions show a decrease of PSA by
greater than 50% after targeted treatment (i.e. external beam radiation) and
the lymph nodes do not change in size (less than 30% decrease or less than
20% increase in short axis diameter).
(2) False positive:


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- If on follow-up imaging within 3-12 months, sites of initial68Ga-PSMA-11
positive lymph node lesions seen on CT or MRI decrease by more than 30%
without systemic therapy or focal therapy at this site.
- If 68Ga-PSMA-11 positive lymph node lesions do not meet the criteria for
above false positive or true positive findings.
ii)
Visceral lesions (non-lymph node soft tissue or organ) will be assessed by
change in size. 68Ga-PSMA-11 positive visceral lesions will be considered:
(1) True positive:
- If on follow-up imaging within 3-12 months, visceral lesions seen on CT or
MRI decrease by 30% (for patients undergoing systemic treatment of focal
therapy at this site)or increase by 20% in largest diameter.
- If patients with solitary visceral metastasis show a decrease of PSA by
greater than 50% after targeted treatment (i.e. external beam radiation) and
lesions do not change in size (less than 30% decrease or 20% increase in
largest diameter).
(2) False positive:
- If on follow-up imaging within 3-12 months, sites of initial68Ga-PSMA-11
positive lymph node lesions seen on CT or MRI decrease by more than 30%
without systemic therapy or focal therapy at this site.
- If 68Ga-PSMA-11 positive lymph node lesions do not meet the criteria for
above false positive or true positive findings.
iii)
68Ga-PSMA-11 positive bone lesions will be considered:
(1) True positive:
- If there was a corresponding positive sclerotic lesion on the CT portion of
the 68Ga-PSMA-11 PET.
- If there is focal uptake seen on the baseline bone scan performed within
one month of 68Ga-PSMA-11 PET.
- If there is a lesion noted on the initial MRI performed within one month of
68Ga-PSMA-11 PET.
- If within 12 months follow-up CT demonstrates development of sclerosis.
- If within 12 months follow-up MRI demonstrates a new bone lesion.
- If within 12 months follow-up bone scan demonstrates new focal uptake.
(2) False positive:
- If 68Ga-PSMA-11 positive bone lesions do not meet the criteria for true
positive findings.
iv)
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(1) True positive:
- If on follow-up imaging within 12 months, lesions seen on CT or MRI
decrease by 30% (for patients undergoing systemic treatment of focal therapy
at this site) or increase by 20% in largest diameter..
- If patients with prostate bed lesions show a decrease of PSA by greater
than 50% after targeted treatment (i.e. external beam radiation) and lesions
do not change in size (less than 30% decrease or 20% increase in largest
diameter).
(2) False positive:
- If on follow-up imaging within 3-12 months, sites of initial68Ga-PSMA-11
positive lymph node lesions seen on CT or MRI decrease by more than 30%
without systemic therapy or focal therapy at this site.
- If 68Ga-PSMA-11 positive lymph node lesions do not meet the criteria for
above false positive or true positive findings.
c)
Histopathology/Biopsy:
i)
Localization of lesions for histopathology/biopsy will be a classified according to the
regions in table 1.
ii)
68Ga-PSMA-11 positive findings are aimed to be confirmed by histopathology/biopsy
if clinically feasible.
iii) Histopathological procedures and biopsies will be performed as clinically indicated
and as per institutional protocol.
(1) Positive HP/Biopsy: Confirmed sites of metastatic or tumor involvement by
histopathology/biopsy will be discussed with the responsible physician/surgeon.
(2) Negative Biopsy: Patients with suspected tumor recurrence on 68Ga-PSMA-11
PET with negative histopathology/biopsy will be handled as outlined below:
(a) Lymph nodes:

For patients undergoing nodal dissection: Patients will be rescanned with
dedicated CT or MRI to determine if the suspicious 68Ga-PSMA-11 
positive node was removed.  
1.
If 68Ga-PSMA-11 positive lymph node is still present, a repeat biopsy
can be pursued if clinically feasible and applicable, or follow-up using
imaging as described above will be performed.
2.
If the corresponding node was removed, then this will be considered a
False Positive.

For patients undergoing needle biopsy: Images of the procedure will be 
reviewed to determine if the correct node was biopsied.  
1.
If the correct node was biopsied, then a negative biopsy will be
considered a False Positive.


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2.
If the incorrect node was biopsied, then follow-up imaging as
described above will be performed.
(b) Bone lesions:  Given the high rate of false negative biopsies for osseous
metastases in patients with prostate cancer, patients with negative bone
biopsies of PSMA PET positive lesions will be further evaluated:

If pathology demonstrates an alternative diagnoses that is known to be
PSMA positive (eg Renal Cell Carcinoma metastases, Paget’s disease), 
then this will be considered a False Positive.

If pathology is indeterminate, then follow-up imaging as described above 
will be performed to determine if the lesion is a True Positive or False 
Positive.
(c) Additionally a repeat 68Ga-PSMA-11 can also be obtained, as allowable, in
addition to repeat conventional imaging (CT and/or MRI) in cases of negative
biopsy to determine if the biopsy was true negative or false negative.
(d) Although not routinely performed during standard practice,
immunohistochemical staining for PSMA of tumor specimens (primary and
lymph node metastases) may be performed, although not required.
8.3.3 Analysis of Secondary Endpoints
PPVs on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor 
location confirmed by histopathology/biopsy and conventional imaging follow-up will be 
calculated and reported along with the corresponding two-sided 95% confidence intervals. The 
paired McNemar’s test will be used to compare the PPVs of 68Ga-PSMA-11 PET imaging to the 
PPVs of conventional imaging.
Sensitivity, specificity, and NPVs on a per-patient basis of 68Ga-PSMA-11 PET for detection of 
tumor location confirmed by histopathology/biopsy will be summarized in tabular format. 
Furthermore, the positive and negative likelihood ratios (LR+ and LR-) will be calculated and 
reported. Ninety-five confidence intervals of sensitivity, specificity, and NPV will be calculated 
using the Wilson score method. The comparisons of sensitivity, specificity, and NPV on a per-
patient basis of  68Ga-PSMA-11 PET imaging will be compared to of sensitivity, specificity, and 
NPV on a per-patient basis of conventional imaging using a paired McNemar’s test.
Detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA value (0.2 - <0.5, 
0.5 - <1.0, 1.0 - <2.0, 2.0 - <5.0, 5.0) will be summarized in tabular format and compared 
between PSA strata using chi-square analysis. The impact of 68Ga-PSMA-11 PET on clinical 
management in BCR patients will be evaluated using descriptive statistics. 
9
Study Management
9.1
Pre-study Documentation
This study will be conducted in accordance with the ethical principles that have their origin in the 
Declaration of Helsinki as stated in 21 CFR §312.120(c)(4); consistent with GCP and all 
applicable regulatory requirements.
Before initiating this trial, the Investigator will have written and dated approval from the 
Institutional Review Board for the protocol, written informed consent form, subject recruitment 


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materials, and any other written information to be provided to subjects before any protocol 
related procedures are performed on any subjects.  
The clinical investigation will not begin until either FDA has determined that the study under the 
Investigational Drug Application (IND) is allowed to proceed or the Investigator has received a 
letter from FDA stating that the study is exempt from IND requirements.
9.2
Institutional Review Board Approval
The protocol, the proposed informed consent form, and all forms of participant information 
related to the study (e.g. advertisements used to recruit participants) will be reviewed and 
approved by the UCSF CHR (UCSF Institutional Review Board).  Prior to obtaining CHR 
approval, the protocol must be approved by the Helen Diller Family Comprehensive Cancer 
Center Site Committee and by the Protocol Review Committee (PRC).  The initial protocol and 
all protocol amendments must be approved by the IRB prior to implementation.  
9.3
Informed Consent
All participants must be provided a consent form describing the study with sufficient information 
for each participant to make an informed decision regarding their participation.  Participants 
must sign the CHR-approved informed consent form 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. 
9.4
Changes in the Protocol
Once the protocol has been approved by the UCSF CHR, any changes to the protocol must be 
documented in the form of an amendment.  The amendment must be signed by the Investigator 
and approved by PRC and the CHR prior to implementation.  
If it becomes necessary to alter the protocol to eliminate an immediate hazard to patients, an 
amendment may be implemented prior to CHR approval.  In this circumstance, however, the 
Investigator must then notify the CHR in writing within five (5) working days after 
implementation.  The Study Chair and the UCSF study team will be responsible for updating any 
participating sites.
10
Protection of Human Subjects
10.1
Protection of Privacy
Patients will be informed of the extent to which their confidential health information generated 
from this study may be used for research purposes. Following this discussion, they will be asked 
to sign the HIPAA form and informed consent documents. The original signed document will 
become part of the patient’s medical records, and each patient will receive a copy of the signed 
document. The use and disclosure of protected health information will be limited to the 
individuals described in the informed consent document.


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Imaging. 2015;42:1284–1294.
21.
van Leeuwen PJ, Stricker P, Hruby G, et al. (68) Ga-PSMA has a high detection rate of
prostate cancer recurrence outside the prostatic fossa in patients being considered for
salvage radiation treatment. BJU Int. 2016;117:732–739.


Version date: 2016.07.11
Protocol CC#: 165510 
Phase II – 68Ga-PSMA-11
Page 25 of 29
Appendices
Appendix 1 Performance Status Criteria
ECOG Performance Status Scale
Karnofsky Performance Scale
Grade
Descriptions
Percent
Description
100
Normal, no complaints, no evidence 
of disease
0
Normal activity
Fully active, able to carry on all 
pre-disease performance without 
restriction
90
Able to carry on normal activity; 
minor signs or symptoms of disease
80
Normal activity with effort; some 
signs or symptoms of disease
1
Symptoms, but ambulatory
Restricted in physically strenuous 
activity, but ambulatory and able 
to carry out work of a light or 
sedentary nature (e.g., light 
housework, office work)
70
Cares for self, unable to carry on 
normal activity or to do active work
60
Requires occasional assistance, but 
is able to care for most of his/her 
needs
2
In bed < 50% of the time
Ambulatory and capable of all 
self-care, but unable to carry out 
any work activities
Up and about more than 50% of 
waking hours
50
Requires considerable assistance 
and frequent medical care
40
Disabled, requires special care and 
assistance
3
In bed > 50% of the time
Capable of only limited self-care, 
confined to bed or chair more 
than 50% of waking hours
30
Severely disabled, hospitalization 
indicated
Death not imminent
20
Very sick, hospitalization indicated
Death not imminent
4
100% bedridden
Completely disabled
Cannot carry on any self-care
Totally confined to bed or chair
10
Moribund, fatal processes 
progressing rapidly
5
Dead
0
Dead


Version date: 2016.07.11
Protocol CC#: 165510 
Phase II – 68Ga-PSMA-11
Page 26 of 29
Appendix 2 (flow chart)
Bone: Further 
imaging of 
suspected bone 
metastasis by MRI 
(and/or repeat 
68Ga-PSMA-11 as 
allowable).
Target Lesion(s) - 
HP/Biopsy 
Positive 
68Ga-PSMA-11 PET 
Positive Regions 2-4  
(see Table 1)
Target Lesion(s) –
HP/Biopsy 
Negative 
LN: If LN was resected, repeat 
dedicated CT or MRI (and/or 
repeat 68Ga-PSMA-11 PET as 
allowable) to determine if the 
PSMA PET positive node was 
removed.  If LN is still present on 
imaging then biopsy is considered 
false negative.  A repeat biopsy  
can be pursued.
3-12 month f/u conventional
imaging similar to initial 
staging modality (CT, bone 
scan and/or MRI)
68Ga-PSMA-11 PET 
Negative Regions 2-4
68Ga-PSMA-11 
PET Positive in 
Region 1 s/p -
Prostatectomy?
Yes
No
In case of Salvage Radiation
Therapy of the prostate bed: 
monitor PSA level to 6 months 
post-radiation to confirm PSA 
nadir < 0.05 ng/mL 
In case of no salvage radiation
therapy:
HP/Biopsy or 3-12 month f/u
conventional imaging similar to
initial staging modality (CT,
bone scan and/or MRI)
3-12 month f/u conventional imaging
similar to initial staging modality (CT,
bone scan and/or MRI)
3-12 month f/u
conventional imaging 
similar to initial staging 
modality (CT, bone scan 
and/or MRI)

Document change in clinical management
PCa BCR Study Entry Criteria:

Post-Prostatectomy (AUA criteria) – PSA >0.2 ng/mL x 2 measured more than 6 weeks after RP,  and
confirmatory persistent PSA greater than 0.2 ng/mL

Post-Radiation Therapy -  (ASTRO-Phoenix criteria) Nadir + ≥ 2 ng/mL

Contraindications to furosemide administration including allergies and adverse reactions(including sulfa drugs); Note:
furosemide can be omitted if second-generation scatter correction PET imaging is utilized.
68Ga-PSMA-11 PET Imaging
Positive imaging findings are aimed to be confirmed by histopathology(HP)/biopsy, if clinically feasible, and 
HP/Biopsy of accessible site(s) 


Version date: 2016.07.11
Protocol CC#: 165510 
Phase II – 68Ga-PSMA-11
Page 27 of 29
Appendix 3 (pre- and post-surveys)

ICF_001.pdf: 
Ga-68 HBED-CC PSMA: consent
Dated: 9/21/2017 (protocol version 1.10)
Page 1 of 9
Patient Name: ______________________
DOB:               _____ /______ /_________
UCSF MRN: _________________________
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
Evaluation of Gallium-68 HBED-CC Prostate Specific Membrane Antigen (PSMA) 
imaging in prostate cancer patients
WHAT IS THIS STUDY ABOUT?
This is a medical research study.  Your study doctor, 
, and his associates 
from the UCSF Department of Radiology will explain this study to you. Medical research 
studies include only people who choose to take part. Please take your time to make your 
decision about participating. You may discuss your decision with your friends, family, and 
health care team. If you have any questions, you may ask your study doctor.
You are being asked to participate in this study because you have been diagnosed with 
prostate cancer and there is clinical concern that you may have disease out side of the 
prostate. In this study we will be testing Gallium-68 PSMA PET (Positron Emission 
Tomography) imaging.  PSMA (or prostate specific membrane antigen) is a protein found 
on most prostate cancers.  Ga-68 PSMA is an imaging agent that binds to prostate cancer 
cells and can be imaged using PET.  A PET scan uses a special camera to detect energy given 
off from radioactive material to make detailed pictures of areas where the Ga-68 
accumulates in the body.  The PET scan if often combined with an MRI or CT scan, which 
helps to more accurately map the location of where in the body the radioactive material has 
collected.
Ga-68 PSMA is an experimental imaging agent that is not yet approved by the US Food and 
Drug Administration (FDA). 
WHY IS THIS STUDY BEING DONE?
The purpose of this study is:

To determine the ability of Ga-68 PSMA to detect the presence of prostate cancer
metastasis.
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?
Approximately 1,350 people will be enrolled in this study. 
IRB NUMBER: 15-17570
IRB APPROVAL DATE: 10/18/2017
IRB EXPIRATION DATE: 10/11/2018
NCT# 02918357


Ga-68 HBED-CC PSMA: consent
Dated: 9/21/2017 (protocol version 1.10)
Page 2 of 9
WHAT WILL HAPPEN TO ME IF I TAKE PART IN THIS RESEARCH STUDY? 
Before you begin the study...
To find out if you can be in the study, the following procedures with occur:

Medical chart review: Your medical chart will be reviewed by the study doctors.
Timeline: screening will occur within 30 days of the imaging study.  
On day 1, the PET imaging study will be performed which will take 
two and a half hours, and then one day later a follow-up phone call 
will be made to ask about adverse events.
During the main part of this study…
If the screening procedures show that you can continue to be in the study, and you choose 
to take part, then you will have the following tests and procedures done.  All study 
procedures will be done at UCSF China Basin Imaging Center in San Francisco, California, 
during a single study visit. 

Gallium-68 HBED-CC PMSA administration: A venous catheter will be placed in
your arm, and the Ga-68 PSMA will be given by intravenous (IV) injection.  
o
Your infusion will take about 1-2 minutes.

PET Imaging: A PET scan will be done around 60 minutes after the injection of the
Gallium-68 HBED-CC PSMA imaging agent. The pictures taken will allow researchers 
to look for tumors cells that accumulate the imaging agent. If you need it, you can get 
some medication from your referring provider, such as lorazepam (Ativan), to keep 
from feeling anxious or nervous during the scan.  During imaging you will be asked 
to lie still and may be asked to hold your breath for a few seconds.
o
At the time of receiving the imaging agent, you may be given Lasix through
your IV.  If you have known allergies to sulfa containing medications, please 
tell your study doctor as you may have an allergic reaction to Lasix. Lasix is 
administered in order to clear you urinary system and will make you urinate.   
IRB NUMBER: 15-17570
IRB APPROVAL DATE: 10/18/2017
IRB EXPIRATION DATE: 10/11/2018


Ga-68 HBED-CC PSMA: consent
Dated: 9/21/2017 (protocol version 1.10)
Page 3 of 9
You will feel the urge to urinate soon after administration.   Patients who 
cannot tolerate Lasix will not receive Lasix, and will be asked to drink water.

Imaging will be performed by either PET/CT or PET/MRI:
PET/MRI imaging:
o
Imaging will be performed using a PET/MRI, which will take 50 to 60
minutes to complete.  Prior to the PET/MRI scan you will be asked to remove 
all metal from your clothing, pockets, shoes, and person.  You will be asked to 
wear clothing compatible with the PET/MRI environment.  You will be 
provided with earplugs or headphones that you must wear during the entire 
scan.  Protective padding will be placed between your body and the inner 
walls of the scanner.  During the scan you will hear loud sounds that are a 
normal part of the scan. 
o
For PET/MRI you may receive a gadolinium based contrast agent (dye).
Intravenous (IV) contrast material is given to you by injecting the contrast 
material into a line that is attached to a needle in your arm, and is used to get 
clearer pictures of your body cavity.
PET/CT imaging:
o
Imaging will be performed using a PET/CT, which will take 30 to 40 minutes
to complete.  Imaging of your whole body will be obtained.  During imaging 
you will lay flat on a table inside the PET/CT machine.
o
For PET/CT you may receive an iodinated contrast agent (dye).  Intravenous
(IV) contrast material is given to you by injecting the contrast material into a
line that is attached to a needle in your arm, and is used to get clearer 
pictures of your body cavity.  It is standard of care at UCSF to receive 
iodinated contrast with a PET/CT.
You will be contacted by phone one to three days after the study to determine if you 
experienced any adverse events.  If a node near the prostate was noted on imaging with 
PSMA PET and the node was not removed at surgery, you will be reimaged using CT in 
order to determine if the abnormal node was removed.  We will reimage you because it is 
important to determine if the abnormal node was removed or not in terms of additional 
treatment planning as well as helping determine the accuracy of the PSMA imaging study. 
Additionally, you may be imaged using CT or MRI 6-12 months after PSMA imaging to see if 
your tumors change in size on therapy.  For some participants, your referring clinician will 
be contact before and after the PSMA imaging study to complete surveys to help us 
understand the impact of PSMA PET on your care.  Finally we will review your medical 
records and follow-up imaging after the PSMA PET to determine the accuracy of the 
imaging study.
HOW LONG WILL I BE IN THE STUDY?
Screening will take place within 30 days of the study.  The imaging and follow-up phone 
call will take two days or until you decide to withdraw your consent for participation in this 
IRB NUMBER: 15-17570
IRB APPROVAL DATE: 10/18/2017
IRB EXPIRATION DATE: 10/11/2018


Ga-68 HBED-CC PSMA: consent
Dated: 9/21/2017 (protocol version 1.10)
Page 4 of 9
study.  The imaging day will take roughly three hours to complete.  Withdrawing your 
consent to participate in this study will not affect your medical care/treatment whatsoever, 
and your doctor will continue to follow you as a patient. You can stop taking part in this 
study at any time. If you decide to stop taking part in the study, we encourage you to talk to 
your medical team first.
CAN I STOP BEING IN THE STUDY?
Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about 
stopping or decide to stop. He or she will tell you how to stop your participation safely. The 
study doctor may stop you from taking part in this study at any time if he/she believes it is 
in your best interest, if you do not follow the study rules, or if the study is stopped.
WHAT SIDE EFFECTS OR RISKS CAN I EXPECT FROM BEING IN THE STUDY?
You may have side effects while on the study. Every one taking part in the study will be 
watched carefully for any side effects. However, doctors don't know all the side effects that 
may happen. Side effects may be mild or serious. Your health care team may give you 
medicines to help lessen side effects. You should talk to your study doctor about any side 
effects you experience while taking part in the study. There also is a risk of death.
Risks and side effects related to Gallium-68 HBED-CC PSMA administration include:

Transient nausea and diarrhea: patients have reported developing nausea and
diarrhea after injection of Gallium labeled compounds.   In all cases this has resolved 
without intervention within 45 minutes.  

Radiation risks: This research study involves exposure to radiation Gallium-68
HBED-CC PSMA administration. This radiation exposure is not necessary for your 
medical care and is for research purposes only. The additional amount of radiation 
that you will receive as a result of participating in this study will be a maximum of 
approximately 6.1 mSv, which is slightly more than 2 times the yearly natural 
background of radiation in the US, which is 3 mSv (a mSv, or milliSievert, is a 
measurement of radiation).  This amount of radiation may involve a low risk of 
cancer.  If you have any questions regarding the use of radiation or the risks 
involved, please consult the physician conducting the study.

Placement of venous catheter: The placement of a venous catheter is associated
with the development of bruising and infection.  It may also be associated with a risk 
of bleeding. 
Risks and side effects related to the imaging procedures:

PET/MR scan risks (MRI imaging only):  MR imaging is safe; but accidents,
injuries, and deaths have occurred during MRI procedures.  These events are rare, 
especially if appropriate safety precautions are followed.  More specifically:
IRB NUMBER: 15-17570
IRB APPROVAL DATE: 10/18/2017
IRB EXPIRATION DATE: 10/11/2018


Ga-68 HBED-CC PSMA: consent
Dated: 9/21/2017 (protocol version 1.10)
Page 5 of 9
o
Metallic objects: Study staff will determine if it is safe for you to enter the
PET/MRI environment. It is extremely important that you answer their
questions completely.
o
Heating and burns: In order to minimize the chances of warming or burns,
padding will be placed between you and the bore wall of the magnet.
o
Tingling sensation: Discomforts associated with certain PET/MRI scanning
techniques may include a temporary tingling sensation in certain parts of the 
body including, but not limited to, the arms, legs, fingertips, and nose.  This 
sensation is not expected to last long and is typically not painful. 
o
Noises: Discomforts associated with certain PET/MRI scanning techniques
may include listening to loud noises made by the scanner during the scanning 
procedure. You will be provided with earplugs to minimize the noise.  If the 
noise is uncomfortable for you, please ask the PET/MRI Scan Operator to 
discontinue the scan.
o
No know effects adverse effects of magnetic fields: There is no evidence
in scientific literature that individual or even frequent repeated exposures to 
high static magnetic fields poses a health concern. 

MRI contrast administration (MRI imaging only): Intravenous contrast will be
administered through the venous catheter during the PET scan.  The most common 
adverse reactions are nausea, feeling “hot”, headaches and abnormal tastes.  These 
agents also have known rare risks that severe allergic reactions and a disease called 
nephrogenic systemic fibrosis (NSF).  NSF can be prevented by not administering 
gadolinium based contrast agents to patients with renal disease.  Your renal 
function will be checked, and the agent will not be administered if you have renal 
disease.

CT contrast administration (CT imaging only): Contrast material (iodine dye) is
associated with a slight risk of developing an allergic reaction, from mild (itching, 
rash) to severe (difficulty breathing, shock, or rarely, death).  The contrast material 
may also cause kidney problems, especially if you are dehydrated or have poor 
kidney function.  The study doctors will ask you about any allergies or related 
conditions before the procedure.  If you have any of these problems or severe 
kidney disease, you may not receive contrast material as part of the study.

CT radiation risks (CT imaging only): Imaging using a PET/CT adds additional
radiation dose to the imaging study. This radiation exposure is not necessary for 
your medical care and is for research purposes only. The additional amount of 
radiation that you will receive as a result of participating in this study will be a 
maximum of approximately 4.5 mSv, which is less than 2 times the yearly natural 
background of radiation in the US, which is 3 mSv (a mSv, or milliSievert, is a 
measurement of radiation).  This amount of radiation may involve a low risk of 
cancer.  If you have any questions regarding the use of radiation or the risks 
involved, please consult the physician conducting the study.

Detection of new lesions and incidental findings: The Ga-68 HBED-CC PSMA
imaging may detect previously unknown lesions.  A report will be created describing 
the imaging findings and will be added to your medical record.  New unexpected 
IRB NUMBER: 15-17570
IRB APPROVAL DATE: 10/18/2017
IRB EXPIRATION DATE: 10/11/2018


Ga-68 HBED-CC PSMA: consent
Dated: 9/21/2017 (protocol version 1.10)
Page 6 of 9
findings may affect your care, and your referring clinician will discuss the results of 
this imaging study with you.  These findings may lead to additional and unnecessary 
biopsies.

Unknown Risks: The experimental imaging may have side effects that no one
knows about yet. The researchers will let you know if they learn anything that might
make you change your mind about participating in the study.
For more information about risks and side effects, ask your study doctor.
ARE THERE BENEFITS TO BEING IN THE STUDY?
There may be a medical benefit to you.  The information obtained from the Gallium-68 
PSMA imaging may provide additional information about sites of your disease compared to 
conventional imaging agents.  Your images will be reviewed by a radiologist and nuclear 
medicine physician and a report will be sent to your referring clinician.  These images will 
be available to your treating physician, and will be used in addition to conventional 
imaging studies to make clinical decisions.   Additionally, the information learned from this 
study may benefit other patients with prostate cancer in the future by improving the 
quality and availability of imaging agents.
WHAT OTHER CHOICES DO I HAVE IF I DO NOT TAKE PART IN THIS STUDY?
You can chose to not enroll in this study.  In this case you may be staged using standard of 
care imaging including CT, MRI, PET/CT and/or bone scans.
WILL MY MEDICAL INFORMATION BE KEPT PRIVATE?
Participation in research involves some loss of privacy.  We will do our best to make sure 
that information about you is kept confidential, but we cannot guarantee total privacy.  
Some information from your medical records will be collected and used for this study.  If 
you do not have a UCSF medical record, one will be created for you.  Your signed consent 
form and some of your research tests will be added to your UCSF medical record.  
Therefore, people involved with your future care and insurance may become aware of your 
participation and of any information added to your medical record as a result of your 
participation.  Study tests that are performed by research labs, and information gathered 
directly from you by the researchers will be part of your research records but will not be 
added to your medical record.  Your personal information may be given out if required by 
law.  If information from this study is published or presented at scientific meetings, your 
name and other personal information will not be used.
Organizations that may look at and/or copy your medical records for research, quality 
assurance, and data analysis include:

The UCSF Committee on Human Research

The UCSF Helen Diller Family Comprehensive Cancer Center
IRB NUMBER: 15-17570
IRB APPROVAL DATE: 10/18/2017
IRB EXPIRATION DATE: 10/11/2018


Ga-68 HBED-CC PSMA: consent
Dated: 9/21/2017 (protocol version 1.10)
Page 7 of 9

The University of California

The National Cancer Institute (NCI) and other governmental agencies, like the Food
and Drug Administration (FDA), involved in keeping research safe for people.

The Society of Nuclear Medicine and Molecular Imaging
WHAT ARE THE COSTS OF TAKING PART IN THIS STUDY?
You and/or your health plan/insurance company will need to pay for some or all of the 
costs of treating your cancer in this study.  The cost of the imaging study will be charged to 
you or your health plan/insurance company, with an estimated cost of $6,000 for PET/MRI 
and $4,000 for PET/CT.  Prior to the study being performed, your health plan/insurance 
company will be contacted to attempt to obtain preauthorization.  If insurance 
authorization is not obtained, you will have the option to pay out of pocket for the imaging 
component of the study or undergo the standard of care imaging, which is likely to be 
covered by insurance.  You will be notified of the insurance company pre-authorization 
decision prior to the imaging study taking place.  If you have any questions in regards to 
billing and authorizations, please contact the radiology billing office (415) 514-8888.
For more information on clinical trials and insurance coverage, you can visit the National 
Cancer Institute's Web site at http://cancer.gov/clinicaltrials/understanding/insurance-
coverage. You can print a copy of the "Clinical Trials and Insurance Coverage" information 
from this Web site.
Another way to get the information is to call 1-800-4-CANCER (1-800-422-6237) and ask 
them to send you a free copy.
WILL I BE PAID FOR TAKING PART IN THIS STUDY?
You will not be paid for taking part in this study.
WHAT HAPPENS IF I AM INJURED BECAUSE I TOOK PART IN THIS STUDY?
It is important that you tell your study doctor,
, if you feel that you have 
been injured because of taking part in this study.  You can contact your study doctor 
Treatment and Compensation for Injury:  If you are injured as a result of being in this 
study, the University of California will provide necessary medical treatment.  The costs of 
the treatment may be billed to you or your insurer just like any other medical costs, or 
covered by the University of California, depending on a number of factors.  The University 
and the study sponsor do not normally provide any other form of compensation for injury.  
For further information about this, you may call the office of the Committee on Human 
Research 
.  
IRB NUMBER: 15-17570
IRB APPROVAL DATE: 10/18/2017
IRB EXPIRATION DATE: 10/11/2018


Ga-68 HBED-CC PSMA: consent
Dated: 9/21/2017 (protocol version 1.10)
Page 8 of 9
WHAT ARE MY RIGHTS IF I TAKE PART IN THIS STUDY?
Taking part in this study is your choice. You may choose either to take part or not to take 
part in the study. If you decide to take part in this study, you may leave the study at any 
time. No matter what decision you make, there will be no penalty to you and you will not 
lose any of your regular benefits. Leaving the study will not affect your medical care. You 
can still get your medical care from our institution.
We will tell you about new information or changes in the study that may affect your health 
or your willingness to continue in the study.
In the case of injury resulting from this study, you do not lose any of your legal rights to 
seek payment by signing this form.
WHO CAN ANSWER MY QUESTIONS ABOUT THE STUDY?
You can talk to your study doctor about any questions or concerns you have about this 
study. Contact your study doctor,
For questions about your rights while taking part in this study, call the UCSF Committee on 
Human Research (a group of people who review the research to protect your rights) at 
.
CONSENT
You have been given copies of this consent form and the Experimental Subject's Bill of 
Rights to keep.
You will be asked to sign a separate form authorizing access, use, creation, or disclosure of 
health information about you.
PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to participate 
or to withdraw at any point in this study without penalty or loss of benefits to which you 
are otherwise entitled.
If you wish to participate in this study, you should sign below.
Date
Participant's Signature for Consent
IRB NUMBER: 15-17570
IRB APPROVAL DATE: 10/18/2017
IRB EXPIRATION DATE: 10/11/2018


Ga-68 HBED-CC PSMA: consent
Dated: 9/21/2017 (protocol version 1.10)
Page 9 of 9
Date
Person Obtaining Consent
Date
Witness – Only required if the participant is a non-English speaker
IRB NUMBER: 15-17570
IRB APPROVAL DATE: 10/18/2017
IRB EXPIRATION DATE: 10/11/2018