The Role of 68Ga-PSMA-11 PET in Surgery Guidance in Prostate Cancer: A Prospective Pilot Trial
Phase: PHASE2
Conditions: Prostate Cancer
Sponsor: Clinton Bahler

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The Role of 68Ga-PSMA-11 PET in Surgery Guidance in Prostate 
Cancer: A prospective Pilot trial 
INDIANA UNIVERSITY PROTOCOL  
IUSCCC-0760, IRB#11330 
Principal 
Investigator: 
Clinton D. Bahler, MD, MS 
Assistant Professor of Urology 
Indiana University School of Medicine 
535 Barnhill Dr., Ste 420 
Indianapolis, IN 46202 
Cell: 317.313.5405 
Office: 317.944.3458 
Fax: 317.944.0174 
cdbahler@iupui.edu 
Co-investigators: 
Michael Koch, MD 
Professor of Urology 
mkoch2@IUHealth.org 
 
Mark Tann, MD 
Professor of Radiology 
matann@iupui.edu 
 
Mark Green, PhD 
Professor of Radiology 
magreen@iu.edu 
 
Gary Hutchins, PhD 
Professor of Radiology, Vice Chair of Research 
gdhutchi@iupui.edu 
 

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Liang Cheng, MD 
Virgil H. Moon Professor of Pathology, Department of Pathology 
and Laboratory Medicine 
lcheng@iu.edu; liang_cheng@yahoo.com 
 
Jordan Swensson, MD  
Assistant Professor of Radiology 
jswensso@iupui.edu 
 
Justin Sims, MD 
Assistant Professor of Clinical Radiology 
simsjb@iupui.edu  
 
Jason Parker, PhD 
Associate Professor, Director of Diagnostic Physics, Dept. 
of Radiology 
parkerjg@iu.edu 
 
Hao Liu, PhD  
Professor of Biostatistics 
hl15@iu.edu 
 
Yan Tong, PhD, MS 
Biostatistician, Department of Biostatistics 
tongy@iu.edu 
 
 
 
 
Support: 
Indiana University Departments of Urology, Radiology, and 
Pathology 
 
American Cancer Society 
Institutional Research Grant # 19-144-34-IRG ($40,000) 
 
IND#: 
141706 
 
Date of Protocol: 
March 29, 2022 
 
 

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INVESTIGATOR’S AGREEMENT 
By signing below, I confirm that I have read this protocol and agree: 
• To assume responsibility for the proper conduct of this study at this site 
• To conduct the study according to the procedures described in this protocol 
and any future amendments 
• Not to implement any deviation from, or changes to, the protocol without written 
approval from the Institutional Review Board (IRB), except where necessary to 
eliminate immediate hazard to the subject(s) 
• That I am aware of all updates and will comply with all applicable regulations 
and guidelines 
 
 
 
Principal investigator’s signature 
 
Date 
Clinton D. Bahler, MD, MS 
 
 
Principal investigator’s name (print) 
 
 
Assistant Professor of Urology,  
Indiana University School of Medicine 
 
 
 
Principal investigator’s title (print) 
 
 
 
 

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PROTOCOL SYNOPSIS 
Study Design: 
Prospective, pilot phase 2 clinical trial, single arm (non-
randomized) 
Test 
Factor/Exposure: 
PSMA PET-CT: 68Ga-PSMA-11 PET-CT with Siemens Biograph 
Vision scanner or similar PET-CT to guide surgical planning.  This 
will be compared to the standard of care MRI.   
 
Duration of 
Treatment: 
Patients will undergo injection of 68Ga-PSMA-11 PET-CT prior to 
definitive surgery.  Quality-of-life will be tracked through 12-months 
follow-up. 
Enrollment: 
n=55 
Primary Objective 
and Endpoint: 
Objective:  
Obtain PSMA-PET imaging 
preoperatively and calculate 
performance for predicting extra-
prostatic extension based on 
whole-mount pathology (gold 
standard).   
Endpoint:  
Sensitivity and Specificity for 
detecting extra-prostatic 
extension of cancer at the 
nerve bundles 
 
Secondary 
Objectives and 
endpoints 
 
 
 
 
 
 
 
 
 
 
Exploratory 
Objectives:  
1) Quantify the frequency of 
proper treatment changes 
directed by PSMA-PET, 
focusing on appropriate 
preservation of surrounding 
structures important for 
genito-urinary function 
including: 1) Bladder neck, 2) 
Nerve bundles, 3) Urethral 
Sphincter (Figure 4).  
 
 
2) Directly compare PSMA-PET 
performance for predicting extra-
prostatic extension to standard-
of-care assessments. 
Endpoints: 
1) Rate of treatment changes 
and rate of treatment changes 
that were appropriate based 
on pathology. 
 
 
 
 
 
 
 
 
2) Sensitivity/ Specificity/ 
PPV/ NPV for PSMA-PET vs. 
MRI vs. ultrasound-based 
nomogram. 

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3) Assess quality of life changes 
from preoperative baseline. 
4) To assess whether kinetic 
modeling tools are useful for 
improving detection of the 
location and extent of tumor in 
68Ga-PSMA-11 PET/CT images 
(going beyond the standard PET 
map of regional radiotracer 
concentrations, additionally 
examining differences in regional 
pharmacokinetics to possibly 
further differentiate benign and 
neoplastic tissue). 
 
3) Quality-of-life: IIEF-15 
(Erectile function score), 
EPIC-26 (Pad use), SF-36 
(overall mental and physical 
health domains). 
4) Qualitative and quantitative 
changes in PET image 
appearance after voxel-by-
voxel application of kinetic 
modeling tools to define 
regional pharmacokinetics 
(compared to standard PET 
reconstructions showing 
simply the integrated 
concentration of regional 
radioactivity over the imaging 
period). 
Inclusion Criteria: 
1. Men diagnosed with clinically significant prostate cancer 
who are scheduled or scheduling for prostatectomy 
2. Prostate pathology results consistent with: 
a. Gleason 3+4 ≥1 core with pattern 4 ≥20% or 
b. >3 cores of Gleason 3+4 or 
c. NCCN unfavorable intermediate risk or 
d. NCCN high-risk or 
e. NCCN very-high risk 
3. Scheduled for standard of care MRI or has recently 
completed standard of care MRI (within 6 months). 
Willing and able to lie still for approximately 50 minutes in 
an enclosed space for the PET/CT and MRI 
Exclusion Criteria: 
1. Participation in another investigational trial involving 
research exposure to ionizing radiation concurrently or 
within 30 days. 
2. Does not meet safety criteria for MRI scan (e.g. metal 
implant that could affect prostate imaging). 
3. Significant acute or chronic medical, neurologic, or  
     illness in the subject that, in the judgment of the Principal    
     Investigator, could compromise subject safety, limit the 
ability to complete the study, and/or compromise the 
objectives of the study. 

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Number of Sites: 
Indiana University Simon Cancer Center, IU Health University 
Hospital, IU Health North, IU Health North medical office building, 
IU Health Schwarz Cancer Center, IU Health Methodist Hospital, 
IU Health Neuroscience Center/Goodman Hall 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1 
TABLE OF CONTENTS 
INVESTIGATOR’S AGREEMENT .................................................................................................................................... 3 
PROTOCOL SYNOPSIS ...................................................................................................................................................... 4 
1 
TABLE OF CONTENTS .............................................................................................................................................. 7 
2 
SCHEMA ......................................................................................................................................................................... 9 
3 
BACKGROUND ............................................................................................................................................................. 9 
3.1 
BACKGROUND & PRELIMINARY WORK ............................................................................................................................. 10 
3.2 
RATIONALE ................................................................................................................................................................................. 14 
4 
STUDY OBJECTIVES ............................................................................................................................................... 14 
4.1 
PRIMARY ..................................................................................................................................................................................... 15 
4.2 
SECONDARY .............................................................................................................................................................................. 15 
4.3 
EXPLORATORY ............................................................................................................... ERROR! BOOKMARK NOT DEFINED. 
5 
ELIGIBILITY CRITERIA ............................................................................................................................................ 16 
5.1 
INCLUSION CRITERIA .............................................................................................................................................................. 16 
5.2 
EXCLUSION CRITERIA ............................................................................................................................................................. 16 
6 
PATIENT REGISTRATION ...................................................................................................................................... 17 
7 
STUDY PROCEDURES ............................................................................................................................................ 17 
7.1 
SUMMARY ................................................................................................................................................................................... 17 
7.2 
STUDY CALENDAR ................................................................................................................................................................... 18 
7.3 
ASSESSMENTS BY VISIT ........................................................................................................................................................ 19 
8 
STUDY WITHDRAWAL/DISCONTINUATION ................................................................................................... 22 
9 
STATISTICAL CONSIDERATIONS ...................................................................................................................... 22 
9.1 
STUDY DESIGN ......................................................................................................................................................................... 22 
9.2 
STUDY POPULATION ............................................................................................................................................................... 23 
9.3 
SAMPLE SIZE ............................................................................................................................................................................. 23 
9.4 
STUDY ENDPOINTS ...................................................................................................... ERROR! BOOKMARK NOT DEFINED. 
9.5 
PARTICIPANT CHARACTERISTICS ....................................................................................................................................... 23 
9.6 
CONCOMITANT MEDICATIONS .................................................................................. ERROR! BOOKMARK NOT DEFINED. 
9.7 
ANALYSIS OF PRIMARY OBJECTIVE ................................................................................................................................... 23 
9.8 
ANALYSIS OF SECONDARY OBJECTIVES ......................................................................................................................... 23 
10 
DATA FORMS AND SUBMISSION SCHEDULE ......................................................................................... 24 
11 
DATA AND SAFETY MONITORING PLAN ................................................................................................... 24 
11.1 
IND ANNUAL REPORTS ......................................................................................................................................................... 25 
11.2 
STUDY AUDITING AND MONITORING ................................................................................................................................. 25 

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11.3 
DATA MANAGEMENT/ONCORE REPORTING REQUIREMENTS ................................................................................. 25 
11.4 
ONCORE SAFETY REPORTING ........................................................................................................................................... 26 
11.5 
STUDY ACCRUAL OVERSIGHT ............................................................................................................................................. 26 
11.6 
PROTOCOL DEVIATION REPORTING ................................................................................................................................. 26 
12 
ADVERSE EVENTS .............................................................................................................................................. 26 
12.1 
DEFINITIONS OF ADVERSE EVENTS .................................................................................................................................. 26 
12.2 
ADVERSE EVENT REPORTING REQUIREMENTS: .......................................................................................................... 28 
13 
PATIENT CONSENT AND PEER JUDGEMENT ......................................................................................... 29 
14 
REFERENCES ........................................................................................................................................................ 29 
15 
APPENDICES ......................................................................................................................................................... 32 
15.1 
APPENDIX A ............................................................................................................................................................................... 32 
15.2 
APPENDIX B .................................................................................................................... ERROR! BOOKMARK NOT DEFINED. 
15.3 
APPENDIX C .................................................................................................................... ERROR! BOOKMARK NOT DEFINED. 
15.4 
APPENDIX D .................................................................................................................... ERROR! BOOKMARK NOT DEFINED. 
 
 

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2 
SCHEMA  
 
 
 
 

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3 
BACKGROUND 
3.1 
Background & Preliminary Work 
Metastatic prostate cancer rates have dropped significantly over the past 30-years, due 
to early aggressive prostatectomy and radiation therapy. However, hundreds of 
thousands of survivors have significant treatment-related side-effects, including urinary 
incontinence and erectile dysfunction.  Treatment related side-effects result from 
collateral damage to structures alongside the prostate, such as nerves (erections) and 
sphincter muscle (incontinence).  Injury or wide resection of sphincter and nerves is 
frequently intentional, or planned, to ensure all cancer is removed; yet, in hindsight it 
often appears this wide resection was not required.  That is, a high percentage of the 
time the cancer is not extending outside the prostate as suspected or feared from 
biopsy and imaging-based staging.  Prostate cancer is unique — most cases of extra-
prostatic extension (extension into muscle and nerves) is not visible either on standard 
preoperative imaging, or to the operating surgeon during resection.  Extra-prostatic 
extension is instead discovered on pathologic analysis after the patient has left the 
operating room.  Prostate cancer has other unique features that make operative 
planning difficult: (1) it is multi-focal in up to 80% of subjects (Fig. 1); (2) it often 
presents with mixed grade lesions (Fig. 1); and (3) conventional imaging modalities 
(ultrasound, MRI) can miss significant cancers entirely. 
 
Hundreds of thousands of men could have 
peace of mind and improved outcomes, if 
new imaging could accurately detect extra-
prostatic extension of prostate cancer to 
better guide treatment.  Recent studies on 
treatment-related regret in prostate cancer 
show key drivers of regret are: nerve related 
injury (erectile dysfunction), loss of 
masculinity, and positive surgical margins 
(van Stan, et al. 2020, Baunake, et al. 2020). 
Cellularly targeted molecular imaging 
(PSMA-PET) appears to have the needed 
ability to detect aggressive prostate cancer, 
but requires further testing to validate its 
usefulness in surgical guidance.  
 
 
Figure 1. Whole-mount pathology slide 

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INNOVATION 
 
We currently use multiparametric 3-T MRI (mpMRI), in addition to ultrasound biopsies, 
to guide surgical therapy, but significant uncertainty remains due to limited sensitivity.  
Incorporating MRI-guidance does increase the detection of clinically significant prostate 
cancer compared to systematic biopsy alone (Hu, et al. 2014, Pokorny, et al. 2017, 
Wysock, et al. 2014).  However, recent studies mapping MRI lesions to final whole-
mount pathology show significant limitations remain with this imaging approach.  For 
example, a recent study showed only 80% of index (largest) tumors were seen by MRI, 
and even fewer secondary lesions (Le, et al. 2014).  Another recent study showed MRI 
missed a clinically significant lesion in 26% of patients using whole-mount analysis 
(Borofsky, et al. 2017).  Fittingly, Borofsky titled their paper, “What are we missing? 
False negative cancers at Multiparametric MR imaging of the prostate.”  MRI 
interpretation has also been shown to vary substantially between radiologists, which 
persisted after correcting for radiologist practice volume (Sonn, et al. 2017, Sonn, et al. 
2020). 
 
We have performed thousands of prostatectomies at Indiana University and note that 
many patients have “prostate confined” cancer that could have been cured with nerve 
sparing treatment.  The converse is also concerningly true: many patients have positive 
surgical margins where nerve sparing surgery was performed at sites of extra-prostate 
extension leaving cancer behind.  We were early investigators of PSMA-PET imaging, 
and since 2017 have been observing whether PSMA-PET could aid in surgical 
resection.  Using a molecular targeted agent such as 68Ga-PSMA-11 to guide 
resection represents a significant innovation in surgical planning, appearing to 
offer better individualization of the treatment plan with reduced surgical margins, 
when appropriate, and consequently improving quality of life. 
 
Preliminary Studies 
PSMA PET imaging in primary prostate cancer has been reported primarily out of 
Germany and Australia with few prospective studies in the United States.  Few studies 
utilize the labor-intensive whole-mount pathology as the “gold standard” for rigorous 
disease characterization, and few studies have comprehensively looked specifically at 
extra-prostatic extension and surgical resection guidance.  Furthermore, the published 
studies have focused on a small percentage of aggressive prostate cancer (high-risk 
disease) rather than the majority of pre-metastatic cancers (intermediate risk disease).  
For example, the only study reported out of the United States was a retrospective 

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review of 32 higher risk aggressive cancers (≥4+3) removed by prostatectomy, which 
found PSMA PET-MRI to be superior to mpMRI (Sensitivity 74% vs 50%, p<0.001, 
Hicks, et al. 2018).  A retrospective trial out of Australia compared 68Ga-PSMA-11 PET-
CT and mpMRI using a per lesion approach (Berger, et al. 2018).  They found index 
lesion localization was better for PSMA-PET than MRI (100% vs 94%).  Secondary 
lesion sensitivity was much higher for PSMA-PET than for MRI (94% vs 52%).  We 
need larger prospective studies focused on improved surgical guidance in the patient 
population posing the greatest challenge in urologic decision-making, patients with 
intermediate risk disease. 
Preliminary Studies/Data 
68Ga-PSMA-11 PET for Early Metastatic Disease.  The project investigators have 
significant experience in PET imaging with 68Ga-PSMA-11. Our initial human experience 
with 68Ga-PSMA-11 PET was for dosimetry assessment, studying ten prostate cancer 
patients with biochemical recurrence who had been previously clinically imaged with 
11C-acetate under an Expanded Access IND (Green, et al. 2017). The expected utility of 
68Ga-PSMA-11 PET was apparent even in that limited series, with 68Ga detecting sites 
of metastasis not seen in 11C-acetate imaging.  We have subsequently dropped 11C-
acetate imaging in prostate cancer patients with biochemical recurrence in favor of 
68Ga-PSMA-11 PET, and have performed clinical imaging on over 400 patients under 
Expanded Access IND 131,806.  
68Ga-PSMA-11 PET for Diagnosis and Surgical Planning. We recently published an 
observational trial evaluating 68Ga-PSMA-11 PET-CT or PET-MRI preoperatively in 15 
patients with biopsy-proven high or intermediate-risk prostate cancer (Bahler, et al. 
2019).  The PSMA-PET exam was obtained prior to scheduled surgical resection for 
correlation of imaging findings with whole-mount pathology.  All staging 68Ga-PSMA-11 
PET/CT scans (15/15) showed suspicious prostate lesions (index lesion) with median 
(IQR) SUV of 10.0 (6-13); benign prostate had a median (IQR) SUVmax of 2.2 (2-3).  
Good registration was seen between PSMA-PET and whole mount imaging for lethal 
cancer.  For secondary lesions, 8/11 (82%) were detected with 68Ga-PSMA-11 PET; the 
three missed lesions were of ≤10% Pattern 4 (>90% pattern 3).  Our study was 
published with the following Editorial Comment: “This study is…one of the few that has 
done so for intermediate risk disease and it delineates the accuracy of PSMA imaging to 
differentiate histological grade groups 1- 3.  Prospective well-designed trials 
validating PSMA imaging in these low prevalence populations are critical and a 
logical next step based on these study results” (Emmett and Hofman, 2020).  

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Figure 2. A 
lesion at the 
base of the 
prostate is seen 
(30% pattern 4) 
with 68Ga-
PSMA-11 PET-
CT scanner. 
 
68Ga-PSMA-11 PET for predicting extra-prostatic extension. Currently, we have 33 
prostatectomy cases (each case has right and left nerve bundle) available with 
preoperative PSMA-PET imaging.   Extra-prostatic extension was noted in 26/66 (39%) 
nerve bundles, and this was predicted in 24/26 (92%) of the cases on PSMA-PET.  The 
PSMA-PET would have changed the treatment plan in 18/33 (55%) of cases, including 
choosing to spare 12 nerve bundles, while also avoiding nerve sparing in 4 cases of 
extra-prostatic extension.  See Appendix A for example PSMA-PET surgeon’s report to 
guide resection. 
Figure 3. A lesion is noted along the left posterior near the nerve bundle but not the 
right.  Final pathology was 
consistent with the PSMA-PET 
showing extra-prostatic 
extension only on the left. This 
patient safely had right-sided 
nerve-sparing without positive 
margin due to the PET. 
 
 
 
Prostatectomy carries significant risk for post-treatment urinary and erectile dysfunction.  
PSMA-PET imaging offers the potential of both cancer control and excellent quality of 
life for patients whose disease is localized to the prostate. There is an immediate clinical 
need for validation of advanced imaging (PSMA-PET) in the context of enabling more 
precise surgical guidance.  
 
*E t
t ti
t
i

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3.2 
Rationale 
Our long-term goal is to improve cancer outcomes and quality of life for prostate cancer 
patients by bringing novel imaging agents and systems to the diagnosis and treatment 
of prostate cancer. Prostatectomy carries significant risk for post-treatment urinary and 
erectile dysfunction.  PSMA-PET imaging offers the potential of both cancer control and 
excellent quality of life for patients whose disease is localized to the prostate (see figure 
below). There is an immediate clinical need for validation of advanced imaging (PSMA-
PET) in the context of enabling more precise surgical guidance.  
 
 
 
 
 
 
 
 
 
 
Figure 4.  The prostate is located near several anatomic structures important for genito-
urinary function.  Advanced imaging is important to avoid unnecessary treatment of 
surrounding structures, while ensuring all malignant lesions are treated.  We aim to 
improve quality of life by appropriately avoiding injury to structures 1-4 shown at left.  
EPE = extra-prostatic extension. 
 
 
 

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4 
STUDY OBJECTIVES 
4.1 
Primary 
1) Evaluate PSMA-PET imaging preoperatively and calculate performance for 
predicting extra-prostatic extension based on the whole-mount pathology gold standard. 
4.2 
Secondary 
1) Quantify the frequency of proper treatment changes directed by PSMA-PET 
2) Compare PSMA-PET performance for predicting extra-prostatic extension to 
standard-of-care assessments. 
 
Exploratory Endpoints: 
3) Assess quality of life changes from preoperative baseline: 
 
IEF-15 (Erectile function score),  
 
EPIC-26 (Pad use),  
 
SF-36 (Overall mental and physical health domains) 
 
4) To assess whether kinetic modeling tools are useful for improving detection of 
the location and extent of tumor in 68Ga-PSMA-11 PET/CT images. (Going beyond the 
standard PET map of regional radiotracer concentrations, to additionally examine 
differences in regional pharmacokinetics in order to possibly better differentiate benign 
and neoplastic tissue.) 
 
5 
CRITERIA FOR EVALUATION 
5.1 
Primary 
1) Sensitivity and Specificity of PSMA-PET imaging for detecting extra-prostatic extension of 
cancer at the nerve bundles 
5.2 
Secondary 
1) Rate of treatment changes and rate of treatment changes that were appropriate 
based on pathology. 

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Exploratory Endpoints 
2) Sensitivity/ Specificity/ PPV/ NPV for PSMA-PET vs. MRI vs. ultrasound-based 
nomogram. 
3) IIEF-15 (Erectile function score), EPIC-26 (Pad use), SF-36 (overall mental and 
physical health domains). 
4) Qualitative and quantitative evaluation of changes in PET image appearance after 
voxel-by-voxel application of kinetic modeling tools to define regional pharmacokinetics 
(compared to standard PET reconstructions showing simply the integrated 
concentration of regional radioactivity over the imaging period). 
 
6 
ELIGIBILITY CRITERIA 
6.1 
Inclusion Criteria 
To be considered eligible to participate in this study, a patient must meet all the 
inclusion criteria listed below: 
1. Men diagnosed with clinically significant prostate cancer and are scheduling 
prostatectomy. 
2. Prostate pathology results consistent with: 
a. Gleason 3+4 ≥1 core with pattern 4 ≥20% or 
b. > 3 cores of Gleason 3+4 or 
c. NCCN unfavorable intermediate risk or 
d. NCCN high-risk or 
e. NCCN very-high risk 
3. Scheduled for standard of care MRI or has recently completed standard of care 
MRI (within 6 months).  Willing and able to lie still for approximately 50 minutes in 
an enclosed space for the MRI. 
6.2 
Exclusion Criteria 
1. Participation in another investigational trial involving research exposure to 
ionizing radiation concurrently or within 30 days. 
2. Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed, 
since this is required for comparison). 
3. Significant acute or chronic medical, neurologic, or illness in the subject that, in 
the judgment of the Principal Investigator, could compromise subject safety, limit 
the ability to complete the study, and/or compromise the objectives of the study. 

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7 
PATIENT REGISTRATION 
Patient enrollment will take place over 12 months at a single institution – Indiana 
University Simon Cancer Center (IUSCC) encompassing Indiana University Hospital 
(IUH), IU Health North, IU Health North medical office building, IU Health Methodist 
Hospital and IU Health Neuroscience Center/Goodman Hall, and IU Health Schwarz 
Cancer Center. Potential patients will be identified in the Urology clinic, or by physician 
referrals, mostly likely but not exclusively during pre-operative consultations for surgical 
removal of prostate cancer. All study procedures will take place at IUSCC/IUH/IU-Health 
Methodist Hospital, with the research imaging performed at the IU Health Goodman Hall 
outpatient facility or R2 research facility within the Indiana University Department of 
Radiology and Imagining Sciences.  All patients will be registered with the Indiana 
University (IU) Department of Urology. Regulatory files will be maintained by the 
Department of Urology. Applicable regulatory documents must be completed and on file 
prior to registration of any patients. Patients who appear to be eligible for this trial will 
undergo the Informed Consent Process and be screened for eligibility utilizing the 
Eligibility Criteria. Individual patient registration will be done in the REDCap database. 
The original signed Institutional Review Board (IRB) approved Informed Consent 
Document and completed eligibility checklist will be stored in the following location: 
Indiana University Department of Urology, 535 N. Barnhill Dr., Ste 150, Indianapolis, IN, 
46202. 
8 
STUDY PROCEDURES 
8.1 
Summary 
This patient population will have clinically significant prostate cancer and either already 
be scheduled for, or in the process of scheduling a prostatectomy.  Patients will either 
have recently had (within 6-months) a standard of care prostate MRI as part of routine 
care for their prostate cancer. Following the informed consent process, patients who 
enroll in the study will receive a 68Ga-PSMA-11 PET-CT.  The sensitivity and specificity 
for lesion characterization will be evaluated, along with the ability of the tracer to inform 
the treatment planning.  After patients undergo surgical removal of the prostate it will 
have a slice-by-slice whole mount analysis to assess the sensitivity and specificity the 
PSMA PET.

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8.2 
Study Calendar 
  
Screening/ 
Baseline 
(-90 days) 
Imaging 
(Day 1) 
Surgery 
(Day 2-
45) 
16 
month 
F/U 
36 
Month 
F/U 
66 
month 
F/U 
16  
year 
F/U 
REQUIRED ASSESSMENTS 
 
 
 
 
 
 
 
Informed Consent 
X 
 
 
 
 
 
 
Inclusion/Exclusion 
X 
 
 
 
 
 
 
Medical History1 
X 
 
 
 
 
 
 
Quality of life Assessments2 
X 
 
 
X 
X 
X 
X 
Surgeon plan (pre-PET) 
X 
 
 
 
 
 
 
PSMA dose and PET scan 
 
X 
 
 
 
 
 
SOC MRI3 
 
X 
 
 
 
 
 
Surgeon plan (post-PET)4 
 
X 
 
 
 
 
 
SOC prostatectomy 
 
 
X 
 
 
 
 
Surgery plan (performed) 
 
 
X 
 
 
 
 
Pathologic assessment of 
whole mount5 
 
 
X 
 
 
 
 
Footnotes: 
1. Medical history may be obtained via medical records, as necessary. 
2. Quality of Life Assessments include the following: 
 
a. IIEF-15 Score (Erectile function) 
b. EPIC-26 Questionnaire (Urinary function) 
c. SF-36 Quality-of-life assessment 
3. If the patient does not already have a recent SOC MRI (within 6 months), it will need to be 
completed as per SOC prior to the PSMA-PET scan. 
4. This should be completed within 9 days of the scan. 
5. The pathologic whole mount assessments may be batch completed per pathology discretion 
6. 1-month follow-up is 4-6weeks.  3-month follow-up is +/-1-month, 6-month and 12-month follow-
up are +/-2-months 

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8.3 
Assessments by Visit 
8.3.1 Baseline/Screening (within 3 months of scan): 
• Informed consent: investigators or their designees will discuss with subjects the 
nature of the study, its requirements, risks, and restrictions to obtain informed 
consent for participation in the study. Subjects should have sufficient time to 
review the study information and consent form and to ask any questions 
necessary to make an informed decision regarding their participation in the study. 
Written informed consent is to be obtained before any other study-specific 
procedure. 
 
• Eligibility criteria: make sure patient meets study eligibility criteria. 
• Medical history: includes past medical history, past surgical history, allergies, any 
ongoing medical conditions, and including medications noted in patients record at 
time of screening.  This can be collected from medical records. 
• Quality of Life Assessments (see study calendar): 
8.3.2 Imaging 
• Eligibility criteria: ensure subject continues to meet study eligibility (if longer than 
60 days since screening) 
• Medical history: capture additional medical history since screening (if longer than 
60 days since screening) 
• Concomitant medications: record medications taken since screening through day 
of surgery (if longer than 60 days since screening) 
• 
68Ga-PSMA-11 PET-CT:   
o Patient receives a ~3-5 mCi dose of 68Ga-PSMA-11. (A physician-
sponsored IND has been successfully obtained) 
o Patient will undergo research Vision PET-CT at Goodman Hall which is 
anticipated to last approximately 60 minutes (or similar scanner).  Per our 
institutional standard of care, patients will receive intravenous iodinated 
contrast with the PET-CT unless medically contraindicated. 
 
 

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Imaging Protocol for 68Ga-PSMA-11 PET Data Acquisition 
Time 
(minutes) 
Activity 
- 60 
Patient arrives, and completes consent forms, while radiopharmaceutical 
synthesis and quality control procedures are completed. 
-5-0 
Dual Energy CT for Attenuation Correction 
0 
Start PET/CT acquisition and administer 68Ga-PSMA-11, 3-5 mCi (inside the 
camera). 
0-60 
Flow motion list-mode acquisition of PET data, allowing reconstruction of 
static images of radiopharmaceutical distribution over various time windows, 
as well as tracer kinetic modeling to determine whether and how regional 
pharmacokinetics are affected by the underlying regional (patho)physiology.   
60-65 
Contrast-CT to assist in prostate segmentation from the PET acquisition for 
fusion to both the mpMRI and the lesion mapping from whole-mount 
pathology. (Contrast CT will be omitted, if contrast agent is contraindicated 
based on standard clinical criteria for contrast administration.) 
65 
Patient can leave camera and depart. 

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o Reconstruction of static images showing the distribution of radioactivity in 
the pelvis in various time windows (e.g., 3-7 minutes; 10-15 minutes; 20-
30 minutes; 40-55 minutes) to examine definition of the location and 
extent of prostate cancer. 
o Input function formation for multi-parametric PET analysis:   The input 
function will be generated by placing a 3D volume-of-interest in left atrium 
/ left ventricle blood pool of the heart.  The input function frame sequence 
will consist of 12x5s followed by 9x10s frames during the peak and a 150 
s frame at 7.5 minutes, a 300 s frames at 15, 30, and 55 minutes.  
 
Alternatively, we will also assess characterization of the input function will 
be generated by placing a 3D volume of interest over the abdominal aorta 
(possibly including the bifurcation) to capture the needed measures of 
blood pool radioactivity.  
o The PET read will be done by a board-certified nuclear medicine 
specialist (e.g. Mark Tann, MD or similar) and the MRI read will be done 
by a board certified MR radiologist (e.g. Jordan Swensson, MD or similar).  
Suspicious lesions will be marked in a blinded fashion. 
o AE assessment: AEs will be assessed at the time of 68Ga-PSMA-11 
administration any event not expected is collected including but not 
limited to: rash and shortness of breath. 
o Safety monitoring following radiopharmaceutical administration will 
consist of visual and verbal monitoring of the patent after injection, and 
during and at the conclusion of the PET/CT procedure, with any apparent 
patient abnormalities, reactions or reported effects noted in the study 
records. 
o The nuclear medicine technologists administering the 
radiopharmaceutical are responsible for immediately reporting any 
adverse or unexpected events to the principal investigator or clinical 
designee, who will report the occurrence of any adverse events to the 
IRB. 
o As in most clinical nuclear medicine procedures, these 
radiopharmaceuticals are administered at a sub-pharmacologic 
doses.  Adverse events are exceedingly unlikely, as 68Ga-HBED-CC has 
been clinically employed, extensively and without reported incident, 
in  clinical patient diagnostic imaging studies in prostate cancer patients in 
Germany and other European countries, as well as in over 400 patients 
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o If there is a discrepancy between the PSMA and conventional MRI scan, 
the investigators will discuss the treatment plan with the patient at the 
investigator’s discretion. This will be completed through a pre-surgery 
clinic or virtual visit within 9days of the PET/CT scan. 
8.3.3 Surgery and Pathology 
• The standard of care surgical procedure is performed as indicated by the cancer. 
• Pathologic assessment: whole mount sections of prostate tissue and routine 
sections of lymph nodes if applicable will be fixed and analyzed by licensed 
pathologist per routine care.  This typically happens within 2 weeks of 
prostatectomy. 
• Additional study-related pathologic assessment: intraprostatic lesion-based 
assessment will be done to document the % Gleason pattern 3, 4, and 5 within 
each lesion.  The Extra-prostatic extension and positive margins will be 
documented.  This may be “batched” at the discretion of the pathology 
department. 
• How the knowledge of the PSMA-PET informs treatment will be tracked. 
Examples of informing the decision include the number and location of 68Ga-
PSMA-PET detected: additional intraprostatic cancer lesions diagnosed, extra-
prostatic extension, seminal vesicle invasion, and lymph node invasion. 
9 
STUDY WITHDRAWAL/DISCONTINUATION 
Subjects must be discontinued from the study for the following reasons: 
• Withdrawal of consent 
• Investigator deems withdrawal necessary at any time if it is determined that it is 
not in the subjects best interest to continue, or if the subject is found to be 
noncompliant with study procedures. 
If subject discontinues after administration of study drug, he or she will be encouraged 
to continue on study for safety procedures per protocol. Reason(s) for discontinuing 
must be clearly documented in the appropriate source documents. 
10 
STATISTICAL CONSIDERATIONS 
10.1 
Study Design 
A prospective, single arm, pilot study for evaluating the performance of PSMA-PET 

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10.2 
Study Population 
The enrolled population comprises all patients who meet the eligibility criteria and are 
registered onto the study. 
10.3 
Sample Size 
The sample size justification of the pilot study is based on the primary objective of estimating 
the sensitivity and specificity for PSMA-PET for detecting extra-prostatic extension of cancer at 
the nerve bundles. The sensitivity and specificity will be calculated using both the left and right 
nerve bundles, based on the gold standard of whole-mount pathology.  A sample size of 50 
patients would therefore generate 100 data points. Assuming about 20% of the 100 left and right 
nerve bundles are not evaluable. Then we could have at least 80 data points.  
Based on the preliminary data, the prevalence of extra-prostatic extension is about 35%. The 
sensitivity of PSMA-PET is anticipated to be 90%. A sample size of 80 would provide a two-
sided 95% sensitivity confidence interval with a width of at most 0.23. The specificity of PSMA-
PET is anticipated to be 76%. A sample size of 80 would provide a two-sided 95% specificity  
confidence interval with a width of at most 0.25. All calculations will be based on the simple 
asymptotic method with continuity correction. 
10.4 
Participant Characteristics 
Demographic characteristics will be summarized using descriptive statistics. 
10.5 
Analysis of Primary Objective 
The sensitivity and specificity will be summarized along with 95% CI using the simple 
asymptotic method with continuity correction. PPV and NPV will also be summarized along 
with 95% CI using the simple asymptotic method with continuity correction. 
10.6 
Analysis of Secondary Objectives 
 
The frequency of proper treatment changes directed by PSMA-PET compared to MRI 
will be summarized along 95% CI for all evaluable subjects, and separated for 3 areas 
important for genito-urinary function including: 1) Bladder neck, 2) Nerve bundles, 3) 
Urethral Sphincter (Figure 4).  We will use the McNemar test to compare the sensitivity and 
specificity values between PET and MRI although data from this pilot study is considered 
hypothesis generating only due to the small sample size. 
 
The quality of life data including IIEF-15 (Erectile function score), EPIC-26 (Pad use), SF-36 
(overall mental and physical health domains) are longitudinal data, which will be analyzed 
separately. The analysis will start with the graphical representation of the data, where 

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mean and the standard of mean at each time point will be plotted and linked over time. 
An exploratory statistical modelling approach will be conducted to analyze the change 
over time. In particular, a mixed effects model will be used to analyze the data.  
 
The parametric kinetic modeling data will be assessed for goodness-of-fit of the measured 
regional tissue time-activity curves to the applied kinetic model. Additionally, the images derived 
by voxel-wise kinetic modeling will be visually compared to standard reconstructions of the 
integrated regional concentration of radioactivity, assessing apparent lesion size, lesion 
position, and lesion/background contrast.  
11 
DATA FORMS AND SUBMISSION SCHEDULE 
This study will utilize the secure, web-based, Research Electronic Data Capture 
(REDCap) system for data input.  REDCap was developed by Vanderbilt University and 
is provided by Indiana University through their community license.  REDCap is 
managed by the Indiana University Department of Biostatistics and secured by 
University Information Technology Services Advanced IT Core.  Access to the password 
protected database will be limited to the investigators of this study, and any data that is 
distributed will be either de-identified or authorized by written permission from the 
subject. 
All source documents are to remain in the patient’s clinic file.  All documents should be 
kept according to applicable federal guidelines.  
12 
DATA AND SAFETY MONITORING PLAN 
This study will be conducted in accordance with the IU Simon Cancer Center 
Institutional DSMP for High Risk Trials.    
  
Investigators will conduct continuous review of data and subject safety. Weekly review 
meetings for high risk trials are required and will include the principal investigator, 
clinical research specialist and/or research nurse (other members per principal 
investigator’s discretion). Weekly meeting summaries should include review of data and 
subject safety by including for each dose level: the number of subjects, significant 
toxicities as described in the protocol, dose adjustments and responses observed. 
Study teams should maintain meeting minutes and attendance for submission to the 
DSMC upon request.    
Data and Safety Monitoring Committee  
The IUSCC Data and Safety Monitoring Committee (DSMC) is responsible for oversight 
of subject safety, regulatory compliance, and data integrity for this trial.  The DSMC will 

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review this study semi-annually to review overall trial progress, toxicity, compliance, 
data integrity, and accrual per the Institutional DSMP.    
  
Furthermore, the DSMC conducts an administrative review of serious adverse events 
(SAEs), deviations, reportable events, and any other outstanding business.  Major 
issues may require further DSMC review or action.    
  
For any increase in frequency of grade 3 or above adverse events (above the rate 
reported in the Investigator Brochure or package insert), the principal investigator will 
notify the DSMC Chair immediately.  The notification will include the incidence of study 
adverse events, grades, and attributions, as well as investigator statements regarding 
comparison with risks per the IB/ package insert.     
  
At any time during the conduct of the trial, if it is the opinion of the investigators that the 
risks (or benefits) to the subject warrant early closure of the study, the DSMC Chair and 
Compliance Officer must be notified within 1 business day via email, and the IRB must 
be notified within 5 business days. Alternatively, the DSMC may initiate suspension or 
early closure of the study based on its review. 
12.1 
IND Annual Reports 
For trials with an IND held locally by the IU principal investigator or university, the IND 
Annual Report will be prepared and submitted to the Compliance Team.  This report will 
be reviewed by the DSMC at the time of FDA submission.  
 
12.2 
Study Auditing and Monitoring  
All trials conducted at the IUSCC are subject to auditing/monitoring. Reports will be 
forwarded to the DSMC for review.  
12.3 
Data Management/OnCore Reporting Requirements   
The DSMC reviews data and study progress directly from Oncore; therefore, timely data 
entry and status updates are vital.  Study data must be entered within Oncore promptly, 
no later than one week from study visit occurrence.  Subject status in Oncore will be 

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updated in real time, as this may affect overall trial enrollment status.  Global SAEs and 
deviations will be reviewed on a monthly basis by the DSMC Chair directly from Oncore.    
12.4 
OnCore Safety Reporting  
In addition to protocol- and regulatory-required safety reporting, all serious adverse 
events (SAEs) will be captured in the Oncore system within 1 business day of 
notification.  Initial SAE reporting will include as much detail as available, with follow-up 
to provide complete information.   
Attributions will be assessed to study drugs, procedures, study disease, and other 
alternate etiology.      
12.5 
Study Accrual Oversight  
Accrual data will be entered into the IU Simon Cancer Center OnCore system. The 
Protocol Progress Committee (PPC) reviews study accrual twice per year while the PPC 
coordinator reviews accrual quarterly. 
12.6 
Protocol Deviation Reporting  
Protocol deviations will be entered into OnCore within 5 days of discovery and reviewed 
by the DSMC Chair on a monthly basis. Findings will be reported to the full DSMC at the 
time of study review.  For serious or repetitive protocol deviations, additional action may 
be required by the DSMC.   
13 
ADVERSE EVENTS 
13.1 
Definitions of Adverse Events 
13.1.1 Adverse Event 
An adverse event (AE) is defined as any untoward medical occurrence associated with 
the use of a drug in humans, whether or not considered drug related. An adverse event 
can be any unfavorable and unintended sign (e.g. an abnormal laboratory finding), 
symptom, or disease temporarily associated with the use of a drug, without any 
judgment about causality.  Adverse events will be graded according to the NCI Common 
Toxicity Criteria, Version 4.0 (Appendix A). 

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13.1.2 Serious Adverse Event (SAE) 
A serious adverse event is any untoward medical occurrence resulting in one or more of 
the following: 
• Results in death or ANY death occurring within 28 days of last dose of study drug 
(even if it is not felt to be drug related)  
• Is life-threatening (defined as an event in which the patient was at risk of death at 
the time of the event; it does not refer to an event which hypothetically might 
have caused death if it were more severe) 
• Requires inpatient hospitalization or prolongation of existing hospitalization 
NOTE: Hospitalizations that are not considered SAEs are:  
o Hospitalization planned prior to first administration of study drug 
o Hospitalization for elective treatment of a pre-existing condition unrelated to 
the study medication 
• Results in persistent or significant disability/incapacity 
• Is a congenital anomaly or birth defect 
• Is an important medical event (defined as a medical event(s) that may not be 
immediately life-threatening or result in death or hospitalization but, based upon 
appropriate medical and scientific judgment, may jeopardize the patient or may 
require intervention (e.g., medical, surgical) to prevent one of the other serious 
outcomes listed in the definition above).  Examples of such events include, but 
are not limited to, intensive treatment in an emergency room or at home for 
allergic bronchospasm; blood dyscrasias or convulsions not resulting in 
hospitalization; or the development of drug dependency or drug abuse. 
13.1.3 Unexpected Adverse Event 
An adverse event not mentioned in the Investigator's Brochure or package insert or the 
specificity or severity of which is not consistent with the Investigator's brochure or 
package insert. 
13.1.4 Determining Attribution to the Investigational Agent(s) 
Attribution: An assessment of the relationship between the AE and the medical 
intervention. CTCAE does not define an AE as necessarily “caused by a therapeutic 
intervention”. After naming and grading the event, the clinical investigator must assign 
an attribution to the AE using the following attribution categories: 
Relationship 
Attribution 
Description 

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Unrelated to 
investigational 
agent/intervention 
Unrelated 
The AE is clearly NOT 
related 
Unlikely 
The AE is doubtfully 
related 
Related to investigational 
agent/intervention 
Possible 
The AE may be related 
Probable 
The AE is likely related 
Definite 
The AE is clearly related 
13.2 
Adverse Event Reporting Requirements: 
Adverse events will be recorded for the study drug administration) regardless of whether 
or not the event(s) are considered related to trial medications. All AEs considered 
related to trial medication will be followed until resolution, return to baseline, or deemed 
clinically insignificant, even if this occurs post-trial. 
13.2.1 Reporting to the IRB:  
Unanticipated problems involving risks to subjects or others will be reported promptly 
to the IRB if they:  
• unexpected; 
• related or possibly related to participation in the research; and 
• suggest that the research places subjects or others at a greater risk of harm 
than was previously known or recognized.   
If the serious adverse event does not meet all three (3) criteria listed above, the event 
does not have to be promptly reported to the IU IRB.  However, it should be reported at 
the time of continuing review. 
Prompt reporting of unanticipated problems to the IRB is defined as within 5 days from 
becoming aware of the event. 
13.2.2 Reporting to the IUSCC Data Safety Monitoring Committee: 
Regardless of study sponsorship, the study team must enter all initial and follow-up 
SAE, expedited, and noncompliance reports into OnCore® for review by the DSMC chair 
and/or coordinator. Expedited reports may include IRB Prompt Report Forms, AdEERS 
reports, MedWatch, and additional SAE forms as required by the sponsor. When follow-
up information is received, a follow-up report should also be created in OnCore®. This 
DSMC reporting requirement is in addition to any other regulatory bodies to be notified 
(i.e. IRB, FDA, pharmaceutical company, etc.). The DSMC chair and/or coordinator will 
review all SAE, expedited, and noncompliance reports monthly. 

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14 
 PATIENT CONSENT AND PEER JUDGEMENT 
The protocol and informed consent form for this study must be approved in writing by the 
appropriate IRB prior to any patient being registered on this study.   
Changes to the protocol, as well as a change of principal investigator, must also be 
approved by the Board.  Records of the Institutional Review Board review and approval 
of all documents pertaining to this study must be kept on file by the investigator and are 
subject to inspection at any time during the study.  Periodic status reports must be 
submitted to the Institutional Review Board at least yearly, as well as notification of 
completion of the study and a final report within 3 months of study completion or 
termination.   
The study will be conducted in compliance with ICH guidelines and with all applicable 
federal (including 21 CFR parts 56 & 50), state or local laws. 
15 
REFERENCES 
Bahler, C. D., Green, M., Hutchins, G. D., Cheng, L., Magers, M. J., Fletcher, J., & 
Koch, M. O. (2019). PSMA-Targeted Positron Emission Tomography (PET) in 
Evaluation of Patients with Primary Prostate Cancer: Comparison of Pre-operative 
[68Ga]Ga-PSMA-11 PET/CT, Immediate Post-operative Specimen [68Ga]Ga-PSMA-
11 Imaging, and Whole Mount Pathology. The Journal of Urology, 
101097JU0000000000000501. http://doi.org/10.1097/JU.0000000000000501 
 
Baunacke, M., Schmidt, M.-L., Groeben, C., Borkowetz, A., Thomas, C., Koch, R., et al. 
(2020). Decision Regret after Radical Prostatectomy does Not Depend on Surgical 
Approach: 6-Year Followup of a Large German Cohort Undergoing Routine Care. 
The Journal of Urology, 203(3), 554–561. 
http://doi.org/10.1097/JU.0000000000000541 
 
Berger, I., Annabattula, C., Lewis, J., Shetty, D. V., Kam, J., Maclean, F., et al. (2018). 
68Ga-PSMA PET/CT vs. mpMRI for locoregional prostate cancer staging: correlation 
with final histopathology. Prostate Cancer and Prostatic Diseases, 21(2), 204–211. 
http://doi.org/10.1038/s41391-018-0048-7 
Borofsky, S., George, A. K., Gaur, S., Bernardo, M., Greer, M. D., Mertan, F. V., et al. 
(2017). What Are We Missing? False-Negative Cancers at Multiparametric MR 
Imaging of the Prostate. Radiology, 152877–10.  

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Emmett, L., & Hofman, M. S. (2020). Editorial Comment. The Journal of Urology, 
203(1), 99–99. http://doi.org/10.1097/01.JU.0000605568.03568.2c 
Sonn, G. A., Fan, R. E., Ghanouni, P., Wang, N. N., Brooks, J. D., Loening, A. M., et al. 
(2017). Prostate Magnetic Resonance Imaging Interpretation Varies Substantially 
Across Radiologists. European Urology Focus, 1–8. 
http://doi.org/10.1016/j.euf.2017.11.010 
 
Fendler WP, Eiber M, Beheshti M, Bomanji J, Ceci F, Cho S, Giesel F, Haberkorn U, 
Hope TA, Kopka K, Krause BJ, Mottaghy FM, Schoder H, Sunderland J, Wan S, 
Wester HJ, Fanti S, Herrmann K. 68Ga-PSMA PET/CT: Joint EANM and SNMMI 
procedure guideline for prostate cancer imaging: version 1.0. Eur J Nucl Med Mol 
Imaging.  2017. 
 
Green MA, Eitel JA, Fletcher JW, Mathias CJ, Tann MA, Gardner T, Koch MO, Territo 
W, Polson H, Hutchins GD. Estimation of radiation dosimetry for 68Ga-HBED-CC 
(PSMA-11) in patients with suspected recurrence of prostate cancer. Nucl Med Biol. 
46:32-35; 2017.  doi: 10.1016/j.nucmedbio.2016.11.002. PubMed PMID: 28012435. 
 
Hu, J. C., Chang, E., Natarajan, S., Margolis, D. J., Macairan, M., Lieu, P., et al. (2014). 
Targeted Prostate Biopsy to Select Men for Active Surveillance: Do the Epstein 
Criteria Still Apply? Juro, 192(2), 385–390. http://doi.org/10.1016/j.juro.2014.02.005 
 
Le, J. D., Tan, N., Shkolyar, E., Lu, D. Y., Kwan, L., Marks, L. S., et al. (2015). 
Multifocality and Prostate Cancer Detection by Multiparametric Magnetic Resonance 
Imaging: Correlation with Whole-mount Histopathology. European Urology, 67(3), 
569–576. http://doi.org/10.1016/j.eururo.2014.08.079 
 
Sonn, G. A., Fan, R. E., Ghanouni, P., Wang, N. N., Brooks, J. D., Loening, A. M., et al. 
(2017). Prostate Magnetic Resonance Imaging Interpretation Varies Substantially 
Across Radiologists. European Urology Focus, 1–8. 
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van Stam, M.-A., Aaronson, N. K., Bosch, J. L. H. R., Kieffer, J. M., van der Voort van 
Zyp, J. R. N., Tillier, C. N., et al. (2020). Patient-reported Outcomes Following 
Treatment of Localised Prostate Cancer and Their Association with Regret About 
Treatment Choices. European Urology Oncology, 3(1), 21–31. 
http://doi.org/10.1016/j.euo.2018.12.004 
 
 
 
 
 

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16 
APPENDICES 
16.1 
Appendix A 
NCI Common Toxicity Criteria (Version 4.0) 
Due to the size of the latest version of the Common Toxicity Criteria, copies of this 
appendix are not included with this protocol document. 
An electronic copy is available on the CTEP web site, 
http://ctep.cancer.gov/reporting/ctc.html