Increasing the Dose of Survivorship Care Planning in Prostate Cancer Survivors Who Receive Androgen Deprivation Therapy
Phase: NA
Conditions: Prostate Adenocarcinoma
Sponsor: NRG Oncology

NRG ONCOLOGY 
 
NRG-CC007CD 
(ClinicalTrials.gov NCT #NCT03860961) 
 
INCREASING THE DOSE OF SURVIVORSHIP CARE 
PLANNING IN PROSTATE CANCER SURVIVORS WHO 
RECEIVE ANDROGEN DEPRIVATION THERAPY 
 
Amendment 4 March 24, 2021 

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NRG ONCOLOGY 
NRG-CC007CD 
(ClinicalTrials.gov NCT #NCT03860961) 
 
INCREASING THE DOSE OF SURVIVORSHIP CARE PLANNING IN PROSTATE 
CANCER SURVIVORS WHO RECEIVE ANDROGEN DEPRIVATION THERAPY 
 
This trial is sponsored by the National Cancer Institute (NCI), will be led by NRG Oncology and 
is open to all affiliated NCORP components and subcomponents (Alliance for Clinical Trials 
in Oncology, ECOG-ACRIN Cancer Research Group, NRG Oncology, and SWOG). 
Coordinating Center 
NRG Oncology 
Four Penn Center, 1600 JFK Blvd., Suite 1020 
Philadelphia, PA 19103 
 
Study Team (24-Mar-2021) 
Principal Investigator  
Ronald Chen, MD, MPH 
University of Kansas 
Department of Radiation Oncology 
4001 Rainbow Blvd. MS 4033 
Kansas City, KS 66160 
Phone: 913-588-3612 
Fax: 913-588-3663 
rchen2@kumc.edu 
 
Study Co-Chair 
Patricia Ganz, MD 
Jonsson Comprehensive Cancer Center, UCLA 
650 Charles Young Drive - South 
Room A2-125 CHS Box 956900-6900 
Los Angeles, CA 90095 
Phone/Fax310-206-1404/310-206-3566  
pganz@mednet.ucla.edu 
 
Statistician 
Stephanie Pugh, PhD 
NRG Oncology 
50 South 16th Street, Suite 2800 
Philadelphia, PA 19102 
Phone: 215-717-0850/Fax: 215-928-0153 
Email: pughs@nrgoncology.org 
 
 
 
 
 
 
 
Study Co-Chair 
Gilbert D. A. Padula, MD 
University Hospitals Seidman Cancer Center 
and Case Western Reserve University 
School of Medicine 
11100 Euclid Avenue  
Cleveland, Ohio 44106 
Phone: 216-844-2558/Fax: 216-201-5179 
Gilbert.Padula@UHhospitals.org 
 
Study Co-Chair 
Bridget Koontz, MD 
Duke Cancer Institute 
Radiation Oncology Department 
30 Medicine Circle, Room 05151, Box 3085 
Durham, NC 
Phone/Fax: 919-668-5213/919-668-7345  
bridget.koontz@duke.edu 
 
Study Co-Chair, Health Disparities 
Kate A. Yeager, PhD, RN 
Emory University Hospital/Winship Cancer 
Institute  
1520 Clifton Road, Room 228    
Atlanta, GA 
Phone: 404-727-8627/Fax: 404-727-9382 
kyeager@emory.edu 

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Protocol Coordinator 
For questions concerning protocol and informed 
consent versions & amendments 
Erica Field 
NRG Oncology 
50 South 16th Street, Suite 2800 
Philadelphia, PA 19102 
Phone: 215-940-8824/Fax: 215-574-0300 
Email: fielde@nrgoncology.org 
 
NCORP Committee Principal Investigators 
Deborah Bruner, PhD, RN 
Joan L. Walker, MD 
 
Data Management 
For questions concerning eligibility and 
data submission 
Apsara Nair 
NRG Oncology  
50 South 16th Street, Suite 2800 
Philadelphia, PA 19102 
Phone: 215-717-0858 
Email: naira@nrgoncology.org 
 
Cancer Care Delivery Committee Co-
Chairs 
Mary Cooley, PhD, RN 
Matthew Hudson, PhD, MPH 
 
The following Group Study Champion has been added to this trial: 
SWOG 
Peter Van Veldhuizen, MD 
University of Rochester 
601 Elmwood Avenue, Box 704 
Rochester, NY 14642 
Phone: 585-275-0394 
Email: Peter_Vanveldhuizen@urmc.rochester.edu 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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NRG ONCOLOGY 
NRG-CC007CD 
INCREASING THE DOSE OF SURVIVORSHIP CARE PLANNING IN PROSTATE 
CANCER SURVIVORS WHO RECEIVE ANDROGEN DEPRIVATION THERAPY 
 
Participating Sites 
☒ U.S. (NCORP practices only) 
☐ Canada 
☐ Approved International Member Sites 
 
 
 
Document History 
 
Version Date 
Amendment 4 
March 24, 2021 
Amendment 3 
October 20, 2020 
Amendment 2 
November 6, 2019 
Amendment 1 
October 4, 2019 
Initial 
January 24, 2019 
 
 
 
 
This protocol was designed and developed by NRG Oncology.  It is intended to be used 
only in conjunction with institution-specific IRB approval for study entry.  No other use 
or reproduction is authorized by NRG Oncology nor does NRG Oncology assume any 
responsibility for unauthorized use of this protocol. 
 
 

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CANCER TRIALS SUPPORT UNIT (CTSU) ADDRESS AND CONTACT 
INFORMATION (24-Mar-2021)  
For regulatory requirements: 
For participant 
enrollments: 
For study data submission: 
Regulatory documentation must 
be submitted to the CTSU via the 
Regulatory Submission Portal: 
Regulatory Submission Portal 
(Sign in at www.ctsu.org, and 
select the Regulatory > 
Regulatory Submission.) 
Institutions with participants 
waiting that are unable to use the 
Portal should alert the CTSU 
Regulatory Office immediately 
at 1-866-651-2878 to receive 
further instruction and support. 
Contact the CTSU Regulatory 
Help Desk at 1-866-651-2878 for 
regulatory assistance. 
Refer to the participant 
enrollment section of the 
protocol for instructions 
on using the Oncology 
Patient Enrollment 
Network (OPEN), which 
can be accessed at 
https://www.ctsu.org/ 
OPEN_SYSTEM/ or 
https://OPEN.ctsu.org. 
 
Contact the CTSU Help 
Desk with any OPEN-
related questions at 
ctsucontact@westat.com. 
Data collection for this study 
will be done exclusively 
through Medidata Rave.  
Please see the data 
submission section of the 
protocol for further 
instructions.  
 
 
Do not submit study data or 
forms to CTSU Data 
Operations.  Do not copy the 
CTSU on data submissions. 
The most current version of the study protocol and all supporting documents must be 
downloaded from the protocol-specific Web page of the CTSU Members' website 
(https://www.ctsu.org).  Access to the CTSU Members' website is managed through the 
Cancer Therapy and Evaluation Program - Identity and Access Management (CTEP-IAM) 
registration system and requires user log on with CTEP-IAM username and password. 
For clinical questions (i.e., participant eligibility or study procedure related questions), 
contact the Clinical Data Coordinator for NRG-CC007CD by phone (215-574-4164) or email 
(smallt@nrgoncology.org) 
For non-clinical questions (i.e., unrelated to participant eligibility, treatment, or clinical 
data submission), contact the CTSU Help Desk by phone or email: 
CTSU General Information Line – 1-888-823-5923 or ctsucontact@westat.com.  All calls and 
correspondence will be triaged to the appropriate CTSU representative. 
 
 

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TABLE OF CONTENTS 
NRG ONCOLOGY..................................................................................................................................... 1 
TABLE OF CONTENTS ............................................................................................................................ 5 
NRG-CC007CD SCHEMA ........................................................................................................................ 7 
1. 
OBJECTIVES ................................................................................................................................ 9 
1.1 
Primary Objective .......................................................................................................... 9 
1.2 
Secondary Objectives..................................................................................................... 9 
1.3 
Exploratory Objectives .................................................................................................. 9 
2.  
BACKGROUND ........................................................................................................................... 9 
3. 
PARTICIPANT ELIGIBILITY AND INELIGIBILITY CRITERIA .......................................... 11 
3.1 
Practice Eligibility Criteria  ......................................................................................... 11 
3.2  
Guidelines for Screening .............................................................................................. 12 
3.3 
Patient Eligibility Criteria ............................................................................................ 13 
3.4 
Ineligibility Criteria ..................................................................................................... 13 
4. 
STUDY REQUIREMENTS......................................................................................................... 13 
5. 
STUDY PROCEDURES ............................................................................................................. 15 
6. 
TREATMENT MODIFICATIONS/MANAGEMENT ................................................................ 16 
7. 
ADVERSE EVENTS REPORTING REQUIREMENTS ............................................................ 16 
8. 
REGISTRATION AND STUDY ENTRY PROCEDURES ........................................................ 17 
8.1 
CTEP Registration Procedures and Access requirements for OPEN, Medidata Rave .. 17 
8.2 
Practice Randomization Assignment............................................................................ 18 
8.3 
Site Registration Requirements .................................................................................... 19 
8.4 
Patient Enrollment ....................................................................................................... 21 
8.5 
Medidata Patient Cloud ePRO Registration ................................................................. 22 
9. 
DRUG INFORMATION ............................................................................................................. 23 
10.  
PATHOLOGY/BIOSPECIMEN .................................................................................................. 23 
11.  
SPECIAL STUDIES (NON-TISSUE) ......................................................................................... 23 
11.1 
Adherence to AHA guideline recommendations .......................................................... 23 
11.2 
Cardiovascular disease (CVD) risk score ..................................................................... 23 
11.3 
Patient-reported outcomes............................................................................................ 24 
12.  
DATA MANAGEMENT/COLLECTION ................................................................................... 25 
12.1 
Summary of Data Submission ...................................................................................... 25 
12.2 
Quality Portal ............................................................................................................... 26 
12.3 
Global Reporting/Monitoring....................................................................................... 26 
13. 
STATISTICAL CONSIDERATIONS ......................................................................................... 26 
13.1 
Study Design ................................................................................................................ 26 
13.2 
Study Endpoints ........................................................................................................... 26 
13.3 
Primary objectives and study design ............................................................................ 27 
13.4 
Study Monitoring of the Primary Objective ................................................................. 29 
13.5 
Accrual Considerations ................................................................................................ 29 
13.6 
Secondary Endpoints  .................................................................................................. 29 
13.7 
Exploratory Endpoints ................................................................................................. 32 
13.8 
Gender/Ethnicity/Race Distribution ............................................................................. 32 

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REFERENCES ......................................................................................................................................... 34 
APPENDIX A: ARM A STUDY REQUIREMENTS .............................................................................. 37 
APPENDIX B: ARM B STUDY REQUIREMENTS ............................................................................... 38 
APPENDIX C: SURVIVORSHIP CARE PLAN (SCP)  .......................................................................... 39 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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NRG-CC007CD SCHEMA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Survivorship Care Plan (SCP)* 
• Review with patient and send to 
Primary Care Provider (PCP) 
during last week of RT (described 
further in Appendix A which is 
provided only at randomization):  
 
Survivorship Care Plan (SCP)** 
• Review with patient and send to PCP during 
last week of RT (further details in 
Appendix B which is provided only at 
randomization)  
Arm A (Standard Arm) 
Arm B (Enhanced Survivorship Care Plan) 
Prostate cancer patients who receive radiation therapy 
(RT) and androgen deprivation therapy (ADT) 
Randomize by Practice 
Treatment Plan (TP)*  
Review with patient and send to Primary Care 
Provider (PCP) at study enrollment (beginning 
of radiation treatment) 

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Patient Screening and Enrollment Process (04-Oct-2019) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Please refer to Section 3.1  for more information concerning how a practice is defined and Section 8 for 
the enrollment process. Each practice will be provided with arm-specific instructions and assessments 
after randomization. 
 
*Treatment Plan (TP): Will be provided at beginning of radiation treatment. The TP will be provided to 
each practice randomized to Arm B. The TP will be provided to sites randomized to Arm B only.  
 
**Survivorship care plan (SCP): Provided during the last week of radiation therapy. Includes all 
information in Treatment Plan (TP), and summarizes treatment received/is receiving.  
 
 
 
 
 
 
 
 
 
 
Step 0: Screen prostate cancer patients who are to receive radiation therapy and 
androgen deprivation therapy 
Data entered on Step 0: Screening 
1. Does the patient meet all eligibility criteria except the PCP 
requirement?  Y/N 
2. Does the patient have a PCP or cardiologist? Y/N 
3. Is the patient going on study? Y/N  
Step 0: Screening 
• 
YES – patient is 
eligible except PCP 
requirement 
• 
YES – patient has a 
PCP or cardiologist 
• 
YES – patient is going 
on study 
Proceed to Step 1: 
Registration 
Step 0: Screening 
• 
YES – patient is eligible except 
PCP requirement 
• 
YES – patient has a PCP or 
cardiologist 
• 
NO – patient is not planning on 
going on study  
Complete reason for not going on 
study and do not proceed to Step 1: 
Registration 
Step 0: Screening 
• 
YES – patient is eligible 
except PCP requirement 
• 
NO – patient doesn’t have 
PCP or cardiologist 
• 
NO – patient is not 
planning on going on study 
Complete reason for not going on 
study and do not proceed to Step 
1: Registration 

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1. OBJECTIVES 
1.1 
Primary Objective 
1.1.1 To determine if the experimental arm (increased doses of SCP) has more patients who 
saw a primary care provider and had blood glucose and cholesterol checked in Year 2 
(13-24 months) after finishing RT as compared to the control arm. 
 
1.2 
Secondary Objectives 
1.2.1 To determine if patients who receive increased doses of SCP have lower cardiovascular 
disease (CVD) risk score at 2 years as compared to patients who receive a one-time SCP. 
1.2.2 To determine if patients who receive increased doses of SCP have improved patient 
reported coordination and satisfaction with care with respect to their PCP or cardiologist 
as compared to patients who receive a one-time SCP and whether health literacy modifies 
the effect of SCP use on patient-reported coordination of care and satisfaction with care 
with respect to their PCP or cardiologist. 
1.2.3 To determine the number of patients eligible, but without a PCP/cardiologist. 
1.2.4 To describe the current practice related to SCP delivery and prostate cancer survivor 
monitoring in participating NCORP practices. 
 
1.3 
Exploratory Objectives 
1.3.1 To determine if patients who receive increased doses of SCP have improved patient 
reported coordination and satisfaction with care with respect to their cancer specialist as 
compared to patients who receive a one-time SCP and whether health literacy modifies 
the effect of SCP use on patient-reported coordination of care and satisfaction with care 
with respect to their cancer specialist. 
 
2.  BACKGROUND (20-OCT-2020) 
Practitioners are increasingly aware of coordinated health care’s importance in cancer 
survivorship. The 2013 Institute of Medicine report “Delivering High-Quality Cancer Care: 
Charting a New Course for a System in Crisis," (IOM 2013) specifically highlights a need for 
coordinated care between the cancer care team with the primary care team. This is especially 
relevant for prostate cancer survivors who receive androgen deprivation therapy (ADT) in 
conjunction with radiation therapy (RT). These prostate cancer survivors need routine 
oncologic follow-up with their radiation oncologist and also coordinated routine follow-up 
with their primary care provider (PCP). The latter is particularly important because ADT 
heightens a patient’s risk for developing diabetes, hypercholesterolemia, and cardiovascular 
events.  
 
A joint publication from the American Heart Association, American Cancer Society and 
American Urological Association made specific recommendations regarding cardiovascular 
follow-up for prostate cancer patients who receive ADT (Levine, 2010): 
• ADT’s metabolic effects warrant PCP referral for periodic follow-up evaluation. This 
evaluation should include assessments of blood pressure, lipid profile, and blood glucose 
level. Since some of the effects of ADT occur within 3 months of treatment, initial 
evaluation should occur within 3-6 months after starting ADT; 
• Blood glucose and lipids should be checked at least yearly; 

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• The referring physician (i.e. cancer specialist) should provide PCPs information on 
ADT’s potential side effects, including glucose intolerance and dyslipidemia. 
Currently, practitioners lack evidence regarding the best way to improve coordination of 
follow-up care for prostate cancer survivors so that they receive the necessary cardiovascular 
follow-up care. Survivorship Care Plan (SCP), initially described by the Institute of Medicine 
(Hewitt, Greenfield and Tovall, 2006), is a tool developed to facilitate care coordination for 
cancer survivors. The SCP documents a summary of the patient’s cancer diagnosis, 
treatment(s) received, and follow-up care recommendations. For this trial, radiation 
oncologists will create SCPs and specifically include information about ADT and 
recommended cardiovascular follow-up care; both the patient and his primary care provide 
will receive the SCP. 
 
While SCPs have face validity there is little evidence clarifying whether or how SCPs 
improve patient care and patient outcomes. There are 5 published randomized trials 
comparing routine care without SCP vs. the provision of a one-time SCP document (see 
Figure 1).  
 
Figure 1: Comparison of randomized trials with and without SCP 
 
Patient 
Population 
Study Findings 
Grunfeld 2011; 
Boekhout 2015 
Breast 
No difference in patient-reported outcomes or 
adherence to breast cancer surveillance 
Hershman 2013 
Breast 
No difference in patient-reported outcomes 
Brothers 2013 
Gynecologic 
No difference in patient-perceived quality of 
care 
Nicolaije 2015 
Endometrial 
No difference in patient-reported satisfaction 
with information or care 
Maly 2017 
Breast 
SCP improved physician breast cancer follow-
up care in Latina breast cancer patients 
 
Four of these first-generation SCP trials showed no improvement in any measured outcome 
suggesting a single “dose” of SCP to patients fails to exert a demonstrable effect on survivor 
outcomes. A more recent trial demonstrated a benefit in care received by Latina breast cancer 
patients (Maly et al. 2017).  Recently observed impact notwithstanding, the predominant null 
findings indicate a strong need for further studies specifically addressing the optimization of 
SCPs use in order to improve patient outcomes. This study addresses this need by examining 
whether increasing the dose of survivorship care planning improves patient care and 
outcomes. 
 
Specifically we hypothesize that patients whose primary care providers receive an initial 
treatment plan, and subsequently receive the increased doses of SCP post-treatment (all of 
which describe the potential risks of ADT and need for primary care follow-up and 
monitoring) will demonstrate improved care as measured by completion of the recommended 
cardiovascular follow-up. The secondary objectives address lower CVD risk scores and 
patient-reported outcomes including coordination of and satisfaction with care. We 

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hypothesize that increased dose of SCP will improve patients’ perception of coordination of 
and satisfaction with care compared to the standard arm.  Additionally one factor that may 
modify the patient outcomes is health literacy.  Health literacy is the degree to which 
individuals have the capacity to obtain, process, and understand basic health information and 
services needed to make appropriate health decisions (Ratzan & Parker 2000).  Inadequate 
health literacy has been associated with lower patient satisfaction and lower preventive 
service compliance (MacLead et al, 2017).  In this trial, we will assess each patient’s health 
literacy to see if literacy is a modifier of the primary and secondary trial outcomes. 
 
Description of study 
The present study will specifically evaluate whether increasing the “dose” of survivorship 
care planning (SCP) improves care and outcomes in prostate cancer patients receiving RT 
plus ADT. The impact of increasing the dose of survivorship care on patient care and 
outcomes, including adherence to AHA guidelines, control of cardiovascular disease (CVD) 
risk factors, and coordination of and patient satisfaction with care will be compared with that 
of standard care (i.e., a one-time provision of the SCP to patients).      
 
This is a cluster-randomized trial in which 35 practices (defined in Section 3.1) will be 
randomized to receive standard of care (single post-treatment SCP) or experimental care 
(increased dose of SCP).  All patients will be screened for potential eligibility in the study 
from all participating practices regardless of treatment arm.  Completion of study specific 
training will be required prior to trial participation with additional details provided in Section 
8.3.  More information regarding the screening portion of the trial can be found in Section 
3.2 and information regarding practices and registration procedures can be found in Section 
8. 
      
3. PARTICIPANT ELIGIBILITY AND INELIGIBILITY CRITERIA 
Per NCI guidelines, exceptions to inclusion and exclusion criteria are not permitted.  
For questions concerning eligibility, please contact the Biostatistical/Data Management 
Center (see protocol cover page). 
 
3.1 
Practice Eligibility Criteria (20-Oct-2020) 
Practices (defined as a single NCORP component or subcomponent; or NCORP 
component and/or subcomponents that share the same physicians and/or staff, but are in 
different locations) will be randomized to receive standard of care (control arm) or 
increased SCP dose (experimental arm) once all of the eligibility criteria specified below 
have been met.  
 
3.1.1 All institutions participating in a practice are NCORP components or sub-components. 
3.1.2 Have a mechanism for delivering SCPs to prostate cancer patients. Practices that 
currently provide SCPs are eligible but for this trial will need to use the study-provided 
SCP template (Appendix C).  
3.1.3 See at least 10 patients meeting eligibility criteria per year  
3.1.4 Completion and submission of the NRG-CC007CD Letter of Intent (LOI) (posted on the 
CTSU website) by each practice to nrg-cc007CD@nrgoncology.org).  

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3.1.5 IRB approval 
3.1.6 Each PI and RA at a NCORP practice must complete NRG-CC007CD SCP training. A 
training certificate will need to be completed and uploaded to the CTSU Regulatory 
Submission Portal. (See NRG-CC007CD Training Memo and Slides; located on the 
CTSU website). Note: staff and physicians cannot be part of multiple practices. 
3.1.7 For a practice that is participating on Wake Forest study, WF-1804CD is not able to 
participate in this trial in order to not impact the fidelity of either trial. As long as the 
clinicians (physicians, APPs) are different for the patient populations of the two trials, a 
practice is eligible to participate in both trials. 
 
3.2  
Guidelines for Screening (04-Oct-2019) 
3.2.1 Investigators should consider the factors below when selecting patients for this trial. 
Investigators also should consider all other relevant factors (medical and non-medical), as 
well as the risks and benefits of the study therapy, when deciding if a patient is an 
appropriate candidate for this trial. NRG Oncology is requesting a waiver of 
documentation of informed consent to screen eligible participants for the study. This 
process presents no more than minimal risk of harm to the subjects.   
 
3.2.2 Patients must have the psychological ability and general health that permits completion of 
the study requirements and required follow up. 
 
3.2.3 Screening (Step 0) 
This step is for screening purposes only. Sites must use a screening log to record all 
patients screened. Screening logs should be maintained with no identifying information. 
The NRG-CC007CD screening log template can be found on the CTSU website.  All 
screened patients will be entered on step 0 of the study. 
 
When patients are screened for this study they should be asked whether or not they have a 
PCP or cardiologist, then record the information on the screening log. If an eligible 
patient who chooses not to participate on the trial (either due to not wanting to obtain a 
PCP or another reason), the reason should also be recorded.  PCP can be a physician, 
physician assistant or nurse practitioner, in family practice or internal medicine.  A 
cardiologist also meets this requirement.  
 
The following script should be used to discuss with potential participants for this trial: 
““You could be eligible for a clinical trial focused on prostate cancer survivorship care. 
Please tell me if you have a primary care provider or a cardiologist. If you do not have a 
primary care provider or cardiologist, I need to know if you are willing to have a primary 
care provider.” 
 
Below are scenarios: 
• Patients with or without a PCP or cardiologist meeting eligibility criteria 3.3.1 and 
3.3.2 stated below will be entered on the screening step.   

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o Patients with a PCP or cardiologist meeting all eligibility criteria stated 
below will be consented and step 1: registration can take place 
immediately after step 1: screening. If a patient with a PCP or cardiologist 
is eligible but chooses not to consent for another reason, this reason will 
be collected on step 0 and no registration on step 1 is needed.  
o Patients without a PCP or cardiologist, but meeting all eligibility criteria 
stated below and are planning on establishing a PCP or cardiologist no 
more than 14 days after starting RT, can be consented.  Step 0: Screening 
and Step 1: Registration can occur once the PCP or cardiologist is 
established. Establishing a PCP or cardiologist means that an appointment 
to see this provider has been made.  
o Patients without a PCP or cardiologist, but meeting all other eligibility 
criteria below who do not plan on establishing a PCP or cardiologist will 
be entered on step 0: screening; however, they will not be consented or 
entered onto step 1: registration.  
 
3.3 
Patient Eligibility Criteria (24-Mar-2021) 
Prior to Registration (Step 1) 
A participant cannot be considered eligible for this study unless ALL of the following 
conditions are met. 
 
3.3.1 The participant must be able to complete required questionnaires in English. 
3.3.2 The participant must have a diagnosis of prostate adenocarcinoma that will be treated 
with RT plus ADT with curative intent.  Both definitive RT (intact prostate) and post-
prostatectomy RT patients are eligible.   
• The ADT must be planned for at least 4 months and must include LHRH agonist or 
LHRH antagonist.  
• ADT may have started for no more than 120 days before registration. 
 
3.3.3 The participant must have a primary care provider and/or cardiologist or plan to obtain 
one per Section 3.2.  
3.3.4 Comorbidities assessed at study entry using the ACE-27 instrument (located on the 
CTSU website). 
3.3.5  The patient or a legally authorized representative must provide study-specific informed 
consent prior to study entry. 
3.4 
Ineligibility Criteria  
Not applicable 
 
4. STUDY REQUIREMENTS (04-OCT-2019)  
Below is a list of required assessments on this study for both arms.  Time points of data 
collection are baseline, end of RT, 12 months post-RT, and 24 months post-RT. There will be no 

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data collection after 2 years.  All baseline data will be entered at the time of registration in OPEN 
except for the Coordination of Care and Patient Satisfaction with Care surveys regarding the 
PCP.  This is because patients who are planning to establish a PCP or cardiologist will not have 
seen their PCP or cardiologist at the time of registration (see Section 3.2.3).  
 
Below is an overview of the data collection that doesn’t relate to implementation of the TP 
and/or SCP.  The TP and SCP schedule are provided separately. Please note that detailed 
information for these assessments, times of collection and an arm specific informed consent 
form template will be provided to each practice based on the arm to which the practice has 
been randomized. The arm specific document will not be posted to the CTSU website and 
will be provided within 5 business days of practice notification of the randomization 
assignment. 
 
 
 
↓ 
↓ 
Prior to Registration  
(within 42 calendar 
days) 
12 months after 
completing RT 
(+/- 60 calendar 
days) 
24 months after 
completing RT 
(+/- 60 calendar 
days) 
• 
Records from PCP or cardiologist, if seen 
• 
Coordination of Care (completed twice) 
• 
Patient Satisfaction with Care (completed twice) 
• 
Brief Health Literacy Screen 
• 
ACE27 
• 
Results of fasting cholesterol panel* 
• 
Results of fasting glucose* 
• 
Blood pressure measurement 
• 
Age 
• 
Race 
• 
Smoking status 
• 
Treatment for hypertension (yes/no) 
• 
Presence of diabetes (yes/no) 
• 
Coordination of Care (completed twice) 
• 
Patient Satisfaction with Care (completed twice) 
• 
Records from PCP or cardiologist, if seen 
• 
Coordination of Care (completed twice) 
• 
Patient Satisfaction with Care (completed twice) 
• 
Brief Health Literacy Screen 
• 
ACE27 
• 
Results of fasting cholesterol panel 
• 
Results of fasting glucose 
• 
Blood pressure measurement 
• 
Age 
• 
Race 
• 
Smoking status 
• 
Treatment for hypertension (yes/no) 
• 
Presence of diabetes (yes/no) 
• 
Records from PCP or cardiologist, if seen 
• 
Coordination of Care (completed twice) 
• 
Patient Satisfaction with Care (completed twice) 
• 
Results of fasting cholesterol panel 
• 
Results of fasting glucose 
• 
Blood pressure measurement 
• 
Smoking status 
• 
Treatment for hypertension (yes/no) 
• 
Presence of diabetes (yes/no) 
• 
Prostate cancer recurrence (yes/no) 

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Assessment 
Notes 
Coordination of Care (twice) 
Both the Coordination of Care and Patient 
Satisfaction with Cancer Care questionnaires need 
to be completed twice, once regarding the cancer 
specialist and once regarding the PCP. 
 
If the patient did not see a PCP or cardiologist 
within 365 calendar days prior to each time point, 
the Coordination of Care and Patient Satisfaction 
with Care questionnaires will only be completed 
regarding the cancer specialist. 
Patient Satisfaction with Care (twice) 
Brief Health Literacy Screen 
Baseline only; To be completed within 42 
calendar days of registration 
ACE27 
Records from PCP or cardiologist, if seen 
Must record whether patient saw PCP or 
cardiologist within 365 calendar days of baseline 
and 24 months and if fasting glucose and fasting 
cholesterol were checked. 
Results of fasting cholesterol panel 
At baseline, only required if the patient has seen a 
PCP within 365 days prior to registration and had 
these blood tests checked.  At 24 months, these 
are assessed at NCORP practice unless medical 
records provide results within previous 365 
calendar days. 
Results of fasting glucose 
Blood pressure 
 
Age 
Baseline only 
Race 
Smoking status 
 
Treatment for hypertension 
Only required to record if this occurred or not 
(yes/no) at the specified time points. 
Presence of diabetes 
Prostate cancer recurrence 
 
 
 
This study uses Medidata Patient Cloud ePRO.  Remember to register the patient to the 
Patient Cloud ePRO.  For instructions on registering the patients, please refer to Section 
8.5 and the Medidata Patient Cloud ePRO operational instructions on the CTSU website 
for additional instructions.   
 
 
5. STUDY PROCEDURES (20-OCT-2020) 
The plans below depict the study arms. Randomization will be by practices (defined in 
Section 3.1). 
Participating practices must have a mechanism for delivering SCPs and must see at 
least 10 prostate cancer patients meeting study eligibility per year (see Section 3.1 for 

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practice eligibility criteria); however, no NCORP practice will be allowed to enroll 
more than 25 patients.  
5.1 
Eligible participants will be identified by the treating radiation oncologist, together with 
study staff. Institutions must record on a screening log the number of patients who are 
eligible; regardless of whether they have a PCP or cardiologist. Patients who do not have a 
PCP or cardiologist will not be registered to the trial. No further information about these 
patients will be collected (i.e. date of birth or other identifiable information). See Section 
3.2. 
5.1.1 Standard arm (Arm A): 
Appendix A will be provided by NRG Oncology to the lead institution of each practice, 
post randomization, which will include details about the intervention and assessments for 
Arm A. Note: the arm specific assessments will be sent to practices on Arm A only and 
not posted on CTSU. 
• Provided SCP template (see Appendix C ) must be used 
• Personnel utilized to create and review the SCP with the patient is per institutional 
protocol 
• Methods for sending the SCP to PCP can include: fax, mailed letter, and/or sent 
through electronic medical record system.  
• For patients who receive external beam RT and brachytherapy, “last week of RT” 
is defined by the last modality of planned radiation. 
 
5.1.2 Experimental arm (Arm B):  
The study intervention is enhanced survivorship care planning exposure which, in addition to 
SCP (identical to the standard arm), consists of several additional components. Appendix B will 
be provided by NRG Oncology to the lead institution of each practice, post randomization, which 
will include details about the additional components for Arm B. Note: the additional components 
for Arm B will be sent to practices on Arm B only and not posted on the CTSU.  
 
6. TREATMENT MODIFICATIONS/MANAGEMENT 
Not applicable. 
 
7. ADVERSE EVENTS REPORTING REQUIREMENTS 
Not applicable. 
 
 
 
 

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8. REGISTRATION AND STUDY ENTRY PROCEDURES (04-OCT-2019) 
 
Practice Randomization and Patient Registration 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.1 CTEP Registration Procedures and Access requirements for OPEN, Medidata Rave 
(20-Oct-2020) 
Food and Drug Administration (FDA) regulations and National Cancer Institute (NCI) policy 
require all individuals contributing to NCI-sponsored trials to register and to renew their 
registration annually.  To register, all individuals must obtain a Cancer Therapy Evaluation 
Program (CTEP) Identity and Access Management (IAM) account at 
https://ctepcore.nci.nih.gov/iam.  In addition, persons with a registration type of Investigator 
(IVR), Non-Physician Investigator (NPIVR), or Associate Plus (AP) must complete their 
annual registration using CTEP’s web-based Registration and Credential Repository (RCR) at 
(https://ctepcore.nci.nih.gov/rcr.   
RCR utilizes five person registration types. 
• IVR — MD, DO, or international equivalent; 
• NPIVR — advanced practice providers (e.g., NP or PA) or graduate level researchers 
(e.g., PhD); 
Practice Submits LOI to NRG Oncology 
Once LOI is approved by NRG Oncology, remaining PSRs 
can be completed and submitted to RSS 
Once all PSRs are satisfied, NRG Oncology will randomize the 
practice and provide arm assignment to designated point person 
Practice can begin to screen patients 
All screened patients are entered onto the screening step (Step 0)  
Screened patient DID NOT consent to 
participate on the trial 
Screened patient DID consent to 
participate on the trial 
No further steps are taken 
Patient is registered onto the study (Step 1) 

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• AP — clinical site staff (e.g., RN or CRA) with data entry access to CTSU 
applications such as the Roster Update Management System (RUMS), OPEN, Rave,, 
acting as a primary site contact or with consenting privileges; 
• Associate (A) — other clinical site staff involved in the conduct of NCI-sponsored 
trials; and 
• Associate Basic (AB) — individuals (e.g., pharmaceutical company employees) with 
limited access to NCI-supported systems. 
RCR requires the following registration documents: 
Documentation Required 
IVR NPIVR AP 
A 
AB 
FDA Form 1572 
✔ 
✔ 
 
 
 
Financial Disclosure Form 
✔ 
✔ 
✔ 
NCI Biosketch (education, training, employment, license, 
and certification) 
✔ 
✔ 
✔ 
GCP training 
✔ 
✔ 
✔ 
Agent Shipment Form (if applicable) 
✔ 
 
 
 
 
CV (optional) 
✔ 
✔ 
✔ 
 
An active CTEP-IAM user account and appropriate RCR registration is required to access all 
CTEP and Cancer Trials Support Unit (CTSU) websites and applications.  In addition, IVRs 
and NPIVRs must list all clinical practice sites and Institutional Review Boards (IRBs) 
covering their practice sites on the FDA Form 1572 in RCR to allow the following: 
• Addition to a site roster 
• Assign the treating, credit, consenting, or drug shipment (IVR only) tasks in OPEN 
• Act as the site-protocol Principal Investigator (PI) on the IRB approval 
 
In addition, all investigators acting as the Site-Protocol PI (investigator listed on the IRB 
approval), or consenting/treating/drug shipment investigator in OPEN, must be rostered at 
the enrolling site with a participating organization.  
 
Additional information can be found on the CTEP website at 
<http://ctep.cancer.gov/branches/pmb/associate_registration.htm>. For questions, please 
contact the RCR Help Desk by email at <RCRHelpDesk@nih.gov>. 
 
8.2 
Practice Randomization Assignment (24-Mar-2021) 
Each practice will be notified of their randomization assignment via an email to the lead 
institution within the practice (designated on the Letter of Intent [LOI]).  Once 35 
practices have met all study entry requirements, no other institutions, not part of the 535 
practices, will be able to enroll patients. Once a practice enrolls 25 patients; no institution 
within that practice will be able to enroll additional patients. If a practice does not enroll 
at least 1 patient within one year of randomization, the practice will be considered for 
possible removal and replacement.  The practice will be notified and provided with 
sufficient time, and assistance from the study team, to enroll at least 1 patient.  

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8.3 
Site Registration Requirements (24-Mar-2021) 
This study is supported by the NCI Cancer Trials Support Unit (CTSU). 
 
IRB Approval  
For CTEP and Division of Cancer Prevention (DCP) studies open to the National Clinical 
Trials Network (NCTN) and NCI Community Oncology Research Program (NCORP) 
Research Bases after March 1, 2019, all U.S.-based sites must be members of the NCI 
Central Institutional Review Board (NCI CIRB). In addition, U.S.-based sites must 
accept the NCI CIRB review to activate new studies at the site after March 1, 2019. Local 
IRB review will continue to be accepted for studies that are not reviewed by the CIRB, or 
if the study was previously open at the site under the local IRB. International sites should 
continue to submit Research Ethics Board (REB) approval to the CTSU Regulatory 
Office following country-specific regulations.  
Sites participating with the NCI CIRB must submit the Study Specific Worksheet for 
Local Context (SSW) to the CIRB using IRBManager to indicate their intent to open the 
study locally. The NCI CIRB’s approval of the SSW is automatically communicated to 
the CTSU Regulatory Office, but sites are required to contact the CTSU Regulatory 
Office at CTSURegPref@ctsu.coccg.org to establish site preferences for applying NCI 
CIRB approvals across their Signatory Network. Site preferences can be set at the 
network or protocol level. Questions about establishing site preferences can be addressed 
to the CTSU Regulatory Office by emailing the email address above or calling 1-888-651-
CTSU (2878). 
Sites using their local IRB or REB, must submit their approval to the CTSU Regulatory 
Office using the Regulatory Submission Portal located in the Regulatory section of the 
CTSU website. Acceptable documentation of local IRB/REB approval includes: 
• Local IRB documentation; 
• IRB-signed CTSU IRB Certification Form; and/or 
• Protocol of Human Subjects Assurance Identification/IRB 
Certification/Declaration of Exemption Form. 
In addition, the Site-Protocol Principal Investigator (PI) (i.e. the investigator on the 
IRB/REB approval) must meet the following criteria in order for the processing of the 
IRB/REB approval record to be completed:  
• Holds an Active CTEP status; 
• Rostered at the site on the IRB/REB approval and on at least one participating 
roster; 
• If using NCI CIRB, rostered on the NCI CIRB Signatory record; 
• Includes the IRB number of the IRB providing approval in the Form FDA 1572 in 
the RCR profile; and 
• Holds the appropriate CTEP registration type for the protocol.  
 
Additional Requirements For NRG-CC007CD Site Registration:  
• An active Federal Wide Assurance (FWA) number; 

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• An active roster affiliation with the Lead Protocol Organization (LPO) or a 
Participating Organization (PO);  
• Compliance with all protocol-specific requirements (PSRs). 
 
Protocol Specific Requirements For NRG-CC007CD:  
• Letter of Intent (LOI) completed and submitted by each practice to nrg-
cc007cd@NRGOncology.org (The form and instructions are posted on the CTSU 
website).  
• Once the LOI is approved, each PI and RA at a NCORP practice must complete 
NRG-CC007CD study specific training, which includes details related to the 
study and cultural competency. A training certificate is provided at the end of the 
training and will need to be completed and submitted to the CTSU via the 
Regulatory Submission Portal. See the CTSU website for the training memo and 
training slides. 
 
Downloading Site Registration Documents:   
Download the site registration forms from the protocol-specific page located on the 
CTSU members’ website. Permission to view and download this protocol and its 
supporting documents is restricted based on person and site roster assignment. To 
participate, the institution and its associated investigators and staff must be associated 
with the LPO or a Protocol Organization (PO) on the protocol. One way to search for a 
protocol is listed below. 
• Log on to the CTSU members’ website (https://www.ctsu.org) using your CTEP-
IAM username and password; 
• Click on Protocols in the upper left of the screen 
o Enter the protocol number in the search field at the top of the protocol tree, 
or 
o Click on the By Lead Organization folder to expand, then select NRG and 
protocol number NRG-CC007CD; 
• Click on Documents, select Site Registration, and download and complete the 
forms provided. (Note: For sites under the CIRB initiative, IRB data will load 
automatically to the CTSU.)  
 
 
 
 
 
Submitting Regulatory Documents:  
 
 
Submit required forms and documents to the CTSU Regulatory Office via the Regulatory 
Submission Portal on the CTSU website.  
To access the Regulatory Submission Portal log in to the CTSU members’ website, go to 
the Regulatory section and select Regulatory Submission. 
 

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Institutions with patients waiting that are unable to use the Regulatory Submission Portal 
should alert the CTSU Regulatory Office immediately at 1-866-651-2878 in order to 
receive further instruction and support.  
 
Checking Your Site’s Registration Status: 
Site registration status may be verified on the CTSU members’ website.  
• Click on Regulatory at the top of your screen; 
• Click on Site Registration; 
• Enter your 5-character CTEP Institution Code and click on Go 
▪ Additional filters are available to sort by Protocol, Registration Status, Protocol 
Status, and/or IRB Type. 
 
Note: The status shown only reflects institutional compliance with site registration 
requirements outlined within the protocol. It does not reflect compliance with protocol 
requirements for individuals participating on the protocol or the enrolling investigator’s 
status with the NCI or their affiliated networks. 
 
8.4 
Patient Enrollment (20-Oct-2020) 
Patient registration can occur only after evaluation for eligibility is complete, eligibility 
criteria have been met, and the study site is listed as ‘approved’ in the CTSU RSS.  Patients 
must have signed and dated all applicable consents and authorization forms.   
 
8.4.1 Oncology Patient Enrollment Network (OPEN) 
The Oncology Patient Enrollment Network (OPEN) is a web-based registration system 
available on a 24/7 basis. OPEN is integrated with CTSU regulatory and roster data and 
with the LPOs registration/randomization systems or Theradex Interactive Web Response 
System (IWRS) for retrieval of patient registration/randomization assignment. OPEN will 
populate the patient enrollment data in NCI’s clinical data management system, Medidata 
Rave. 
Requirements for OPEN access:   
• A valid CTEP-IAM account; 
• To perform enrollments or request slot reservations:  Must be on a LPO roster, 
ETCTN Corresponding roster, or participating organization  roster with the role of 
Registrar. Registrars must hold a minimum of an AP registration type; and 
• Have an approved site registration for a protocol prior to patient enrollment. 
 
To assign an Investigator (IVR) or Non-Physician Investigator (NPIVR) as the treating, 
crediting, consenting, drug shipment (IVR only), or receiving investigator for a patient 
transfer in OPEN, the IVR or NPIVR must list the IRB number used on the site’s IRB 
approval on their Form FDA 1572 in RCR.  
Prior to accessing OPEN, site staff should verify the following: 

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• Patient has met all eligibility criteria within the protocol stated timeframes; and  
• All patients have signed an appropriate consent form and HIPAA 
authorization form (if applicable). 
Note:  The OPEN system will provide the site with a printable confirmation of 
registration and treatment information. Please print this confirmation for your records.  
Access OPEN at https://open.ctsu.org or from the OPEN link on the CTSU members’ 
website. Further instructional information is in the OPEN section of the CTSU website at 
https://www.ctsu.org or https://open.ctsu.org. For any additional questions, contact the 
CTSU Help Desk at 1-888-823-5923 or ctsucontact@westat.com. 
 
 
In the event that the OPEN system is not accessible, participating sites can contact NRG 
web support for assistance with web registration: websupport@acr.org or call the NRG 
Registration Desk at 215-574-3191, Monday through Friday, 8:30 a.m. to 5:00 p.m. ET. 
The registrar will ask the site to fax in the eligibility checklist and will need the registering 
individual’s e-mail address and/or return fax number. This information is required to assure 
that mechanisms usually triggered by the OPEN web registration system (e.g. drug 
shipment and confirmation of registration) will occur.  
 
8.5 
Medidata Patient Cloud ePRO Registration (20-Oct-2020) 
This study includes the use of Medidata Patient Cloud ePRO (electronic patient-reported 
outcomes). After the patient is registered to the trial via OPEN, and if the patient is 
willing to participate in electronic data collection, the site staff will then complete a 
registration for the patient to the Patient Cloud ePRO through iMedidata. Note: Site staff 
must have already completed required eLearning for the Patient Cloud ePRO application 
to register a patient and information about the training is in the Medidata Patient Cloud 
ePRO Operational Instructions on the CTSU website. The registration to the Patient 
Cloud ePRO will create a unique patient registration code that the site staff will provide 
to the patient. The patient (with assistance from the site staff) should be instructed to 
download the Patient Cloud ePRO app onto his/her own device (IOS, Android, phone or 
tablet) and use the unique patient registration code to create an account. Once the 
patient's account is set up, the patient will be able to complete the submission of patient 
reported outcomes electronically for the trial. There are multiple versions of the app 
available. The Patient Cloud App (the version with the cloud logo) will be used on this 
study. Ensure that the patient downloads the correct version of the ePRO app. Note only 
1 version of the app is active per protocol. 
 
For sites providing a shared institutional device for use by multiple patients on site:  
• The site staff should assist the patient with access and registration to the Patient 
Cloud ePRO app, and the patient can then complete the electronic data submission 
independently.  Site staff may need to assist patients with logging on to the device at 
each visit.  
8.5.1 CRA Patient Registration Instructions for ePRO  

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Please visit the CTSU website for reference information on Patient Cloud ePRO for 
CRAs.  
i. 
The subject registration process starts in iMedidata.  Begin by selecting the Patient 
Cloud ePRO Registration link for your study 
ii. 
The patient management app will display, select your STUDY and SITE from the 
drop downs and click Launch. 
iii. 
Now you can register your first patient. Create a subject ID and select a Country / 
Language from the drop down, (these are the only required data fields). The subject 
initials are optional, but are helpful in identifying which subject ID maps with which 
activation code. When finished, click Add. 
iv. 
The subject added and will include the date the patient was added, the subject ID, 
subject initials, (if included) and a unique auto-generated activation code. The 
activation code is unique for each patient and linked to the subject ID, it is not 
interchangeable. In addition, there is a status section, which indicates if the patient 
has registered. When the patient has registered the status will change from "invited" 
to "registered". 
Reminder- site staff must have already completed the Medidata Patient Cloud training in 
order to register study participants. Please visit the CTSU website for information on 
Patient Cloud ePRO for CRAs.   
 
9. DRUG INFORMATION 
Not applicable 
10. PATHOLOGY/BIOSPECIMEN 
Not applicable 
11. SPECIAL STUDIES (NON-TISSUE)  
11.1 
Adherence to AHA guideline recommendations (04-Oct-2019) 
Adherence to AHA guideline recommendations is assessed using data collected at the24 
month time point, as described in Section 4. Guideline adherence requires a “yes” 
response to all 3 elements: 
1) The patient saw his PCP or cardiologist within the previous 365 days; 
2) Fasting glucose was checked within the previous 365 days; 
3) Fasting cholesterol panel was checked within the previous 365 days. 
 
11.2 
Cardiovascular disease (CVD) risk score 
CVD score will be calculated by NRG Oncology according to the 2013 ACC/AHA 
Guidelines on the Assessment of Cardiovascular Risk (Levine 2010). This is assessed 
using data collected at baseline and the 24 month time point, as described in Section 4. 
The following data elements are required for this score calculation: Age, race, 
smoking status, hypertension treatment (yes/no), fasting total cholesterol and HDL, 
systolic blood pressure, and diabetes (yes/no). Systolic blood pressure should be 
measured by enrolling NCORP practice at each time point. Fasting glucose and total 
cholesterol and HDL should also be measured by the NCORP practice, unless 
documented values can be obtained by medical records within 365 calendar days prior to 
the 24 month time point. If a patient has multiple fasting glucose/total cholesterol/HDL 

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results within 365 days, the results most recent to the time point should be used. Patients 
will only have the CVD risk score calculated at baseline if they saw a PCP or cardiologist 
within 365 days prior to registration and had the required blood tests checked.   
11.3 
Patient-reported outcomes   
Brief Health Literacy Screen (BHLS) (3 items, no subscales) – completed at baseline 
only. BHLS is a validated instrument that consists of three items on a 5-point response 
scale. After reverse-scoring the item addressing confidence with forms, responses to the 
three items are summed; scores range between 3 and 15, with higher scores indicating 
higher subjective health literacy (Wallston et al, 2014). The BHLS can be found in on the 
CTSU website.   
 
Items and Response Options for the Brief Health Literacy Screen include: 
• How confident are you filling out medical forms by yourself? (Extremely, Quite a bit, 
Somewhat, A little bit, Not at all)  
• How often do you have someone help you read hospital materials? (All of the time, 
Most of the time, Some of the time, A little of the time, None of the time)  
• How often do you have problems learning about your medical condition because of 
difficulty understanding written information? (All of the time, Most of the time, Some 
of the time, A little of the time, None of the time)  
 
Coordination of care (6 items): The Components of the Primary Care Index is a 
validated instrument specifically designed to measure aspects of primary care delivery 
from the patient’s perspective (Flocke 1997). The coordination of care subscale measures 
“the patients’ perception of their physician’s knowledge of other visits and visits to 
specialists, as well as follow-up of problems.”  
 
Patients respond to each item on a 6-point Likert scale: strongly disagree (1),  to strongly 
agree (6). Scoring is based on a mean of the 6 items, with negatively-worded questions 
scored in reverse. A higher score indicates better coordination of care. Participants will 
complete the questionnaire twice per time point (baseline, 12 months and 24 months): 
one set of questionnaires is regarding coordination/satisfaction toward the radiation 
oncologist, one set toward PCP (or cardiologist if patient does not have a PCP). 
 
Patient Satisfaction with Care (18 items, no subscales): The NCI-funded Patient 
Navigation Research Programs developed and validated this instrument, specifically to 
evaluate patient-reported outcomes related to satisfaction with cancer-related care. This 
instrument has been used in patients from diverse backgrounds (Jeanne-Pierre 2011) and 
was developed to assess potential benefits (i.e. satisfaction) of patient navigation.  
 
This tool was developed and validated to be administered by a member of the research 
staff.  Patients respond to each item on a 5-point Likert scale from strongly disagree (1) 
to strongly agree (5). A total scale score is calculated by adding scores on all 18 items, 
with a higher score indicating higher satisfaction (Jeanne-Pierre 2011; Fiscella 2012).  
 

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12.  
DATA MANAGEMENT/COLLECTION (20-OCT-2020)  
Medidata Rave is a clinical data management system being used for data collection for 
this trial/study. Access to the trial in Rave is controlled through the CTEP-IAM system 
and role assignments.  
Requirements to access Rave via iMedidata:  
• 
A valid CTEP-IAM account;  
• 
Assigned a Rave role on the LPO or PO roster at the enrolling site of: Rave CRA, 
Rave Read Only, Rave CRA (LabAdmin), Rave SLA, or Rave Investigator.  
Rave role requirements: 
o Rave CRA or Rave CRA (Lab Admin) role must have a minimum of an 
Associate Plus (AP) registration type; 
o Rave Investigator role must be registered as a Non-Physician Investigator 
(NPIVR) or Investigator (IVR); and 
o Rave Read Only role must have at a minimum an Associates (A) 
registration type. 
Refer to https://ctep.cancer.gov/investigatorResources/default.htm for registration types 
and documentation required. 
 
Upon initial site registration approval for the study in Regulatory Support System (RSS), 
all persons with Rave roles assigned on the appropriate roster will be sent a study 
invitation e-mail from iMedidata.  To accept the invitation, site users must log into the 
Select Login (https://login.imedidata.com/selectlogin) using their CTEP-IAM user name 
and password, and click on the “accept” link in the upper right-corner of the iMedidata 
page.  Site staff will not be able to access the study in Rave until all required Medidata 
and study specific trainings are completed.  Trainings will be in the form of electronic 
learnings (eLearnings), and can be accessed by clicking on the link in the upper right 
pane of the iMedidata screen. If an eLearning is required and has not yet been taken, the 
link to the eLearning will appear under the study name in iMedidata instead of the Rave 
EDC link; once the successful completion of the eLearning has been recorded, access to 
the study in Rave will be granted, and a Rave EDC link will display under the study 
name. 
Site staff that have not previously activated their iMedidata/Rave account at the time of 
initial site registration approval for the study in RSS will also receive a separate invitation 
from iMedidata to activate their account.  Account activation instructions are located on 
the CTSU website in the Data Management section under the Rave resource materials 
(Medidata Account Activation and Study Invitation Acceptance).  Additional information 
on iMedidata/Rave is available on the CTSU Members' website in the Data Management 
> Rave section at www.ctsu.org/RAVE/ or by contacting the CTSU Help Desk at 1-888-
823-5923 or by e-mail at ctsucontact@westat.com. 
12.1 
Summary of Data Submission 
Blank Rave forms and Summary of Data Submission are available on the CTSU website. 

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12.2 
Quality Portal (04-Oct-2019) 
The Data Quality Portal (DQP) provides a central location for site staff to manage 
unanswered queries and form delinquencies, monitor data quality and timeliness, 
generate reports, and review metrics.  
The DQP is located on the CTSU members’ website under Data Management. 
The Rave Home section displays a table providing summary counts of Total 
Delinquencies and Total Queries. DQP Queries, DQP Delinquent Forms and the 
DQP Reports modules are available to access details and reports of unanswered 
queries, delinquent forms, and timeliness reports. Review the DQP modules on a 
regular basis to manage specified queries and delinquent forms. 
The DQP is accessible by site staff that are rostered to a site and have access to 
the CTSU website. Staff that have Rave study access can access the Rave study 
data using a direct link on the DQP. 
To learn more about DQP use and access, click on the Help icon displayed on the 
Rave Home, DQP Queries, and DQP Delinquent Forms modules. 
Note: Some Rave protocols may not have delinquent form details or reports specified on 
the DQP. A protocol must have the Calendar functionality implemented in Rave by the 
Lead Protocol Organization (LPO) for delinquent form details and reports to be available 
on the DQP. Site staff should contact the LPO Data Manager for their protocol regarding 
questions about Rave Calendaring functionality.   
 
12.3 
Global Reporting/Monitoring 
This study will be monitored by the Clinical Data Update System (CDUS) version 3.0. 
Cumulative CDUS data will be submitted quarterly to CTEP by electronic means. 
Reports are due January 31, April 30, July 31, and October 31. 
 
13. STATISTICAL CONSIDERATIONS 
13.1 
Study Design (20-Oct-2020) 
This is a prospective, cluster-randomized trial of survivorship care plans (SCPs).  
Practices (defined in Section 3.1) will be randomized using block randomization to the 
standard arm (one-time SCP given during the last week of radiation) or experimental arm. 
The TP and SCP will be standardized for this trial, and based upon the published ASTRO 
SCP template (Chen 2015).  The SCP will indicate that the patient received androgen 
deprivation therapy and outline the American Heart Association guideline (Levine 2010) 
recommendation for primary care follow-up. The SCP is reviewed with the patient and 
sent to the PCP and/or cardiologist.  
 
The target maximum accrual is 544 patients from approximately 35 practices.  Patients 
will be analyzed according to the intent-to-treat principle using all randomized at-risk 
patients. 
 
13.2 
Study Endpoints 
13.2.1 Primary Endpoint 

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Patients who saw a primary care provider (PCP) or cardiologist and had fasting blood 
glucose and fasting cholesterol checked by their PCP (or cardiologist) in Year 2 (13-24 
months) after completing RT. This will be assessed using medical record abstraction. 
13.2.2 Secondary Endpoints 
• Calculated CVD risk score 
• Coordination of care with respect to the PCP or cardiologist 
• Satisfaction with care with respect to the PCP or cardiologist 
• Eligible patients with a PCP or cardiologist screened 
• Current practice related to SCP delivery and prostate cancer survivor monitoring 
 
13.2.3 Exploratory Endpoints 
• Coordination of care with respect to the cancer specialist 
• Satisfaction of care with respect to the cancer specialist 
 
13.3 
Primary objectives and study design (20-Oct-2020) 
13.3.1 Primary Endpoint and Hypothesis 
The primary endpoint is the proportion of patients who saw a PCP (or cardiologist) and 
had fasting blood glucose and fasting cholesterol checked in Year 2 (13-24 months) after 
completing RT.   The primary hypothesis is that increased doses of SCP will improve 
adherence to the American Heart Association recommendations for monitoring of CVD 
risk factors in prostate cancer survivors as compared to a one-time SCP. 
13.3.2 Definition of Primary Endpoint and How It Will Be Analyzed 
The primary endpoint will be assessed at the 24 month time point after completing RT. 
Medical records from the PCP and cardiologist will be reviewed to determine if each 
patient received care that met all 3 AHA guideline recommendations within 365 calendar 
days prior to this time point. Patients who received care that met all 3 criteria have “yes” 
for the primary endpoint; otherwise, “no” for the primary endpoint.  
The primary endpoint will be evaluated on the individual level using an adjusted chi-
square test that computes clustering correction factors computed separately in each 
treatment (Donner 1989) and tested with a 2-sided type I error of 0.05.  A generalized 
estimating equation (GEE) (Liang 1986), adjusting for practice as a random covariate as 
part of a 2 level hierarchy (patients nested within clusters) will be used to determine the 
effect of intervention, ADT duration, person delivering the SCP, whether the patient saw 
a PCP or cardiologist, and possible confounders such as age, race, and number of 
baseline cardiovascular disease risk factors (none, hypertension, diabetes, 
hypercholesterolemia, and/or known coronary heart disease).   
Since patients with missing data (either in part or whole) will be excluded from the 
primary endpoint analysis, a sensitivity analysis will be conducted assuming patients who 
have missing data at 24 months did not have their glucose and cholesterol checked or see 
their PCP or cardiologist. 

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Subgroup analyses based on race and ethnicity as well as in men without prostate cancer 
recurrence will be conducted where feasible.  It is projected that 37 patients will be 
Hispanic or Latino and 117 will be of a minority race.  In order to increase sample size 
within this subgroup, race and ethnicity will be combined to assess treatment effect 
(noting that 10 patients are projected to be both Hispanic and of a minority race).  
Additional subgroup analyses for Black or African American men and Hispanic or Latino 
men will be conducted on an exploratory basis.  The rate of prostate cancer recurrence by 
2 years is expected to be too low to allow for a subgroup analysis of progressed patients 
but a subgroup analysis of recurrence-free patients at 2 years will be conducted. 
13.3.3 Sample Size and Power Calculations 
The primary endpoint is the proportion of patients who saw a primary care provider in 
Year 2 after completing RT and had their glucose and cholesterol checked. This is a 
cluster randomized study in which practices will be randomized to the standard or 
experimental arm.  Ideally, each practice would enroll the same number of patients; 
however, that is unlikely in the NCORP. Therefore, sample size for a patient-level 
randomization will be determined and then inflated by a design effect that also adjusts for 
unequal cluster size (Rutterford 2015).  It is assumed that there will be approximately 9 
patients enrolled per practice (𝑛̅).  A coefficient of variation (CV) of cluster size of 0.5 
will be assumed (van Breukelen 2012) along with an intra-cluster correlation (ρ) of 0.05. 
van Breukelen recommends 0.0 < ρ < 0.10 (van Breukelen 2012).  Based on national data 
from 2011-2015 [investigator’s analysis of National Health Interview Survey/NHIS data, 
unpublished], 59.83% of prostate cancer survivors met the primary endpoint of this study. 
Clinically, an absolute improvement by 15% for the intervention arm is deemed a 
clinically-meaningful difference (thus, 74.8%). This improvement is reasonable based on 
a recently reported randomized trial which demonstrated that providing PCP with 
cardiovascular disease guidelines vs routine care improved physician adherence to anti-
hypertensive medication use by 30%, and patient-reported adherence by 19% (Wei 
2017).   
Using a 2-sample test of proportions with a 2-sided α=0.05, 300 patients would provide 
80% statistical power.  Using equation 17 from Rutterford et al (Rutterford 2015), the 
design effect is: 
𝐷𝐸= 1 + ((𝐶𝑉2 + 1)𝑛̅ −1)𝜌= 1.51. 
This results in 454 evaluable patients.  After inflating by 5% for loss to follow-up and 5% 
due to consent withdraw as patients with missing data will not be included in the analysis, 
504 patients from approximately 50 practices will be required for this study. 
 
13.3.4 Revised Sample Size Calculation  
The study design and sample size calculation are being modified in order to allow practices to 
enroll more patients and reduce the number of practices required.  Initially ρ=0.05 and CV=0.5 
but will now be ρ=0.4 and CV=0.45.  This is because the primary endpoint is dependent 
on the patient’s PCP/cardiologist who is not participating in the trial and is likely to be 
different from patient to patient within the same practice, thus decreasing the variance 
between clusters.  After simulating likely accrual scenarios based on the current accrual 
by each practice, a slightly lower CV (calculated as the standard deviation/mean) is 
reasonable.  Increasing the average number of patients from 𝑛̅=9 to 𝑛̅=14 will increase 

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the number of evaluable patients to 490 from approximately 35 practices.  Inflating by 
10% for consent withdraw and loss to follow-up results in a maximum target accrual of 
544 patients.  The current consent withdraw rate is 1.6%.  The target accrual is 527 after 
inflating by 7% (2% for consent withdraw and 5% for loss to follow-up).  The consent 
withdraw rate will be monitored semi-annually and if it remains below 2%, then the trial 
will close to accrual once 527 patients are enrolled. Otherwise, the trial will continue 
until 544 patients are enrolled.  The maximum accrual is increased to 25 patients 
per practice. 
 
13.4 
Study Monitoring of the Primary Objective 
The NRG Oncology Data Monitoring Committee (DMC) will review the study twice a 
year with respect to patient accrual and data submission. The DMC also will review the 
study on an “as needed” basis. No interim analysis is planned.  
 
Once 10 practices have been enrolled, a hold will be put on randomizing additional 
practices.  This hold will serve to ensure that all questions and issues regarding the 
practice randomization and study enrollment processes have been resolved.  We 
anticipate this hold to take 1-2 months.  The 10 randomized practices are able to continue 
screening and registering patients during this randomization hold. 
 
13.5 
Accrual Considerations 
Many prostate cancer studies utilizing ADT conducted by NRG Oncology have high 
accrual rates. For example, RTOG 0534, a phase III trial of short-term ADT with pelvic 
lymph node or prostate bed only RT in prostate cancer patients with a rising PSA after 
radical prostatectomy, accrued patients at a rate of 23.5 per month. RTOG 0924, a phase 
III trial of ADT with high dose RT with or without whole pelvic RT in unfavorable 
intermediate or favorable high risk prostate cancer, is currently enrolling patients at a rate 
of 36.7 per month. Given the broad eligibility, the ability to be on a treatment trial as well 
as this trial, but accounting for the limited number of sites, the projected accrual is 20 
patients per month. Thus, this study is projected to accrue 544 patients in 25 months, after 
a ramp up period of 6 months with negligible accrual. The primary endpoint will be 
reported approximately 4 years from study activation, once all patients have had at least 2 
years on study.  Accrual will be monitored by NRG Oncology’s DMC according to DCP 
guidelines. 
 
Given that African American men are disproportionately affected by prostate cancer, this 
study will aim to recruit African American men to consist of at least 15% of the study 
sample.  Enrollment by ethnicity and race will be monitored on a semi-annual basis.  If 
the proportion of African American men falls below 17%, the study chairs will reach out 
to practices to provide individualized recommendations to recruit more minorities, 
specifically African American men.  
 
13.6 
Secondary Endpoints (04-Oct-2019) 
13.6.1 Secondary Endpoints and Hypotheses 
• Calculated CVD risk score using the American Heart Association Risk Calculator 

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Hypothesis: Increased doses of SCP will reduce calculated CVD risk score as 
compared to a one-time SCP. 
• Coordination of care of the PCP or cardiologist as measured by the Components of 
the Primary Care Index  
Hypothesis: Increased doses of SCP will improve patient-reported coordination of 
PCP or cardiologist care as compared to a one-time SCP. 
• Satisfaction with care of the PCP or cardiologist as measured by the Patient 
Satisfaction with Care questionnaire 
Hypothesis: Increased doses of SCP will improve patient-reported satisfaction with 
PCP or cardiologist care as compared to a one-time SCP. 
• To explore whether high health literacy levels are associated with improved patient-
reported coordination of care and satisfaction with care. 
• Collect number of eligible screened patients who do not have a PCP or cardiologist 
• Describe current practice related to SCP delivery and prostate cancer survivor 
monitoring 
 
13.6.2 Definitions of Secondary Endpoints and How These Will be Analyzed 
 
Calculated CVD Risk Score 
The American Heart Association Risk Calculator (Goff et al, 2013) will be used to calculate 
CVD risk score at baseline and at 24 months.  For patients who have not seen a PCP within 
365 days prior to registration, and therefore do not have results for fasting glucose and 
cholesterol levels at baseline, baseline CVD risk score will not be calculated.  
 
Factors included in the Risk Calculator are: male/female, (all participants are male in this 
trial), age, race (White, African American, Other), HDL, total cholesterol, systolic blood 
pressure, diabetes (yes/no), treatment for hypertension (yes/no), smoker (yes/no). It is 
expected that all patients will be able to be assessed for the 24 month endpoint.  
Specifically, for participants with missing data at 24 months due to lack of primary care 
follow-up (i.e. the patient did not see a PCP or cardiologist within 365 days prior to this 
time point), necessary tests for CVD score calculation will be assessed by study personnel 
at 24 months after completing RT so that all participants contribute data toward this 
secondary endpoint. If patients are missing the appropriate variables to calculate CVD risk 
score regardless of whether the patient saw his PCP, they will be excluded from the analysis 
however this rate is expected to be low.  If this rate is ≥ 15% appropriate missing data 
techniques, as described below for the PRO analysis, will be utilized.  A linear mixed model 
(Laird 1982) with practice as a random covariate as part of a 2 level hierarchy (patients 
nested within clusters) will be used to compare the treatment arms using a significance 
level of 0.05. 
 
Patient-Reported Outcomes  
An expected benefit of the intervention is to improve coordination of care and patient 
satisfaction with care: both are ideally assessed by patient report using validated 
instruments. Both PROs will be collected twice at each time point: one in regards to the 
cancer specialist and one for the PCP or cardiologist.   
 

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It is expected that the Coordination of Care and Satisfaction with Cancer Care for the 
PCP or cardiologist may have a higher missing data rate on the control arm as these 
patients may not see their PCP.  Therefore, the distribution of the Coordination of Care 
and Satisfaction with Cancer Care for the PCP or cardiologist will be provided for the 
entire study cohort only and not by arm; statistical testing using a t-test (Wilcoxon test if 
the data is not normal) will only be performed if there is sufficient data on the control 
arm to allow for between treatment arm differences. 
 
A linear mixed effects model with practice as a random covariate as part of a 3 level 
hierarchy (surveys nested within patients nested within clusters) will be used to assess the 
effect of the intervention on the Coordination of Care and Satisfaction with Cancer Care 
for the PCP or cardiologist, with baseline score as a covariate, at 12 months and 24 
months after completing RT (Liang 1986).  Similar models will be used to determine the 
effect of various baseline covariates, including ADT duration, number of cardiovascular 
risk factors, person delivering the SCP, BHLS score, and race/ethnicity on the 
Coordination of Care and Satisfaction with Cancer Care scores.  Treatment arm, time, 
and their interaction will be included in the models.   
 
Missing data will be assessed.  If ≥15% of the data is missing at any time point for any of 
the PROs, patient characteristics will be compared between patients with completed 
assessments and those with missing assessments. If the missingness is determined to be 
ignorable, no additional analyses need to occur since mixed effects modeling is valid 
under data that is missing at random (MAR). If the missingness is determined to be non-
ignorable, other methods, such as imputation and pattern mixture models, may be 
performed (Fairclough 2010).  Ceiling effects will be evaluated for both tools to aid in the 
interpretation of the results.  
 
Screening study 
Each NCORP practice will screen (step 0) and keep a log of all patients who are eligible, 
regardless of whether the patient has an existing PCP and/or cardiologist.  The only 
information that will be collected is whether the patient signed consent (Y/N), is eligible 
excluding the PCP and/or cardiologist requirement (Y/N), if the patient has a PCP and/or 
cardiologist (including one that was recently established) (Y/N), and the reason for not 
registering to the trial (such as no PCP/cardiologist nor will obtain one, doesn’t speak 
English, patient not interested in participating on a clinical trial, other). Patients who have 
a PCP and/or cardiologist or establish one as outlined in Section 3.2.3, will provide 
additional eligibility information when registered (step 1). This will provide the study 
team an idea of the amount of potential bias caused in this study due to the exclusion of 
these patients. Since no patient level information will be collected, no additional analyses 
will be performed or adjustments will be made to the specified analyses. The percentage 
of the enrolled patients out of all eligible patients (excluding the PCP requirement) will 
be provided along with the percentages broken down by practice. 
 
Current SCP practice 
Information regarding participating sites current practices for treatment plans, SCP, and 
fasting blood glucose and cholesterol testing will be collected prior to randomization.  

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Descriptive statistics, such as frequencies for the number of sites that currently use a 
treatment plan and/or SCP, and routinely perform testing and means for the percent of 
patients and/or their PCPs who receive a treatment plan and/or SCP, will be performed.  
Comparisons by arm will be made using a chi square test or t-test.  If significant 
differences exist, at a two-sided significance level of 0.05, the respective covariates may 
be added to the models for the primary and secondary endpoints. 
13.7 
Exploratory Endpoints 
Patient-Reported Outcomes  
The distribution of the Coordination of Care and Satisfaction with Cancer Care for the 
cancer specialist by treatment arm and the entire study cohort will be provided with 
between treatment arm differences tested using a t-test (Wilcoxon test if the data is non-
normal).   
A linear mixed effects model with practice as a random covariate as part of a 3 level 
hierarchy (surveys nested within patients nested within clusters) will be used to assess the 
effect of the intervention on the Coordination of Care and Satisfaction with Cancer Care 
for the cancer specialist, with baseline score as a covariate, at 12 months and 24 months 
after completing RT (Liang 1986).  Similar models will be used to determine the effect of 
various baseline covariates, including ADT duration, number of cardiovascular risk 
factors, person delivering the SCP, BHLS score, and race/ethnicity on the Coordination 
of Care and Satisfaction with Cancer Care scores.  Treatment arm, time, and their 
interaction will be included in the models.  Missing data will be assessed as specified in 
Section 13.6.2. 
13.8 
Gender/Ethnicity/Race Distribution (20-Oct-2020) 
NRG Oncology remains committed to improving the awareness and involvement of 
racial and ethnic minority participants and underserved populations and will devote 
financial and personnel resources to accomplishing those goals.  Since this trial is only 
open NCORP practices, there will be no international accrual.  The prognostic effect of 
race/ethnicity will be evaluated using statistical models.  Effects for the different cultural 
or racial groups will be compared between treatment arms, depending on the 
distributions.  No differences across the patient subsets below are anticipated. 
 
Expected racial and ethnic composition of NRG-CC007CD 
DOMESTIC PLANNED ENROLLMENT REPORT 
Racial 
Categories 
Ethnic Categories 
Total 
Not Hispanic or Latino 
Hispanic or Latino 
Female 
Male 
Female 
Male 
American 
Indian/Alaska 
Native 
0 
7 
0 
1 
8 
Asian 
0 
12 
0 
0 
12 
Native 
Hawaiian or 
0 
6 
0 
1 
7 

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DOMESTIC PLANNED ENROLLMENT REPORT 
Other Pacific 
Islander 
Black or 
African 
American 
0 
92 
0 
1 
93 
White 
0 
388 
0 
31 
419 
More than One 
Race 
0 
2 
0 
3 
5 
Total 
0 
507 
0 
37 
544 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX A: ARM A STUDY REQUIREMENTS 
 
This document will include further details about requirements for Arm A. It will be provided to 
each lead institution of a practice at time of site randomization only.  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX B: ARM B STUDY REQUIREMENTS 
 
This document will include further details about requirements for Arm B. It will be provided to 
each lead institution of a practice at time of site randomization only.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX C: SURVIVORSHIP CARE PLAN (SCP) (04-OCT-2019) 
 
Dear ____________, your patient was diagnosed with prostate cancer and received the following 
treatment. The treatment received and potential side effects are described below. 
 
Patient History 
Patient name:  ________________________ Date of birth: __/__/____ MRN: _______________ 
Treating radiation oncologist: _______________________   Phone: ________________________ 
Primary care provider: _____________________________  Phone: ________________________ 
Surgeon: __________________________________________ Phone: ________________________ 
Medical oncologist: _________________________________ Phone: ________________________ 
Other providers: ___________________________________ Phone: ________________________ 
 
Diagnosis 
Primary site: ______________________________ 
Histology: ___________________________ 
 
PSA at diagnosis (ng/mL): 
  
Biopsy Gleason score:  
Clinical stage: 
 
Surgery:  ☐ Prior to RT 
☐ Planned to follow RT 
 
☐ Not planned 
 
 
 
Systemic treatment (e.g. hormone therapy):  
☒ Yes        
☐ No 
 
☐ Before radiation 
 
☐ During radiation 
 
☐ After radiation 
 
Radiation Treatment:  Start Date: __/__/____ End Date: __/__/____ 
Body Area Treated  
Total Dose: _____________ (Gy) 
 
Total Number of Treatments: _____________ 
On therapeutic clinical trial: 
☐ Yes  
☐ No   
 
 
 
 
 
Optional free text box for details 
Optional free text box for details 
Optional free text box for details 
Optional free text box for details 
Optional free text box for details 
 
 

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Treatment Course and Side Effects 
Did the patient complete treatment as planned? 
☐ Yes  
☐ No, due to toxicity  
☐ No, due to cancer progression 
☐ Other 
 
 
  
Treatment interruptions: 
☐Yes  
☐No   
 
 
 
 
Side effects during and at the end of treatment:  
 
 
 
 
Possible side effects which may occur later: 
 
 
 
 
 
Survivorship 
The following two sections include health concerns and lifestyle/behavior changes that the Primary Care 
Provider should discuss with the patient based on your recommendation. Check all that apply. 
 
Please discuss the following concerns with your patient: 
☐ Emotional and Mental Health 
☐ Fatigue   
☐ Weight changes 
 
☐ Physical functioning  
☐ Insurance   ☐ Work/School 
 
☐ Parenting 
☐ Financial Assistance  
☐ Fertility   
☐ Sexual functioning ☐ Memory loss 
☐ Other ______________________________________________________________________ 
 
Please discuss these lifestyle/behavior changes with your patient to improve his overall health: 
☐ Smoking/tobacco cessation  
☐ Healthy diet   
☐ Physical activity 
 
☐ Weight management (gain/loss)   
☐ Alcohol use   
☐ Sunscreen use 
  
☐ Other ______________________________________________________________________ 
Next appointment: 
☐ With Radiation Oncologist, in____weeks/months 
☐ None or only as needed with Radiation Oncologist 
 
☐ With other provider(s)  
 
☐ Follow-up testing  
 
 
Instructions given to patient (optional):  
 
 
 
Additional Details for a Radiation Completion Note 
Optional free text box for details 
 
Free text box for details on side effects and management (interventions, medications) 
 
Optional free text box for details 
Free text box for details on side effects and when to seek medical care 
 
Free text  
 
Free text  
 
Optional free text box for details 

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Prior radiation therapy (any site): 
 
☐ Yes  
☐ No   
 
 
On clinical trial: 
☐ Yes  
☐ No   
 
 
External beam and stereotactic radiotherapy treatments: 
 
Treatment  
site 
Treatment 
technique 
/ Modality 
Dose 
per 
fraction 
Total 
number 
of 
fractions 
Total 
dose 
Start 
Date 
End Date Fractions 
per day 
Fractions 
per week 
e.g. Site 1 
_/_/__ 
_/_/__ 
e.g. Site 2 
 
 
 
 
 
 
 
 
Total 
 
 
 
 
 
 
 
 
 
Special technical considerations: details to be included here can include (as relevant) 4D techniques, 
image guidance/gating, simulation technique, image fusion during planning, prescription point, etc. 
 
Brachytherapy treatments: 
 
Treatment  
site 
Treatment 
technique 
(LDR/ 
HDR/other) 
Isotope 
Dose 
per 
fraction 
Total 
number 
of 
fractions 
Total 
dose 
Start 
Date 
End 
Date 
Fractions 
per week 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Applicator used (for HDR only): _____________ 
 
Special technical considerations: details to be included here can include (as relevant) simulation 
technique, image fusion during planning, prescription point, etc. 
 
 
Person completing this form: 
 
Role:  ☐ Physician 
☐ Physician assistant ☐ Nurse 
☐ Nurse Practitioner 
 
Name:______________________________________________ 
 
Optional free text box for details 
 

NRG-CC007CD 
42 
NCI Version Date: March 24, 2021  
Androgen Deprivation Therapy (ADT) 
 
How it works: ADT works by lowering the amount of testosterone (the hormone that makes prostate 
cancer cells grow).  
 
How ADT is given: Usually as an injection into the buttock muscle or under the skin of your abdomen. 
 
Possible Side Effects of ADT 
 
Hot flashes 
• 
Feeling waves of heat in the face, head, upper body; night sweats may interfere with sleep. 
 
Diabetes 
• 
ADT increases the risk of type 2 (adult) diabetes 
• 
Men who have diabetes before starting ADT may find that medication alone isn’t enough to control 
diabetes.  
 
Heart health 
• 
Men on ADT can experience higher blood pressure, blood sugar, and other factors that raise the chance 
of having heart problems. 
• 
Make an appointment with your primary care doctor within 12 months to check your numbers: 
blood sugar, cholesterol levels, blood pressure. 
• 
Based on American Heart Association recommendations, you also need to have your primary care 
doctor check these (blood sugar, cholesterol levels, blood pressure) every year. 
 
Possible Side Effects of Radiation Therapy 
 
Bladder problems 
• 
Needing to go urgently or frequently 
• 
Burning sensation 
• 
Slower urine flow 
 
Bowel problems 
• 
Loose stools 
• 
Blood in stool 
 
Erectile dysfunction 
 
Cancer Monitoring 
 
You need to have a checkup with your radiation oncologist every 6 months.