Prostate Cancer - Comparative Outcomes of New Conceptual Paradigms for Treatment
Conditions: Prostate Cancer
Sponsor: Weill Medical College of Cornell University

 
 
 
Document: Protocol and Statistical Analysis Plan  
Official Study Title: Prostate Cancer – Comparative Outcomes of New Conceptual 
Paradigms for Treatment 
NCT #: 04890314 
IRB Protocol #: 20-08022531 
Document Date: Sep 13, 2021 

 
i 
 
TITLE:  Prostate Cancer Comparative Outcomes of New Conceptual Paradigms for 
Treatment 
 
IRB Protocol #: 20-08022531 
 
Version Date: 13Sep2021 
 
Funding Source: Patient-Centered Outcomes Research Institute (PCORI) 
 
Principal Investigator: 
 
Jim C. Hu, MD MPH 
 
 
Weill Cornell Medicine 
525 E. 68th Street, Starr 946 
New York, NY 10065 
Phone: 646-962-9600 
Fax: 646-962-0715 
 
Jch9011@med.cornell.edu 
 
Ronald C. Chen, MD MPH 
 
 
University of Kansas 
4001 Rainbow Blvd, MS 4033 
Kansas City, KS 66160 
Phone: 913-588-3612  
Rchen2@kumc.edu  
 
Co-Investigators: 
 
Ann S. Hamilton, PhD 
University of Southern California 
2001 N. Soto Street, SSB 318E 
Los Angeles, CA 90033 
Phone: 323-865-0434 
ahamilt@med.usc.edu  
 
Maria Schymura, PhD 
New York State Department of Health 
150 Broadway, Suite 361 
Albany, NY 11204 
Phone: 518-474-2255 
Maria.schymura@health.ny.gov  
 
Statistician: 
 
Andrew J. Vickers, PhD  
 
 
 
 
 
Memorial Sloan Kettering Cancer Center 
 
 
485 Lexington Ave, 2nd Floor 
 
 
New York, NY 10017 
 
 
Phone: 646-888-8233 
 
 
vickersa@mskcc.org 
 
 

 
ii 
Table of Contents 
List of Abbreviations ....................................................................................................................................... iv 
1. Protocol Summary ........................................................................................................................................ 1 
1. Study Objectives .................................................................................................................................................. 2 
1.1. Objectives ...................................................................................................................................................... 2 
1.2 Hypotheses / Research Questions ............................................................................................................. 2 
2. Background and Significance ..................................................................................................................... 3 
3. Study Design and Methods .......................................................................................................................... 3 
3.1 Overall Design .................................................................................................................................................... 3 
3.2 Patient Questionnaires – Refer to Appendix A. ............................................................................................. 3 
4. Study Enrollment .......................................................................................................................................... 4 
4.1 Study Population ................................................................................................................................................ 4 
4.2 Inclusion Criteria ................................................................................................................................................ 4 
4.3 Exclusion Criteria ............................................................................................................................................... 4 
4.4 Recruitment and Retention ............................................................................................................................... 4 
6. Study Procedures ......................................................................................................................................... 5 
6.1 Schedule of Trial Events ................................................................................................................................... 5 
7. Data Reporting / Regulatory Considerations ............................................................................................ 5 
7.1 Institutional Review Board/Ethics Committee Approval .......................................................................... 6 
7.2. Ethical Conduct of the Study ...................................................................................................................... 6 
7.3 Informed Consent .......................................................................................................................................... 6 
7.4 Compliance with Trial Registration and Results Posting Requirements ............................................... 7 
7.5 Record Retention .......................................................................................................................................... 7 
8. Statistical Considerations ............................................................................................................................ 7 
APPENDIX A....................................................................................................................................................... 9 
Baseline Survey ........................................................................................................................................................ 9 
First Follow Up Survey ........................................................................................................................................... 17 
Second Follow Up Survey ..................................................................................................................................... 28 
 
 
 

 
iii 
 
Confidentiality Statement 
 
This document is confidential and is to be distributed for review only to investigators, potential 
investigators, consultants, study staff, and applicable independent ethics committees or 
institutional review boards. The contents of this document shall not be disclosed to others without 
written authorization from WCM. 
 
 
 
 
 
 
 
 
_________________________________________________________________ 
Institution Name 
 
 
 
 
 
 
_________________________       __________________________        __________________ 
Principal Investigator’s Name      Principal Investigator’s Signature    Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
iv 
List of Abbreviations 
 
 
 
AE 
Adverse Event 
AS 
Active surveillance 
BMI 
Body Mass Index 
CER 
Comparative Effectiveness Research 
CFR 
Code of Federal Regulations 
CI 
Confidence interval 
CRF 
Case Report Form 
CTSC 
Clinical Translational Science Center  
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HRQOL 
Health Related Quality of Life 
ICF 
Informed Consent Form 
IMRT 
Intensity Modulated Radiation Therapy 
IRB 
Institutional Review Board 
NCCN 
National Comprehensive Cancer Network 
NYS 
New York State 
PCORI 
Patient-Centered Outcomes Research Institute 
PC-CONCEPT 
Prostate Cancer Comparative Outcomes of New Conceptual 
Paradigms for Treatment 
PGA 
Partial Gland Ablation 
PHI 
Protected Health Information 
PI 
Principal Investigator 
PSA 
Prostate-specific antigen 
REDCap 
Research Electronic Data Capture 
RP 
Radical Prostatectomy 
SAC 
Study Advisory Committee 
SBRT 
Stereotactic Body Radiation Therapy 
SCa 
Southern California 
SEER 
Surveillance Epidemiology and End Results 
WCM 
Weill Cornell Medicine 
 
 

 
1 
1. Protocol Summary 
 
 
Full Title:  
 
 
 
Prostate Cancer Comparative Outcomes of New Conceptual 
Paradigms for Treatment 
 
Short Title: 
 
 
 
PC CONCEPT  
 
Principal Investigators:  
Jim C. Hu, MD MPH; Ronald C. Chen, MD MPH 
 
Study Description:   
This study will use a population-based cohort design to study men 
with newly diagnosed low- and intermediate-risk prostate cancer 
at high-volume centers in Southern California (SCa) and New 
York State (NYS). Complications of contemporary treatments for 
prostate cancer and quality of life outcomes, such as general 
health, urinary, sexual, and bowel function, cancer anxiety, and 
treatment regret will be compared and tracked over the course of 
this study. 
 
Sample Size: 
 
N= 3,657 
 
Enrollment: 
 
This study will enroll 2,378 subjects and screen up to 3,657 
subjects.   
 
Study Population: 
 
Subjects will have pathologically-confirmed clinically localized 
prostate adenocarcinoma with National Comprehensive Cancer 
Network (NCCN) low (T1-T2a, Gleason 6, Grade Group 1, PSA 
<10 ng/mL) or intermediate risk (T2b-T2c or, Gleason 7, Grade 
Group 2 or 3 or PSA 10-20 ng/mL) at one of the selected hospitals 
in SCa and NYS. Subjects must also have a diagnosis date during 
the 18-month recruitment window. 
 
Enrollment Period:  
18 months 
 
Study Design: 
 
Prospective, observational  
 
Description of Sites   
Patient enrollment at 15 sites within SCa and NYS, identified 
through National Cancer Institute-sponsored Surveillance 
Epidemiology and End Results (SEER) 
 
Study Duration: 
 
01Oct2020 - 30Nov2023 
 
Participant Duration: 
12 months 
 
 
Primary Objectives: 
To measure the self-reported, overall and disease specific health 
related quality of life (HRQOL) prior to treatment, at 8 months, and 
12 months following active surveillance (AS), SBRT, IMRT, PGA, 
and RP. 

 
2 
 
 
To define and compare the rate of adverse events following 
stereotactic body radiation therapy (SBRT), partial gland ablation 
(PGA), intensity modulated radiation therapy (IMRT) and radical 
prostatectomy (RP) among men recently diagnosed with low and 
intermediate risk prostate cancer. 
 
Primary Endpoints: 
Change from Baseline in Patient-Reported Quality of Life as 
Measured on EQ-5D-5L at 8 Months & 12 Months following 
Treatment 
 
Change from Baseline in Patient-Reported Urinary, Sexual, and 
Bowel Function as Measured on EPIC-26 at 8 Months & 12 
Months following Treatment 
 
Change from Baseline in Ejaculatory Function as Measured on 
MSHQ-EjD at 8 Months & 12 Months following Treatment 
 
Change from Baseline in Patient-Reported Anxiety as Measured 
on MAX-PC at 8 Months & 12 Months following Treatment 
 
Assessment of Treatment Regret as Measured on Clark’s 
Prostate Cancer Health Worry at 8 Months & 12 Months following 
Treatment 
 
Assessment of Adverse Events at 8 Months & 12 Months following 
Treatment by CTCAE v5.0 
 
Assessment of Cancer Recurrence at 8 Months & 12 Months 
following Treatment by Patient Medical Records 
 
 
 
1. Study Objectives 
 
 
To compare complications of contemporary treatments for prostate cancer and quality of life 
outcomes in men with newly diagnosed low- and intermediate-risk prostate cancer through a 
prospective, population-based cohort study design. 
 
1.1. Objectives 
 
 
To measure the self-reported, overall and disease specific health related quality of life (HRQOL) 
prior to treatment, at 8 months, and 12 months following active surveillance (AS), SBRT, IMRT, 
PGA, and RP. 
To define and compare the rate of adverse events following stereotactic body radiation therapy 
(SBRT), partial gland ablation (PGA), intensity modulated radiation therapy (IMRT) and radical 
prostatectomy (RP) among men recently diagnosed with low and intermediate risk prostate 
cancer. 
 
 
1.2 Hypotheses / Research Questions 
 
 
 
PGA is associated with less reduction of urinary and sexual function compared to before 
treatment than both RP and IMRT. SBRT is associated with less reduction of urinary and sexual 

 
3 
function before treatment compared to RP and IMRT.  SBRT will be associated with less 
reduction in bowel function compared to IMRT. PGA is associated with better overall quality of 
life at 12 months compared to AS. 
 
PGA and SBRT are associated with fewer adverse events compared to RP and IMRT. 
 
2. Background and Significance 
 
Prostate cancer remains the most commonly diagnosed, solid organ tumor and the second most 
common cause of cancer death in U.S. men. Technological advances have enabled new 
treatment options, such as stereotactic body radiation therapy (SBRT) and partial gland ablation 
(PGA). Although heavily marketed as more convenient with fewer side effects, there is an 
absence of high-level, comparative effective research (CER) to discern relative outcomes to 
traditional therapies such as active surveillance (AS), radical prostatectomy (RP) and intensity 
modulated radiation therapy (IMRT). 
 
We will conduct a pragmatic, population-based cohort study of men with newly diagnosed low 
and intermediate risk prostate cancer in Southern California (SCa) and New York State (NYS) 
Surveillance Epidemiology and End Results (SEER) regions to bridge the evidence gap 
concerning adverse events and patient reported outcomes. Our proposed study will inform 
multiple stakeholders, who contributed to our study design. This includes prostate cancer 
survivors, payers, medical device manufacturers, professional organizations, community and 
academic prostate cancer experts and the Food and Drug Administration (FDA). 
 
3. Study Design and Methods 
 
3.1 Overall Design 
 
We will conduct rapid case ascertainment (within 3 weeks of diagnosis or sooner) at hospitals 
within these National Cancer Institute-sponsored Surveillance Epidemiology and End Results 
(SEER) Regions where PGA and SBRT are more likely to be offered. Cases will be identified 
through the SEER registries’ rapid case ascertainment system, and patients will be enrolled to 
the cohort study directly by the investigator team (not through the individual hospitals). At the 
time of rapid case ascertainment, the type of treatment a man receives is not yet known; 
therefore, we will enroll all patients diagnosed with low and intermediate-risk prostate cancer. 
 
3.2 Patient Questionnaires – Refer to Appendix A. 
 
A.  Administration 
▪ 
Timing and Frequency – Baseline questionnaires will be sent to eligible participants for 
study enrollment. Follow-up questionnaires at 8 months and 12 months will be sent to 
enrolled participants to ascertain treatment choice and obtain patient-reported outcomes 
following treatment.  
 
▪ 
Survey method 
Eligible participants will be mailed a survey packet consisting of a paper copy of the 
survey, an introductory letter and information sheet, and a postage paid return envelope. 
In the letter the participant will be informed that, if he wishes, he may also complete the 
survey online and will be given a code and link to the online survey. All materials will be 
provided in Spanish and English to those participants with Spanish surnames. 
Interviewers contacting the men are bilingual.   
 
A modified Dillman method will be used to increase response. This includes follow-up 
with telephone, mail, and offers of completion of the survey online or by telephone. 

 
4 
Specifically, if no response is received after 2 weeks, the study staff will telephone the 
participant to determine if he has any questions or concerns and to encourage him to 
complete the survey. At least 5 calls will be made on different days, times of the day 
(including evenings), and on weekends to reach the person. Additional follow-up efforts 
will include sending reminder postcards, re-mailing of the survey packet, sending a 
reminder letter with the link to the online survey, or offering to do the interview over the 
telephone. 
 
▪ 
Person Identifiers 
Patient identifiers obtained at the time of rapid case ascertainment will be used to link to 
the completed registry abstract. The registry variables to be linked to the cases will 
include: patient demographic data (age, date of birth, race, socio-economic status, 
quintile of census block of residence, marital status, birthplace), tumor data (PSA, stage, 
histology, grade, clinical and pathologic Gleason score, extension), treatment data 
(surgical code, radiation (type), dates of treatments, chemotherapy, and hormone 
therapy, PGA and AS). 
B. Study Instruments – Refer to Appendix A. 
4. Study Enrollment 
 
4.1 Study Population 
 
Subjects with a diagnosis of prostate cancer who meet the inclusion and exclusion criteria will 
be eligible for participation in this study.   
 
4.2 Inclusion Criteria 
 
To be included in the study, the participant will: (1) have pathologically-confirmed clinically 
localized prostate adenocarcinoma with Grade Group 1-2 (Gleason score 6 & 7)72 at one of the 
selected hospitals in SCa and NYS; (2) have a diagnosis date during the 18 month recruitment 
window; (3) speak either English or Spanish and; 4) agree to participate by completing the 
baseline questionnaire.  
4.3 Exclusion Criteria  
 
 
 
Patients will be excluded if they: 1) have clinically metastatic disease or high-risk PCa (T3a-T4, 
Gleason Grade Group 4 or 5 or PSA >20 ng/mL; (2) do not speak English or Spanish; or (3) are 
unwilling or unable (low literacy, too ill, etc.) to give informed consent; or (4) are diagnosed with 
prostate cancer incidentally at the time of radical cysto-prostatectomy to treat bladder cancer. 
 
4.4 Recruitment and Retention 
 
 
We will conduct rapid case ascertainment (within usually 4 weeks of diagnosis or sooner) at 
hospitals within these SEER Regions where PGA and SBRT are more likely to be offered in 
order to maximize the sample size of men receiving these new treatments. 
 
The SCa and NYS SEER registries are mandated by their respective states to routinely collect 
and report information on all cancers diagnosed in their catchment areas, including 
sociodemographic information and tumor characteristics, such as final pathologic stage and 
histologic grade. Active and passive follow-up is also conducted to ascertain vital status and 
underlying cause of death. 
 

 
5 
The Study Advisory Committee (SAC) is comprised of patient partners Fans for the Cure and Us 
TOO, a senior FDA officer, and a representative from Centers for Medicare and Medicaid 
Services. Patient partners will participate actively in research decision-making through monthly 
SAC meetings. Patient partners will co-lead to troubleshoot challenges that may arise in subject 
recruitment, review preliminary outcomes, troubleshoot research obstacles and participate in 
dissemination of study findings. Patient partners will resolve potentially confusing and/or missing 
survey responses. 
 
6. Study Procedures 
 
6.1 Schedule of Trial Events 
Data elements 
Baseline  
8 
months 
12 
months 
Patient reported 
 
 
 
Income 
X 
 
 
Education 
X 
 
 
Family history of prostate cancer 
X 
 
 
Employment status 
X 
X 
X 
Charlson co-morbidity  
X 
X 
X 
Height 
X 
X 
X 
Weight 
X 
X 
X 
Medications 
X 
X 
X 
Treatment (confirm PGA and SBRT) 
 
 
 
Cancer recurrence 
 
X 
X 
Secondary treatment(s) 
 
X 
X 
Adverse events 
 
X 
X 
Patient reported outcomes 
X 
X 
X 
Registry reported 
 
 
 
Age 
X 
 
 
Race 
X 
 
 
Marital status 
X 
 
 
Insurance type 
X 
 
 
Poverty level based on census tract 
X 
 
 
PSA 
X 
 
 
Biopsy pathology 
X 
 
 
Clinical stage 
X 
 
 
Treatment  
X 
 
 
 
 
 
7. Data Reporting / Regulatory Considerations 
 
The SCa and NYS SEER research teams will independently contact participants, collect data 
and enter survey results in a unified study database maintained at USC. A Study ID will be 
created for each case and survey and registry data will be linked to it, and no personal 
identifiers (or registry IDs) will be included in the analytic dataset. Only staff directly involved 
with the study at each site will have access to the tracking systems.  In addition, a central 
database will be maintained at Weill Cornell to assess the overall progress of the project. Each 
site will maintain a local password-protected and secure linkage database containing participant 
protected health information and identifiers and the linkage to the Study ID number.  This 
database will only be accessible to researchers at the local site where the participant is 
followed.  Participants will return their questionnaires to the local investigators.  Accordingly, 
local study staff will go over each completed questionnaire and check all coding (although the 
questionnaire will be designed to be self-coded when possible). 

 
6 
 
7.1 Institutional Review Board/Ethics Committee Approval  
 
As required by local regulations, the Investigator will ensure all legal aspects are covered, and 
approval of the appropriate regulatory bodies obtained, before study initiation.  
Before initiation of the study at each study center, the protocol, the ICF, other written material 
given to the patients, and any other relevant study documentation will be submitted to the 
appropriate Ethics Committee. Written approval of the study and all relevant study information 
must be obtained before the study center can be initiated. Any necessary extensions or renewals 
of IEC/IRB approval must be obtained for changes to the study, such as amendments to the 
protocol, the ICF, or other study documentation. The written approval of the IEC/IRB together with 
the approved ICF must be filed in the study files.  
The Investigator will report promptly to the IEC/IRB any new information that may adversely affect 
the safety of the subjects or the conduct of the study. The Investigator will submit written 
summaries of the study status to the IEC/IRB as required. On completion of the study, the IEC/IRB 
will be notified that the study has ended.  
 
All agreed protocol amendments will be clearly recorded on a protocol amendment form and will 
be signed and dated by the original protocol approving signatories. All protocol amendments will 
be submitted to the relevant institutional IEC/IRB for approval before implementation, as required 
by local regulations. The only exception will be when the amendment is necessary to eliminate 
an immediate hazard to the trial participants. In this case, the necessary action will be taken first, 
with the relevant protocol amendment following shortly thereafter.  
Once protocol amendments or consent form modifications are implemented at the lead site, Weill 
Cornell Medicine, updated documents will be provided to participating sites. Weill Cornell 
Medicine must approve all consent form changes prior to local IRB submission.  
Relevant study documentation will be submitted to the regulatory authorities of the participating 
countries, according to local/national requirements, for review and approval before the beginning 
of the study. On completion of the study, the regulatory authorities will be notified that the study 
has ended.  
 
7.2. Ethical Conduct of the Study  
The Investigators and all parties involved should conduct this study in adherence to the ethical 
principles based on the Declaration of Helsinki, GCP, ICH guidelines and the applicable national 
and local laws and regulatory requirements.  
 
This study will be conducted under a protocol reviewed and approved by the applicable ethics 
committees and investigations will be undertaken by scientifically and medically qualified persons, 
where the benefits of the study are in proportion to the risks. 
 
7.3 Informed Consent 
 
The investigator or qualified designee must obtain documented consent according to ICH-GCP 
and local regulations, as applicable, from each potential subject or each subject’s legally 
authorized representative prior to participating in the research study. Subjects who agree to 
participate will sign the approved informed consent form and will be provided a copy of the signed 
document.   
 
The initial ICF, any subsequent revised written ICF and any written information provided to the 
subject must approved by IRB prior to use. The ICF will adhere to IRB/IEC requirements, 

 
7 
applicable laws and regulations. 
 
7.4 Compliance with Trial Registration and Results Posting Requirements  
 
Under the terms of the Food and Drug Administration Modernization Act (FDAMA) and the Food 
and Drug Administration Amendments Act (FDAAA), the Sponsor-Investigator of the trial is solely 
responsible for determining whether the trial and its results are subject to the requirements for 
submission to http://www.clinicaltrials.gov. Information posted will allow subjects to identify 
potentially appropriate trials for their disease conditions and pursue participation by calling a 
central contact number for further information on appropriate trial locations and trial site contact 
information. 
 
7.5 Record Retention 
 
Essential documents are those documents that individually and collectively permit evaluation of 
the study and quality of the data produced.  After completion of the study, all documents and data 
relating to the study will be kept in an orderly manner by the Investigator in a secure study file.  All 
subject medical records and other source documentation will be kept for the maximum time 
permitted by the hospital, institution, or medical practice.   
 
8. Statistical Considerations 
 
The data structure for the patient reported outcomes is longitudinal, and data could be missing 
at certain time points (e.g. a patient provides data at 8 but not 12 months). We will use a general 
estimating equations approach using a Gaussian link-function and auto-regressive correlation. 
The covariates will adjust for adverse events (prostate cancer aggressiveness [low or 
intermediate risk], age [continuous], race [white, black, other], comorbidity score [Charlson 
Index]) plus baseline disease-specific HRQOL score; treatment group will be entered as four 
separate variables (e.g. PGA 1 or 0; RP 1 or 0; SBRT 1 or 0; IMRT 1 or 0) with AS as the 
reference group.  
 
Because differences between groups will vary by time (e.g. large decreases in urinary function 
in the surgery group at month 8, smaller by month 12), we will include a time by treatment 
interaction term. This model provides adjusted differences from AS over time for each 
treatment, along with a 95% CI and a p-value. From these estimates, it is straightforward to 
conduct pairwise comparisons (e.g. sexual function between PGA and surgery). As a sensitivity 
analysis, we will use propensity scores as the covariate as described above, again excluding 
patients at the extremes of the propensity distribution.  
 
Adverse events will be treated as binary variables, defined as present or absent, with the 
severity being characterized by the associated categorical response. Mild AEs (grade 1) will be 
excluded because it typically resolves without intervention. However, inclusion of mild AEs will 
be considered in sensitivity analysis. Type and severity of AEs will be described separately by 
treatment.  
 
The analysis will be by binomial logistic regression. The covariates will be age (continuous), BMI 
(using restricted cubic splines with knots at 30 and 35), comorbidity score (Charlson index), 
clinical stage (T1c or T2a, T2b, T2c, T3/4), NCCN risk group and pretreatment PSA (CI-5). 
Treatment group will be entered as 3 separate variables (i.e. PGA 1 or 0; SBRT 1 or 0; IMRT 1 
or 0) with surgery as the reference group. 
 
We will also conduct a sensitivity analysis using propensity methods – where propensity for 
treatment is derived from a multinomial logistic regression with the same covariates as above – 
and excluding any patient with >95% or <15% chance of receiving any of the treatments.  

 
8 
 
For adverse events, we expect a rate of 10% in the IMRT and RP arms. The main HRQOL 
endpoint of interest is EPIC-26 sexual function. The estimated number of patients we will 
evaluate is as follows: AS 300; PGA: 280; SBRT: 288; IMRT: 316; RP: 333. This is based on the 
incidence of low and intermediate prostate cancer in the SCa and NYS SEER registries. 
 
 

 
9 
APPENDIX A. 
 
Baseline Survey 
 
1. Today’s date: 
__ __ / __ __ / 2 0 __ __ 
M  M    D  D     Y  Y  Y  Y 
 
2. What is your birth date: 
__ __ / __ __ / 19__ __ 
M  M     D  D     Y  Y  Y  Y 
 
3. When were you first diagnosed with prostate cancer: 
__ __ / __ __ / 2 0 __ __ 
M  M.    D  D     Y  Y  Y  Y 
 
4. In general, you would say your health is: 
 Excellent 
 Very good 
 Good 
 Fair 
 Poor 
 Very poor 
 
5. What is your most recent PSA result?    __ __ . __ __  
 
 Don’t know 
 
6. What date was this PSA test done?  
 __ __ / __ __ / 2 0 __ __  Don’t know 
M  M 
D  D    Y  Y  Y  Y 
 
 
 
7. This next question is about your plans for treatment for prostate cancer or treatment you 
have already received.  
 
For each of the following types of treatment, please indicate if you have chosen it, started 
to receive it, are considering it, or are not considering it at this time. Check one box on 
each row that best reflects your decision at this time for each type of treatment. 
 
 
Type of Treatment 
I have chosen 
this plan and 
have started or 
completed it 
I have 
chosen this 
plan but 
have not yet 
received it 
I am 
considering 
this option but 
have not made 
a decision yet 
I am not 
considering 
this option 
at this time 
a. Active Surveillance 
(My doctor will monitor 
how I am doing without 
directly treating the 
cancer) 
 
Date started: 
 __ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
 
 
 
 
 
 
Type of Treatment 
(Cont.) 
I have chosen 
this plan and 
have started or 
I have 
chosen this 
plan but 
I am 
considering 
this option but 
I am not 
considering 
this option 

 
10 
completed it 
have not yet 
received it 
have not made 
a decision yet 
b. Prostate surgery 
(radical 
prostatectomy), which 
would remove the 
whole prostate.  
 
Date of surgery: 
 __ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
 
 
 
 
 
 
c. HIFU / High Intensity 
Focused Ultrasound 
(ultrasound waves 
cross tissue to destroy 
the part of the prostate 
that had cancer) 
 
Date started: 
 __ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
 
 
 
 
 
 
d. Cryotherapy (freezing 
the part of the prostate 
that had cancer) 
 
Date started: 
 __ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
 
 
 
 
 
 
e. Laser therapy 
 
Date started: 
 __ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
 
 
 
 
 
 
f. Radio Frequency 
Ablation 
 
Date started: 
 __ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
 
 
 
 
 
 
g. Photodynamic 
therapy 
 
Date started: 
 __ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
 
 
 
 
 
 
 
h. External Beam 
Radiation Therapy or 
IMRT (radiation 
treatment requiring 
more than 2 weeks of 
treatment) 
 
Date started: 
 __ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
 
 
 
 
 
 
 
i. Stereotactic Body 
Radiation Therapy 
(SBRT) (radiation 
treatment requiring 
less than 2 weeks of 
treatment) 
 
Date started: 
 __ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
 
 
 
 
 

 
11 
j. Brachytherapy 
(radioactive seeds) 
This involves having 
radioactive seeds 
placed within the 
prostate 
 
Date started: 
 __ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
 
 
 
 
 
k. Proton Beam 
Therapy 
 
Date started: 
 __ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
 
 
 
 
 
 
l. Any other type of 
radiation therapy? 
Describe:__________ 
_________________ 
 
Date started: 
 __ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
 
 
 
 
 
m. Hormonal treatments 
to lower testosterone 
(e.g. Lupron, Zoladex, 
Firmagon, Eligard, 
Vantas, etc) 
 
Date started: 
 __ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
 
 
 
 
 
 
n. Surgical removal of 
testicles 
(Orchiectomy) 
 
Date of surgery: 
 __ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
 
 
 
 
 
 
o. Chemotherapy 
(docetaxel, 
cabazitaxel, other) 
 
Date started: 
 __ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Health Before Treatment 
For the next set of questions, please refer to the time just BEFORE you were diagnosed.  
Urinary Issues 
8. During the 4 weeks before your diagnosis, how often have you leaked urine (pee)? (Choose one) 

 
12 
 More than once a day 
 About once a day 
 More than once a week 
 About once a week 
 Rarely or never 
9. Which of the following best describes your urinary control (ability to hold pee) during the 4 weeks before your 
diagnosis? (Choose one) 
 No urinary control whatsoever 
 Frequent dribbling 
 Occasional dribbling 
 Total control 
10. How many pads or adult diapers per day did you usually use to control leakage (pee) during the 4 weeks 
before your diagnosis? (Choose one) 
 None 
 1 pad per day 
 2 pads per day 
 3 or more pads per day 
11. How big a problem, if any, has each of the following been for you during the 4 weeks before your diagnosis? 
(Choose one for each item) 
 
 
No 
problem 
Very 
small 
problem 
Small 
problem 
Moderate 
problem 
Big 
problem 
a. Dripping or leaking urine 
(pee) 
 
 
 
 
 
b. Pain or burning on urination 
(when peeing) 
 
 
 
 
 
c. Bleeding with urination (pee) 
 
 
 
 
 
d. Weak urine stream (pee) or 
incomplete emptying 
 
 
 
 
 
e. Need to urinate (pee) 
frequently during the day 
 
 
 
 
 
 
 
 
 
 
12. Overall, how big a problem has your urinary function (ability to pee) been for you during the 4 weeks before 
your diagnosis? (Choose one) 
 No problem 
 Very small problem 
 Small problem 
 Moderate problem 

 
13 
 Big problem 
 
Bowel Issues 
13. How big a problem, if any, has each of the following been for you during the 4 weeks before your diagnosis? 
(Choose one response on each line) 
 
 
No 
problem 
Very 
small 
problem 
Small 
problem 
Moderate 
problem 
Big 
problem 
a. Urgency to have a bowel 
movement (poop) 
 
 
 
 
 
b. Increased frequency of 
bowel movements (poop) 
 
 
 
 
 
c. Losing control of your stools 
(poop) 
 
 
 
 
 
d. Bloody stools (blood with 
poop) 
 
 
 
 
 
e. Abdominal/pelvic/rectal pain 
 
 
 
 
 
 
14. Overall, how big a problem have your bowel habits (ability to poop) been for you during the 4 weeks before 
your diagnosis? (Choose one) 
 No problem 
 Very small problem 
 Small problem 
 Moderate problem 
 Big problem 
 
Sexual Issues 
 
15. How would you rate each of the following during the 4 weeks before your diagnosis?  
(Choose one response on each line) 
 
 
Very poor 
to none 
Poor 
Fair 
Good 
Very 
good 
a. Your ability to have an 
erection (hard on)? 
 
 
 
 
 
b. Your ability to reach orgasm 
(climax)? 
 
 
 
 
 
 
 
 
16. How would you describe the usual QUALITY of your erections (hard on) during the 4 weeks before your 
diagnosis? (Choose one) 
 None at all 
 Not firm enough for any sexual activity 

 
14 
 Firm enough for masturbation and foreplay only 
 Firm enough for intercourse 
 
17. How would you describe the FREQUENCY of your erections (hard on) during the 4 weeks before your 
diagnosis? (Choose one) 
 I NEVER had an erection when I wanted one 
 I had an erection LESS THAN HALF the time I wanted one 
 I had an erection ABOUT HALF the time I wanted one 
 I had an erection MORE THAN HALF the time I wanted one 
 I had an erection WHENEVER I wanted one 
 
18. Overall, how would you rate your ability to function sexually during the 4 weeks before your diagnosis? 
(Choose one) 
 Very poor 
 Poor 
 Fair 
 Good 
 Very good 
 
19. Overall, how big a problem has your sexual function, or lack of sexual function, been for you during the 4 weeks 
before your diagnosis? (Choose one) 
 No problem 
 Very small problem 
 Small problem 
 Moderate problem 
 Big problem 
20. How big a problem during the 4 weeks before your diagnosis was each of the following for you? (Choose one 
response on each line) 
 
 
No 
problem 
Very 
small 
problem 
Small 
problem 
Moderate 
problem 
Big 
problem 
a. Feeling depressed 
 
 
 
 
 
b. Lack of energy 
 
 
 
 
 
c. Change in body weight 
 
 
 
 
 
 
 
 
 
 
 
 
Demographic Questions 
21.  What is your ethnicity? 
 Hispanic or Latino 
 Not Hispanic or Latino 
 
 
 
22. What is your race? (Choose all that apply) 

 
15 
 White or Caucasian 
 Black or African-American 
 Asian 
 Native Hawaiian or Other Pacific Islander 
 Native American or Alaska Native 
 
 
 
23.  What is your current marital status? 
 Single or never married 
 Married or domestic partnership 
 Divorced 
 Widowed 
 Separated 
 
 
 
24. What is your current employment status? 
 Working full time 
 Working part time 
 Retired 
 Unemployed or looking for work 
 On disability 
 
25. What is the HIGHEST level of education you have completed?  
 Grade school or less 
 Some high school 
 High school graduate or GED 
 Vocational school 
 Some college 
 Associates degree 
 College graduate (Bachelor’s degree) 
 Some graduate education 
 Graduate degree 
 
 
 
 
 
26. What is the total income of your household? 
 Less than $10,000 
 $10,001 to $20,000 
 $20,001 to $40,000 
 $40,001 to $70,000 
 $70,001 to $90,000 
  More than $90,000 
 
27. What kind of health insurance or health care coverage do you currently have? (Check all that apply) 

 
16 
 Private insurance (please select type below): 
 Insurance provided through my current or former employer or union (including Kaiser/HMO/PPO) 
 Insurance provided by another family member (e.g., spouse) through their current or former employer or 
union (including Kaiser/HMO/PPO) 
 Insurance purchased directly from an insurance company (by you or another family member) 
 Insurance purchased from an exchange (sometimes called Obamacare or the Affordable Care Act) 
 Public or government insurance (please select type below): 
 Medicaid or other state provided insurance  
 Medicare/government insurance for age 65 years and older 
 Medicare Advantage 
 MediGAP 
 VA (including those who have ever used or enrolled for VA health care) 
 I do not have any medical insurance 
 
 

 
17 
First Follow Up Survey 
 
1. Today’s date:  
__ __ / __ __ / 2 0 __ __ 
M  M    D   D           Y   Y 
 
2. How tall are you? _____________ (feet, inches) 
 
3. What is your weight? _____________(pounds)  
 
4. Do you have any history of any of the following (check box if Yes)?: 
 
 Heart attack 
 
Liver disease: 
¨ Mild liver disease 
¨ Moderate or severe liver disease 
 
 Congestive heart failure 
 
 Peripheral vascular disease 
 
Diabetes: 
¨ Diabetes without chronic complications 
¨ Diabetes with chronic complications 
 Cerebrovascular disease 
 
 Hypertension 
 
 
 Chronic pulmonary disease 
 
 Hemiplegia or paraplegia 
 
 Rheumatologic disease 
 
 Renal disease 
 
 Peptic ulcer disease 
 
 Any other malignancy besides prostate cancer, 
including leukemia and lymphoma 
 
 
 
 
 Metastatic (non-prostate) solid tumor 
 
5. What was your last PSA value? (approximate value): 
  
.   
   ng/ml 
 
 Don’t know 
 
 
6. When was the date of your last PSA? (approximate date):   
/   
 
 
 
Month   Year 
 
 
 
 
 
 
 Don’t know 
 
 
 
 
 

 
18 
7. PSA: How true has each of the following statements been for you during the past 4 weeks? 
 
Choose one response on each line 
 
Not 
at all 
A little 
bit 
Somewhat 
Quite 
a bit 
Very 
much 
a. I keep close track of my PSA 
 
 
 
 
 
b. Knowing my PSA level is comforting to me 
 
 
 
 
 
c. I live in fear that my PSA will rise 
 
 
 
 
 
 
8. Since your initial treatment for prostate cancer, did your doctor ever tell you that your prostate cancer came back 
(recurred) or progressed (got worse)? 
 
 
 Yes 
 
 
 No 
 
9. Since you were diagnosed with prostate cancer, has a doctor ever told you that your prostate cancer had spread 
to other areas of your body? 
 
 
 Yes 
 
 
 No 
 
10. These next questions are about the treatments for prostate cancer that you have received.  
For each of the following types of treatment, please check the one(s) you have received and indicate the date you 
received it (or started it) 
 
Type of Treatment 
I have received this 
treatment 
Date received or 
started 
a. 
Active Surveillance (My doctor will monitor how 
I am doing without directly treating the cancer) 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
b. 
Prostate surgery (radical prostatectomy), 
which would remove the whole prostate.  
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
c. 
HIFU / High Intensity Focused Ultrasound 
(ultrasound waves cross tissue to destroy the 
part of the prostate that had cancer) 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
d. 
Cryotherapy (freezing the part of the prostate 
that had cancer) 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
e. 
Laser therapy 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
f. 
Radio Frequency Ablation 
 
 
 
 
 
 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
 
 
 
 

 
19 
 
Type of Treatment 
I have received this 
treatment 
Date received or 
started 
g. 
Photodynamic therapy 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
h. 
External Beam Radiation Therapy or IMRT 
(radiation treatment requiring more than 2 weeks 
of treatment) 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
i. 
Stereotactic Body Radiation Therapy (SBRT) 
(radiation treatment requiring less than 2 weeks 
of treatment) 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
j. 
Brachytherapy (radioactive seeds) This 
involves having radioactive seeds placed within 
the prostate 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
k. 
Proton Beam Therapy 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
l. 
Any other type of radiation therapy? 
Describe:___________________________ 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
m. Hormonal treatments to lower testosterone 
(e.g. Lupron, Zoladex, Firmagon, Eligard, 
Vantas, etc) 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
n. 
Surgical removal of testicles (Orchiectomy) 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
o. 
Chemotherapy (docetaxel, cabazitaxel, other) 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
 
 
 
 
If you have only received active surveillance or have not had any treatment yet for your prostate cancer, 
please skip to Question 16. 
11. As individuals go through treatment for cancer, they sometimes experience different symptoms and side effects. 
For each symptom below, please select the one response that best describes your experiences in the 7 days 
after your initial treatment choice (surgery, radiation, partial gland ablation).  
1) 
Symptom: Abdominal pain 
a. In the 7 days after your initial treatment, how often did you have pain in the abdomen (belly area)? 
 
Never 
 
Rarely 
 
Occasionally 
 
Frequently 
 
Almost constantly 
b. In the 7 days after your initial treatment, what was the severity of your pain in the abdomen (belly area) at its 
worst? 
 
None 
 
Mild 
 
Moderate 
 
Severe 
 
Very severe 

 
20 
c. In the 7 days after your initial treatment, how much did pain in the abdomen (belly area) interfere with your 
usual or daily activities? 
 
Not at all 
 
A little bit 
 
Somewhat 
 
Quite a bit 
 
Very much 
 
2) 
Symptom: Swelling 
a. In the 7 days after your initial treatment, how often did you have arm or leg swelling? 
 
Never 
 
Rarely 
 
Occasionally 
 
Frequently 
 
Almost constantly 
b. In the 7 days after your initial treatment, what was the severity of your arm or leg swelling at its worst? 
 
None 
 
Mild 
 
Moderate 
 
Severe 
 
Very severe 
c. In the 7 days after your initial treatment, how much did arm or leg swelling interfere with your usual or daily 
activities? 
 
Not at all 
 
A little bit 
 
Somewhat 
 
Quite a bit 
 
Very much 
3) 
Symptom: General pain 
a. In the 7 days after your initial treatment, how often did you have pain? 
 
Never 
 
Rarely 
 
Occasionally 
 
Frequently 
 
Almost constantly 
b. In the 7 days after your initial treatment, what was the severity of your pain at its worst? 
 
None 
 
Mild 
 
Moderate 
 
Severe 
 
Very severe 
c. In the 7 days after your initial treatment, how much did pain interfere with your usual or daily activities? 
 
Not at all 
 
A little bit 
 
Somewhat 
 
Quite a bit 
 
Very much 
 
4) 
Symptom: Fatigue 
a. In the 7 days after your initial treatment, what was the severity of your fatigue, tiredness, or lack of energy at 
its worst? 
 
None 
 
Mild 
 
Moderate 
 
Severe 
 
Very severe 
b. In the 7 days after your initial treatment, how much did fatigue, tiredness, or lack of energy interfere with 
your usual or daily activities? 
 
Not at all 
 
A little bit 
 
Somewhat 
 
Quite a bit 
 
Very much 
 
 
 
 
 
 

 
21 
12. Have you been hospitalized for complications from your prostate cancer treatment or for any other problems after 
receiving prostate cancer treatment? 
 
 Yes: 
a. What was the reason for the hospitalization? 
 
___________________________________________ 
       b. How many days did you spend in the hospital? ___ ___ 
 
 No 
 
13. Did you perform Kegel exercises after your prostate cancer treatment? 
 Yes--How often do you (did you) do Kegel exercises?  
 
 Once a week or less      
 Twice a week       
 More often than twice a week 
 No 
 I don’t know 
 
14. Did your doctor advise you to do Kegel exercises after your prostate cancer treatment? 
 Yes--What resources were given to you to help you do Kegel exercises? Check all that apply. 
 Verbal explanation 
 Handout 
 Visit with a Nurse Counselor 
 Referral to Physical Therapy 
 None 
 I don’t know 
 Other: __________________________________ 
 
 No 
 I don’t know 
 
15. Did you experience any (other) complication or unexpected outcome within 3 months after your prostate cancer 
treatment? 
 Yes: If yes, please describe: ________________________________________ 
 No 
 
Current Health 
 
16. In general, would you say your health is: 
 Excellent 
 Very good 
 Good 
 Fair 
 Poor 
 Very poor 
 
For the next set of questions, please think about your experience during the past 4 weeks. 
Urinary Issues 
17. In the past 4 weeks how often did you leak urine (pee)? (Choose one) 
 More than once a day 
 About once a day 
 More than once a week 
 About once a week 
 Rarely or never 

 
22 
18. Which of the following best describes your urinary control (ability to hold pee) during the past 4 weeks? 
(Choose one) 
 No urinary control whatsoever 
 Frequent dribbling 
 Occasional dribbling 
 Total control 
19. How many pads or adult diapers did you usually use per day to control urine (pee) leakage during the past 4 
weeks? (Choose one) 
 None 
 1 pad per day 
 2 pads per day 
 3 or more pads per day 
 
20. How big a problem, if any, was each of the following during the past 4 weeks? (Choose one for each item) 
 
 
No problem 
Very small 
problem 
Small 
problem 
Moderate 
problem 
Big 
problem 
a. 
Dripping or leaking urine (pee) 
 
 
 
 
 
b. 
Pain or burning on urination (when 
peeing) 
 
 
 
 
 
c. 
Bleeding with urination (when 
peeing) 
 
 
 
 
 
d. 
Weak urine stream (pee) or 
incomplete emptying 
 
 
 
 
 
e. 
Need to urinate (pee) frequently 
during the day 
 
 
 
 
 
 
21. Overall, how big a problem was your urinary function (ability to pee) for you during the past 4 weeks? (Choose 
one) 
 No problem 
 Very small problem 
 Small problem 
 Moderate problem 
 Big problem 
 
Bowel Issues 
22. How big a problem, if any, was each of the following during the past 4 weeks? (Choose one response on each 
line) 
 
 
No problem 
Very small 
problem 
Small 
problem 
Moderate 
problem 
Big 
problem 
a. 
Urgency to have a bowel 
movement (poop) 
 
 
 
 
 
b. 
Increased frequency of bowel 
movements (poop) 
 
 
 
 
 
c. 
Losing control of your stools (poop) 
 
 
 
 
 
d. 
Bloody stools (blood with poop) 
 
 
 
 
 
e. 
Abdominal/pelvic/rectal pain 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
23 
23. Overall, how big a problem were your bowel habits (ability to poop) during the past 4 weeks? (Choose one) 
 No problem 
 Very small problem 
 Small problem 
 Moderate problem 
 Big problem 
 
 
Sexual Issues 
24. Do you currently use any of the following to help with problems with sexual function? (Choose one response on 
each line) 
 
 
 
 
 
Yes 
No 
a. 
Vacuum suction device 
 
 
b. 
Penile injections (shots) 
 
 
c. 
Pills, such as Viagra, Cialis, Levitra, Staxyn, Stendra 
 
 
d. 
Urethral pellets or suppositories (Muse) 
 
 
e. 
Penile prosthesis (surgical implant) 
 
 
f. 
Other (please specify): _____________________________ 
 
 
 
 
25. How would you rate each of the following during the past 4 weeks?  
(Choose one response on each line) 
 
 
Very poor 
to none 
Poor 
Fair 
Good 
Very good 
a. 
Your ability to have an erection 
(getting hard for sex)? 
 
 
 
 
 
b. 
Your ability to reach orgasm 
(climax)? 
 
 
 
 
 
 
26. How would you describe the usual QUALITY of your erections (getting hard for sex) during the past 4 weeks? 
(Choose one) 
 None at all 
 Not firm enough for any sexual activity 
 Firm enough for masturbation and foreplay only 
 Firm enough for intercourse 
27. How would you describe the FREQUENCY of your erections (getting hard for sex) during the past 4 weeks? 
(Choose one) 
 I NEVER had an erection when I wanted one 
 I had an erection LESS THAN HALF the time I wanted one 
 I had an erection ABOUT HALF the time I wanted one 
 I had an erection MORE THAN HALF the time I wanted one 
 I had an erection WHENEVER I wanted one 
28. Overall, how would you rate your ability to function sexually during the past 4 weeks? (Choose one) 
 Very poor 
 Poor 
 Fair 
 Good 
 Very good 

 
24 
 
29. Overall, how big a problem was your sexual function, or lack of sexual function, for you during the past 4 
weeks? (Choose one) 
 No problem 
 Very small problem 
 Small problem 
 Moderate problem 
 Big problem 
30. How often have you been able to ejaculate or “cum” when having sexual activity? 
 All the time 
 Most of the time 
 About half the time 
 Less than half the time 
 None of the time / could not ejaculate 
 
31. How would you rate the strength or force of your ejaculation? 
 As strong as it always was 
 A little less strong than it used to be 
 Somewhat less strong than it used to be 
 Much less strong than it used to be 
 Very much less strong than it used to be 
 Could not ejaculate 
 
32. How would you rate the amount or volume of semen or fluid when you ejaculate? 
 As much as it always was 
 A little less than it used to be 
 Somewhat less than it used to be 
 Much less than it used to be 
 Very much less than it used to be 
 Could not ejaculate 
 
33. If you have had any ejaculation difficulties or have been unable to ejaculate, have you been bothered by this? 
 No problem with ejaculation 
 Not at all bothered 
 A little bothered 
 Moderately bothered 
 Very bothered 
 Extremely bothered 
 
34. How big a problem during the past 4 weeks was each of the following for you? (Choose one response on each 
line) 
 
 
No problem 
Very small 
problem 
Small 
problem 
Moderate 
problem 
Big 
problem 
a. 
Feeling depressed 
 
 
 
 
 
b. 
Lack of energy 
 
 
 
 
 
c. 
Change in body weight 
 
 
 
 
 
 
 
 

 
25 
For the next set of questions, indicate which best describes your health TODAY. 
 
35. Mark an X on the scale to indicate how your health is today. 
This scale is numbered from 0 to 100. 
100 means the best health you can imagine. 
0 means the worst health you can imagine. 
 
Please write the number you marked on the scale in the box: 
 
36. Mobility: 
 I have no problems walking 
 I have slight problems walking 
 I have moderate problems walking 
 I have severe problems walking 
 I am unable to walk 
 
37. Self-care: 
 I have no problems washing or dressing myself 
 I have slight problems washing or dressing myself 
 I have moderate problems washing or dressing myself 
 I have severe problems washing or dressing myself 
 I am unable to wash or dress myself 
 
38. Usual activities  
(e.g. work, study, housework, family or leisure activities): 
 I have no problems doing my usual activities 
 I have slight problems doing my usual activities 
 I have moderate problems doing my usual activities 
 I have severe problems doing my usual activities 
 I am unable to do my usual activities 
 
39. Pain / Discomfort: 
 I have no pain or discomfort 
 I have slight pain or discomfort 
 I have moderate pain or discomfort 
 I have severe pain or discomfort 
 I have extreme pain or discomfort 
40. Anxiety / Depression 
 I am not anxious or depressed 
 I am slightly anxious or depressed 
 I am moderately anxious or depressed 
 I am severely anxious or depressed 
 I am extremely anxious or depressed 
 
 
 
 
 
 
 
 
 
 
 
 

 
26 
Views Surrounding Impact of Prostate Cancer and Treatment Decision 
 
41. During the past four weeks, how much of the time have you wished that you could change your mind about the 
kind of treatment you chose for your prostate cancer? 
 All of the time 
 Most of the time 
 A good bit of the time 
 Some of the time 
 A little bit of the time 
 None of the time 
 
42. How true or false has the following statement been for you during the past four weeks: 
I feel that I would be better off if I had chosen the other treatment for prostate cancer. 
 Definitely true 
 Mostly true 
 Neither true nor false 
 Mostly false 
 Definitely false 
 
43. How true or false has the following statement been for you during the past four weeks: 
It bothers me that other men with prostate cancer get treatment that is very different from what I have received. 
 Definitely true 
 Mostly true 
 Neither true nor false 
 Mostly false 
 Definitely false 
 
44. Listed below are a number of statements concerning a person’s beliefs about their own health. During the past 
week, please indicate how much you agree or disagree with each statement. 
 
 
Strongly 
agree 
Agree 
Disagree 
Strongly 
Disagree 
a. 
Because cancer is unpredictable, I feel I 
cannot plan for the future. 
 
 
 
 
b. 
My fear of having my cancer getting worse 
gets in the way of enjoying life. 
 
 
 
 
c. 
I am afraid of my cancer getting worse. 
 
 
 
 
d. 
I am more nervous since I was diagnosed 
with prostate cancer. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
27 
 
45. Outlook: How true is each of the following statements for you? (Choose one response on each line) 
 
 
Not at all 
A little bit 
Somewhat 
Quite a bit 
Very much 
a. 
I feel that my cancer has given me 
a better outlook on life. 
 
 
 
 
 
b. 
I feel that coping with cancer has 
made me a stronger person. 
 
 
 
 
 
 
 
46. Are there any other issues or concerns about your prostate cancer or your treatment that you would like to 
mention? 
 
 
 
 
 
 
 
 
 
 
 
 
 
Thank you very much for completing this survey. Please return in one of the enclosed postage paid 
envelopes or mail to address on front of survey. 
 
Please also review and complete the HIPAA form if you agree to provide authorization for us to review your 
medical records regarding your prostate cancer and treatment.  
 
 
 

 
28 
Second Follow Up Survey 
 
General Questions 
 
1. Today’s date: 
__ __ / __ __ / 2 0 __ __ 
M  M 
  D  D     Y  Y  Y  Y 
 
2. What was your last PSA value? (approximate value): 
  
.   
   ng/ml 
 
 Don’t know 
 
 
3. When was the date of your last PSA? (approximate date):   
/   
 
 
 
Month   Year 
 
 
 
 
 
 
 Don’t know 
 
4. PSA: How true has each of the following statements been for you during the past 4 weeks? 
Choose one response on each line. 
Not 
at all 
A little 
bit 
Somewhat 
Quite 
a bit 
Very 
much 
a. I keep close track of my PSA 
 
 
 
 
 
b. Knowing my PSA level is comforting to me 
 
 
 
 
 
c. I live in fear that my PSA will rise 
 
 
 
 
 
 
5. Since your initial treatment for prostate cancer, did your doctor ever tell you that your prostate cancer came back 
(recurred) or progressed (got worse)? 
 
 
 Yes 
 
 
 No 
 
 
6. Since you were diagnosed with prostate cancer, has a doctor ever told you that your prostate cancer had spread 
to other areas of your body? 
 
 
 Yes 
 
 
 No 
 
 
7. These next questions are about the treatments for prostate cancer that you have received up to the present 
time (even if you have told us about them before).  
For each of the following types of treatment, please check the one(s) you have received and indicate the date you 
received it (or started it): 
 
Type of Treatment 
I have received this 
treatment 
Date received or 
started 
Active Surveillance (My doctor will monitor 
how I am doing without directly treating the 
cancer) 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
Prostate surgery (radical prostatectomy), 
which would remove the whole prostate.  
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 

 
29 
HIFU / High Intensity Focused Ultrasound 
(ultrasound waves cross tissue to destroy the 
part of the prostate that had cancer) 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
Cryotherapy (freezing the part of the prostate 
that had cancer) 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
Laser therapy 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
Radio Frequency Ablation 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
Photodynamic therapy 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
External Beam Radiation Therapy or IMRT 
(radiation treatment requiring more than 2 
weeks of treatment) 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
Stereotactic Body Radiation Therapy 
(SBRT) (radiation treatment requiring less 
than 2 weeks of treatment) 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
Brachytherapy (radioactive seeds) This 
involves having radioactive seeds placed 
within the prostate 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
Proton Beam Therapy 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
Any other type of radiation therapy? 
Describe:___________________________ 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
Hormonal treatments to lower 
testosterone (e.g. Lupron, Zoladex, 
Firmagon, Eligard, Vantas, etc) 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
Surgical removal of testicles 
(Orchiectomy) 
 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
Chemotherapy (docetaxel, cabazitaxel, 
other) 
 
__ __ / __ __ / __ ___ 
  M M     D   D      Y  Y 
 
8. How did you make your treatment decision? 
 I made the decision alone 
 I made the decision together with a family member or friend 
 I made the decision together with my doctor, nurse, or health practitioner 
 I made the decision together with a family member or friend and my doctor, nurse, or health practitioner 
 My doctor, nurse, or health practitioner made the decision 
 I don’t know or remember how the decision was made 

 
30 
 
9. What were the most important factors you considered in making your treatment decision? (Check all that apply) 
 Best chance for cure of my cancer 
 Minimize side effects related to sexual function 
 Minimize side effects related to urinary function 
 Minimize side effects related to bowel function 
 Minimize financial cost 
 Amount of time and travel required to receive treatments 
 Length of recovery time 
 Amount of time away from work 
 Burden on family members 
 Reduction of worry and concern about cancer 
 
10. Have you been hospitalized for complications from your prostate cancer treatment or for any other problems after 
receiving prostate cancer treatment? 
 Yes 
a. What was the reason for the hospitalization? 
 
___________________________________________ 
b. How many days did you spend in the hospital? ___ ___ 
 
 No 
 
11. Did you experience any (other) complication or unexpected outcome within 3 months after your prostate cancer 
treatment? 
 Yes: If yes, please describe: _______________________________________ 
 No 
 
Current Health 
12. In general, would you say your health is: 
 Excellent 
 Very good 
 Good 
 Fair 
 Poor 
 Very poor 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
31 
For the next set of questions, indicate which best describes your health TODAY. 
 
13. Mobility: 
 I have no problems walking 
 I have slight problems walking 
 I have moderate problems walking 
 I have severe problems walking 
 I am unable to walk 
 
14. Self-care: 
 I have no problems washing or dressing myself 
 I have slight problems washing or dressing myself 
 I have moderate problems washing or dressing myself 
 I have severe problems washing or dressing myself 
 I am unable to wash or dress myself 
 
15. Usual activities  
(e.g. work, study, housework, family or leisure activities): 
 I have no problems doing my usual activities 
 I have slight problems doing my usual activities 
 I have moderate problems doing my usual activities 
 I have severe problems doing my usual activities 
 I am unable to do my usual activities 
 
16. Pain / Discomfort: 
 I have no pain or discomfort 
 I have slight pain or discomfort 
 I have moderate pain or discomfort 
 I have severe pain or discomfort 
 I have extreme pain or discomfort 
 
17. Anxiety / Depression 
 I am not anxious or depressed 
 I am slightly anxious or depressed 
 I am moderately anxious or depressed 
 I am severely anxious or depressed 
 I am extremely anxious or depressed 
 
 
18. Mark an X on the scale to indicate how your health is today. 
This scale is numbered from 0 to 100. 
100 means the best health you can imagine. 
0 means the worst health you can imagine. 
 
Please write the number you marked on the scale in the box. 
 
 
 
 
 
 
 
 

 
32 
For the next set of questions, please think about your experience during the past 4 weeks. 
Urinary Issues 
19. In the past 4 weeks how often did you leak urine (pee)? (Choose one) 
 More than once a day 
 About once a day 
 More than once a week 
 About once a week 
 Rarely or never 
 
20. Which of the following best describes your urinary control (ability to hold pee) during the past 4 weeks? 
(Choose one) 
 No urinary control whatsoever 
 Frequent dribbling 
 Occasional dribbling 
 Total control 
 
21. How many pads or adult diapers did you usually use per day to control urine (pee) leakage during the past 4 
weeks? (Choose one) 
 None 
 1 pad per day 
 2 pads per day 
 3 or more pads per day 
 
22. How big a problem, if any, was each of the following during the past 4 weeks? (Choose one for each item) 
 
 
No problem 
Very small 
problem 
Small 
problem 
Moderate 
problem 
Big 
problem 
a. 
Dripping or leaking urine (pee) 
 
 
 
 
 
b. 
Pain or burning on urination (when 
peeing) 
 
 
 
 
 
c. 
Bleeding with urination (when 
peeing) 
 
 
 
 
 
d. 
Weak urine stream (pee) or 
incomplete emptying 
 
 
 
 
 
e. 
Need to urinate (pee) frequently 
during the day 
 
 
 
 
 
 
23. Overall, how big a problem was your urinary function (ability to pee) for you during the past 4 weeks? (Choose 
one) 
 No problem 
 Very small problem 
 Small problem 
 Moderate problem 
 Big problem 
 
Bowel Issues 
24. How big a problem, if any, was each of the following during the past 4 weeks? (Choose one response on each 
line) 
 
 
No problem 
Very small 
problem 
Small 
problem 
Moderate 
problem 
Big 
problem 
a. 
Urgency to have a bowel 
movement (poop) 
 
 
 
 
 
b. 
Increased frequency of bowel 
movements (poop) 
 
 
 
 
 

 
33 
c. 
Losing control of your stools (poop) 
 
 
 
 
 
d. 
Bloody stools (blood with poop) 
 
 
 
 
 
e. 
Abdominal/pelvic/rectal pain 
 
 
 
 
 
 
25. Overall, how big a problem were your bowel habits (ability to poop) during the past 4 weeks? (Choose one) 
 No problem 
 Very small problem 
 Small problem 
 Moderate problem 
 Big problem 
 
Sexual Issues 
 
26. Do you currently use any of the following to help with problems with sexual function? (Choose one response on 
each line) 
 
 
 
 
 
Yes 
No 
a. 
Vacuum suction device 
 
 
b. 
Penile injections (shots) 
 
 
c. 
Urethral pellets or suppositories (Muse) 
 
 
d. 
Penile prosthesis (surgical implant) 
 
 
e. 
Other (please specify): _____________________________ 
 
 
 
 
27. How would you rate each of the following during the past 4 weeks?  
(Choose one response on each line) 
 
 
Very poor 
to none 
Poor 
Fair 
Good 
Very good 
a. 
Your ability to have an erection 
(getting hard for sex)? 
 
 
 
 
 
b. 
Your ability to reach orgasm 
(climax)? 
 
 
 
 
 
 
28. How would you describe the usual QUALITY of your erections (getting hard for sex) during the past 4 weeks? 
(Choose one) 
 None at all 
 Not firm enough for any sexual activity 
 Firm enough for masturbation and foreplay only 
 Firm enough for intercourse 
 
29. How would you describe the FREQUENCY of your erections (getting hard for sex) during the past 4 weeks? 
(Choose one) 
 I NEVER had an erection when I wanted one 
 I had an erection LESS THAN HALF the time I wanted one 
 I had an erection ABOUT HALF the time I wanted one 
 I had an erection MORE THAN HALF the time I wanted one 
 I had an erection WHENEVER I wanted one 
 
 
 

 
34 
30. Overall, how would you rate your ability to function sexually during the past 4 weeks? (Choose one) 
 Very poor 
 Poor 
 Fair 
 Good 
 Very good 
 
31. Overall, how big a problem was your sexual function, or lack of sexual function, for you during the past 4 
weeks? (Choose one) 
 No problem 
 Very small problem 
 Small problem 
 Moderate problem 
 Big problem 
 
32. How often have you been able to ejaculate or “cum” when having sexual activity? 
 All the time 
 Most of the time 
 About half the time 
 Less than half the time 
 None of the time / could not ejaculate 
 
 
33. How would you rate the strength or force of your ejaculation? 
 As strong as it always was 
 A little less strong than it used to be 
 Somewhat less strong than it used to be 
 Much less strong than it used to be 
 Very much less strong than it used to be 
 Could not ejaculate 
 
34. How would you rate the amount or volume of semen or fluid when you ejaculate? 
 As much as it always was 
 A little less than it used to be 
 Somewhat less than it used to be 
 Much less than it used to be 
 Very much less than it used to be 
 Could not ejaculate 
 
35. If you have had any ejaculation difficulties or have been unable to ejaculate, have you been bothered by this? 
 No problem with ejaculation 
 Not at all bothered 
 A little bothered 
 Moderately bothered 
 Very bothered 
 Extremely bothered 
 
 
 
 
36. How big a problem during the past 4 weeks was each of the following for you? (Choose one response on each 
line) 
 
 
No problem 
Very small 
problem 
Small 
problem 
Moderate 
problem 
Big 
problem 
a. 
Feeling depressed 
 
 
 
 
 
b. 
Lack of energy 
 
 
 
 
 
c. 
Change in body weight 
 
 
 
 
 
 
 

 
35 
 
Views Surrounding Impact of Prostate Cancer and Treatment Decision 
 
37. During the past four weeks, how much of the time have you wished that you could change your mind about the 
kind of treatment you chose for your prostate cancer? 
 All of the time 
 Most of the time 
 A good bit of the time 
 Some of the time 
 A little bit of the time 
 None of the time 
 
38. How true or false has the following statement been for you during the past four weeks: 
I feel that I would be better off if I had chosen the other treatment for prostate cancer. 
 Definitely true 
 Mostly true 
 Neither true nor false 
 Mostly false 
 Definitely false 
 
39. How true or false has the following statement been for you during the past four weeks: 
It bothers me that other men with prostate cancer get treatment that is very different from what I have received. 
 Definitely true 
 Mostly true 
 Neither true nor false 
 Mostly false 
 Definitely false 
 
Concerns Surrounding Impact of Prostate Cancer 
Below is a list of comments made by men about prostate cancer and prostate specific antigen (PSA) tests. 
 
40. Please indicate how frequently these comments were true for you during the past week. (Choose one for each 
item) 
 
 
Not at all 
Rarely 
Sometimes 
Often 
a. 
Any reference to prostate cancer brought up strong 
feelings in me. 
 
 
 
 
b. 
Even though it’s a good idea, I found that getting a 
PSA test scared me. 
 
 
 
 
c. 
Whenever I heard about a friend or public figure with 
prostate cancer, I got more anxious about my having 
prostate cancer 
 
 
 
 
d. 
When I thought about having a PSA test, I got more 
anxious about my having prostate cancer. 
 
 
 
 
e. 
Other things kept making me think about prostate 
cancer. 
 
 
 
 
f. 
I felt kind of numb when I thought about prostate 
cancer. 
 
 
 
 
g. 
I thought about prostate cancer even though I didn’t 
mean to. 
 
 
 
 

 
36 
h. 
I had a lot of feelings about prostate cancer, but I 
didn’t want to deal with them. 
 
 
 
 
i. 
I had more trouble falling asleep because I couldn’t 
get thoughts of prostate cancer out of my mind. 
 
 
 
 
j. 
I was afraid that the results from my PSA test would 
show that my disease was getting worse. 
 
 
 
 
k. 
Just hearing the words “prostate cancer” scared me. 
 
 
 
 
 
 
41. Please indicate how frequently these situations have EVER been true for you. 
 
 
Not at all 
Rarely 
Sometimes 
Often 
a. 
I have been so anxious about my PSA test that I 
have thought about delaying it. 
 
 
 
 
b. 
I have been so worried about my PSA test result that 
I have thought about asking my doctor to repeat it. 
 
 
 
 
c. 
I have been so concerned about my PSA test result 
that I have thought about having the test repeated at 
another lab to make sure they were accurate. 
 
 
 
 
 
 
 
 
42. Listed below are a number of statements concerning a person’s beliefs about their own health. During the past 
week, please indicate how much you agree or disagree with each statement. 
 
 
Strongly 
agree 
Agree 
Disagree 
Strongly 
Disagree 
a. 
Because cancer is unpredictable, I feel I 
cannot plan for the future. 
 
 
 
 
b. 
My fear of having my cancer getting worse 
gets in the way of enjoying life. 
 
 
 
 
c. 
I am afraid of my cancer getting worse. 
 
 
 
 
d. 
I am more nervous since I was diagnosed 
with prostate cancer. 
 
 
 
