Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors
Phase: NA
Conditions: Prostatic Neoplasm
Sponsor: University of Minnesota

PROTOCOL TITLE: Restore: Gay Men and Prostate Cancer Aim III 
 
 
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PROTOCOL COVER PAGE 
 
 
Protocol Title 
Restore: Gay Men and Prostate Cancer Aim III 
Principal 
Investigator/Faculty 
Advisor 
Name:  B.R. Simon Rosser 
Department: Epidemiology and Community Health 
Telephone Number: 612-625-8329 
Email Address: aslele@umn.edu 
Student Investigator 
Name: N/A 
Current Academic Status (Student, Fellow, Resident): 
  
Department: 
Telephone Number: 
Institutional Email Address: 
Scientific 
Assessment 
Not required, Minimial Risk Study 
Version 
Number/Date: 
Version 1, 8/29/18 
 

PROTOCOL TITLE: Restore: Gay Men and Prostate Cancer Aim III 
 
 
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Table of Contents 
 
1.0 
Objectives ................................................................................................................ 4 
2.0 
Background .............................................................................................................. 4 
3.0 
Study Endpoints/Events/Outcomes ......................................................................... 6 
4.0 
Study Intervention(s)/Interaction(s) ......................................................................... 7 
5.0 
Procedures Involved ................................................................................................ 8 
6.0 
Data Banking............................................................................................................ 9 
7.0 
Sharing of Results with Participants ........................................................................ 9 
8.0 
Study Duration ......................................................................................................... 9 
9.0 
Study Population ...................................................................................................... 9 
10.0 Vulnerable Populations .......................................................................................... 10 
11.0 Number of Participants .......................................................................................... 10 
12.0 Recruitment Methods ............................................................................................. 11 
13.0 Withdrawal of Participants ..................................................................................... 12 
14.0 Risks to Participants .............................................................................................. 12 
15.0 Incomplete Disclosure or Deception ...................................................................... 13 
16.0 Potential Benefits to Participants ........................................................................... 13 
17.0 Data Management ................................................................................................. 13 
18.0 Confidentiality......................................................................................................... 13 
19.0 Provisions to Monitor the Data to Ensure the Safety of Participants .................... 14 
20.0 Provisions to Protect the Privacy Interests of Participants ................................... 15 
21.0 Compensation for Research-Related Injury .......................................................... 15 
22.0 Consent Process .................................................................................................... 16 
23.0 Setting .................................................................................................................... 16 
24.0 Multi-Site Research................................................................................................ 17 
25.0 Resources Available .............................................................................................. 17 
26.0 References ............................................................................................................. 17 
 

PROTOCOL TITLE: Restore: Gay Men and Prostate Cancer Aim III 
 
 
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ABBREVIATIONS/DEFINITIONS 
Include any abbreviations or definitions for key or technical terms you use in your 
protocol. 
• 
PCa: Prostate Cancer 
• 
GBM: Gay and Bisexual Men 
• 
MSM: Men who have sex with men 
 
 

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1.0 
Objectives 
 
Prostate cancer (PCa) is the most common invasive cancer among gay, bisexual, and 
other men who have sex with men (GBM), with documented disparities, yet it is severely 
under-researched. Because gay sex differs from vaginal sex, physiologically; the results 
from 614 studies focused on heterosexual men likely do not generalize to GBM with 
PCa. This research will advance the field in three ways: First, there have been no 
rehabilitation studies specific to GBM survivors of PCa, so clinicians have no relevant 
studies to inform best practice with their GBM patients. Second, most PCa studies have 
tested only one rehabilitation component. We will conduct the first study of a multi-
component, biobehavioral rehabilitation program on quality of life, including both urinary 
and sexual function. Third, almost all PCa studies have focused on men recently treated 
for PCa. We will study both men recently treated (last 2 years) and men post-treatment 
(2+ years), using a stratified design.  
 
The long-term objective of this research is to improve the health of GBM survivors of 
PCa and to provide an evidence base for rehabilitation. In Aim III, we will evaluate an 
online rehabilitation program tailored for GBM that addresses both the sexual and 
urinary effects of PCa treatment. This protocol addresses Aim III. “To evaluate the 
effects of a structured online rehabilitation program for GBM PCa survivors”. Note: The 
recruitment of participants for this study has already been reviewed and approved (see 
Aim II). 
   
2.0 
Background, Significance of Research Question/Purpose, 
and Existing Literature 
 
PCa is common in GBM, and GBM have poorer outcomes than heterosexual men with 
PCa.  However, there have been no studies to assess the effects of PCa rehabilitation in 
GBM, and none to assess effects of rehabilitation on gay sex. Our study premise is that 
structured rehabilitation, tailored for GBM with PCa, will improve their quality of life by 
reducing the negative sexual and urinary effects of PCa treatment. PCa is the most 
common non-skin cancer among men, with 180,890 new diagnoses in 2016.1 Three 
studies have examined whether sexual orientation and male partners are risk factors for 
PCa, but results conflict.2-4 
 
A recent IOM report concluded “that substantial research is needed” (p.294) to address 
the health disparities of LGBT persons, citing “cancer rates, risk and treatment 
(particularly prostate cancer among older gay and bisexual men)” [IOM’s emphasis] 
(p.284) as a prioritized, under-researched area.5 In our published literature review, we 
could find only 30 publications regarding GBM with PCa published this century in 
English, a rate of 1.9 publications per year.6  
 
There have been only 5 studies of GBM with PCa with n’s>10. The first was a qualitative 
study (N=36) which concluded GBM have little-to-no understanding of the prostate, 
treatment or sexual sequelae.7 The second was a Romanian study where 12 GBM 
reported worse sexual outcomes following PCa treatment than 17 heterosexual men.8 In 
the third, 92 GBM reported significantly worse urinary and bowel outcomes, poorer 
mental health, worse quality-of-life but better sexual outcomes post-treatment than 
published norms.9 The fourth found 96 GBM had lower Gleason scores at diagnosis, and 
more distress at anejaculation, than 460 heterosexual men.10,11 The fifth (N=16) 

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concluded sexual effects of treatment are particularly “severe” for GBM. While the poor 
sexual outcomes demand research, the negative impact on quality-of-life adds 
urgency.12 
 
Sexual function is an important component of health13 and predictor of quality of life,14,15 
including for older men.13,15,16 While DSM-517 defines “sexual dysfunction” as “a clinically 
significant disturbance in a person’s ability to respond sexually”,  erectile functioning in 
PCa treatment is typically operationalized as “sufficient for vaginal penetration.”12,18,19 
This gold standard is “irrelevant for gay sex.” 12 Physiologically, anal penetration requires 
a greater degree of penile rigidity than vaginal penetration20,21 which may explain poorer 
sexual outcomes.   
 
There are three main treatments for PCa. Radical prostatectomy, the gold standard 
treatment recommended by 95% of US urologists,22-24 causes urinary incontinence (UI), 
total semen loss, and potentially persistent erectile dysfunction (ED).22 For younger 
(<60), otherwise-healthy (heterosexual) men with rehabilitation, 76% report erections 
sufficient for vaginal sex within 3 years.22 GBM may be less likely than heterosexual men 
to choose radical prostatectomy possibly because of the sexual effects. 25 Radiation and 
cryotherapy have long-term ED outcomes similar to or worse than radical 
prostatectomy,26 while also causing chronic rectal complications that may preclude anal 
sex.24,27 Systemic treatment involves hormonal treatments, usually in combination with 
surgery and radiation, with worse outcomes. Active surveillance is the alternative to 
treatment, but repeated biopsies can result in ED.28,29     
 
For almost all men, PCa treatment negatively impacts sexual functioning,30-32 sense of 
masculinity,30,33,34 and/or self-esteem.35-38 Erectile dysfunction (ED) and urinary 
incontinence (UI) are the most common sequelae of PCa treatment. Without 
rehabilitation, frequent UI is estimated to be 3.3-21%,39,40 and ED, 40-76% in PCa 
patients at 2 year post-treatment.39-41 GBM with PCa face additional challenges including 
the loss of the prostate as a site for sexual pleasure in receptive anal sex,24,42 persistent 
rectal irritation or pain sufficient to prevent receptive anal sex,12,21 loss of ejaculate 
(which appears more central in gay sex43,44), and climacturia(leaking urine during 
orgasm) impacting oral sex.  Weak erections have been hypothesized to prevent GBM 
with PCa from following CDC safer sex guidelines, increasing risk of HIV transmission.45 
Some GBM adjust their role-in-sex (from insertive to receptive) to accommodate 
dysfunction,10 but this has not been well researched. PCa in GBM intersects with issues 
of minority status,43 discrimination,43 and stigmatization,35,43 including less familial42,46-49 
and social support,42,47-49 and less partner involvement in treatment.42 For HIV+ GBM, 
HIV treatments and immune deficiency may alter the risk of PCa24,50-52 and cancer 
virulence.24 GBM with PCa have described post-operative sex education as 
“disingenuous” and “coy” because it never addresses gay sex.53 Challenges navigating 
(real or perceived) heterosexual bias in the medical setting12,42,43,54,55 support 
groups,44,54,56 and health systems42,43 all worsen treatment outcomes57 and mental 
health.9,57 Patient distrust of the medical community12 and reluctance to disclose 
sexuality42,56 are also barriers, with 21% of 2,560 older (50+) LGBT  reporting they are 
not “out” to health providers and 13% reporting homophobic care.58 In addition, 31% of 
older LGBT report depression and 40% a history of suicidal ideation.58 Since older GBM 
are already at higher risk of depression59-62 and suicide,63-68 the lack of PCa treatment 
studies tailored for GBM is a major concern. 
 

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To ensure our structured rehabilitation program is evidence-based and state-of-the-art 
best practice, we conducted a systematic literature search using “prostate” and 
synonyms by “sexual rehabil*” “urine”, and synonyms, since 1980, in English, French or 
Spanish. This yielded 614 references. We highlight three findings. First, of the 614 
papers, only 127 (20.7%) focused on rehabilitation. Rehabilitation appears an under-
researched area relative to treatment. Second, with few exceptions, research on 
rehabilitation has focused on UI or ED as separate issues and taken a component 
approach to studying treatment. But UI and ED often occur together;69 and are the top 
two challenges patients ask for help with, online.70 Combination treatment permits study 
of both outcomes. We conclude a structured treatment program tailored for GBM is the 
appropriate first (and next) step in advancing treatment for GBM with PCa.  
 
Many PCa rehabilitation studies equate erectile functioning with vaginal sex; few studies 
have examined other sexual problems. For example, only two papers have examined 
climacturia. The first estimated 20% of otherwise continent men experience it after 
radical prostatectomy, and showed it increased survivors’ sexual anxiety, avoidance of 
sex, and low orgasmic satisfaction.71 The second estimated prevalence, 4-years post-
treatment, to be 33.9%.72 No treatment studies have been published or used climacturia 
as a primary end point, a gap this study will address.   
 
Of the 614 articles reviewed, 612 focused on vaginal intercourse or erections. None 
were in GBM. There have been no studies (in heterosexuals or GBM) of rehabilitation for 
insertive anal sex, receptive anal sex, and no studies to treat climacturia. This absence 
makes it literally impossible for clinicians to practice evidence based medicine with GBM 
patients. The IOM concludes this failure of science creates and sustains GBM health 
disparities.73  
 
As reflected in the small size of the few published studies, recruitment has been a major 
barrier impeding GBM with PCa research.53 Given our success in recruiting the largest 
sample to date, we are the right team to test new methods for recruitment.  
 
3.0 
Preliminary Data  
Restore-1, our recently completed R21, is only the second NCI-funded study on GBM 
with PCa, and the first to reach publication.74 This study included two cross-sectional 
components: qualitative telephone interviews (n=30) and an online survey was 
conducted (n=193) to determine the examine the experiences of GBM with PCa and 
conduct a needs assessment to inform our current intervention.  In qualitative interviews, 
men described radical prostatectomy as leaving them “humiliated,” “maimed”, “less than 
other gay men,” and “severely depressed.”75,76 Most (88%) GBM assessed their sexual 
functioning as inadequate, post-treatment77 resulting in poorer mental health,76 and 
decreased quality of life (QoL).77 Clinicians address only 3 of the 8 (38%) treatment 
effects commonly experienced by most GBM with PCa; leaving most GBM to treat 
themselves, informally.78 We found no evidence of any standard of care for 
rehabilitation,78 an outcome potentially explained by the lack of science to inform clinical 
practice. Three (2%) participants became HIV-positive after PCa treatment, raising 
concerns whether lack of rehabilitation led to condom difficulties and, ultimately, HIV 
infection.77 Almost all participants expressed interest in a tailored, online rehabilitation 
program.79 

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4.0 
Study Endpoints/Events/Outcomes 
4.1 
Primary Endpoint/Event/Outcome:  
Health Related Quality of Life; measured as combined scores of the FACT-P and BSI-18 
inventories 
Sexual function and bother in anal and oral sex; measured via the EPIC-26 inventory 
and gay sexual functioning inventory 
Urinary function and bother; measured via the EPIC-26 
 
4.2 
Secondary Endpoint(s)/Event(s)/Outcome(s):  
Self-reported climacturia, measured via the Gay Sexual Functioning Inventory, which we 
are developing for this study. 
5.0 
Study Intervention(s)/Interaction(s) 
5.1 
Description:  
The intervention includes six primary focus areas: 
     (1). PDE5-I drugs: Participants will be offered the option to take 60mg sildenafil orally, 
3x per week for 1 year.  Participants for whom it is contraindicated, who are unwilling or 
unable to get a prescription from their physician, who prefer to use an alternative 
erection enhancer not covered by our study, or do not wish to take sildenafil will still be 
included in the intervention.  
     (2). Pelvic floor exercises (a.k.a. Kegels): To strengthen the levator ani muscle, both 
to treat UI and climacturia, videos and educational materials will demonstrate proper 
technique for pelvic floor exercises. For climacturia, we will emphasize voiding bladder 
prior to sex, shaking of the penis; and clenching pelvic floor muscles during orgasm to 
keep sphincters closed.  
     (3). Vacuum pump and (4) masturbatory exercises: Participants will be given a penile 
vacuum pump and encouraged to use it with masturbation to stimulate blood flow to the 
penis. In addition, they receive three different sized dildoes to help with receptive anal 
sex and two penile constriction rings (aka “cock rings”). 
     (5). A gay man’s/couple’s guide to sex after PCa treatment: Our mobile-enabled 
interactive website will have videos modeling how GBM with PCa deal with sexual 
challenges (e.g., disclosing PCa to a sex partner); and a male couple discussing how 
they have good sex, post-treatment. 
    (6). Social support: We will provide participants with a coach to help them in 
rehabilitation, moderated forums and other opportunities for men to exchange advice 
and support with peers and experts. 
 
Participants in the intervention group will receive the following: 
• 
PDE5-I drugs.  Participants will be given a letter and instructions to obtain a 
prescription from their doctor. They will then obtain their drugs online or over the 
phone via our pharmacy partner, Marley Drug. The study will pay directly for 
sildenafil for all intervention participants. 
• 
A welcome package including a vacuum pump, tension bands and anal dilators 
(which are recommended tools in the content), and written educational materials 
(which are also provided in the online intervention). 

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• 
Access to a comprehensive online intervention, including written and video 
educational materials on each focus area, tracking tools to encourage and 
measure adherence, supplemental educational materials, and moderated 
forums. 
• 
Regular contact with study staff, who will encourage adherence, provide advice, 
and answer questions.  In addition, participants will have access to monthly 
expert webinars, with presentations from specialists in prostate cancer and 
sexual health. 
 
6.0 
Procedures Involved 
6.1 
Study Design:   
We will conduct a randomized controlled trial.  Participants will be randomized 1:1 to 
receive either the online intervention or usual care. Treatment groups will be determined 
via permuted block randomization and will be stratified by relationship status and time 
since treatment (<2 years vs 2+years) with blocks of four. 
6.2 
Study Procedures:  
Following successful screening (see below), participants will review an online consent 
form which overview the study, study tasks, outlines risks and benefits, strategies tor 
educe risks, and risk-benefit analysis. After this, they participate in an initial telephone 
call from the project coordinator where they have the opportunity to ask any questions 
and have them answered, as well as verify information for cross-validation purposes. 
Then, if confirmed eligible and unique, they receive access to the baseline survey.  
Participants who complete the baseline survey will then be randomized, via a computer 
assignment, to a treatment or control group.   
Participants in the control group will be notified by email.  Thereafter, they will be 
contacted occasionally with survey links and reminders.  As needed, additional casual 
communications will be used to increase retention.   
  
Participants in the treatment group will be emailed immediately with a username and 
password to access the intervention.  They will be mailed their welcome packet within 
one week.   
 
Surveys will be conducted at baseline, and at 3, 6, 9, 12, 18, and 24 months follow-up.  
Surveys are attached.  
 
Interaction for all participants in our study will include an online screening survey, a 
vetting phone conversation, an email confirmation, followed by an online baseline survey 
and five follow-up surveys.  In addition, all participants can contact the study at any time 
using a 1-800 and/or our study email. In all email and phone contact, we will maintain 
HIPPA compliant standards to ensure no privacy violations. (e.g., we will not describe 
the nature of the study in phone or email messages). In addition, data will be maintained 
in password protected files on a secure server. 
6.3 
Follow-Up:  
Participants will be followed for twenty four months. Participants randomized to the 
intervention group will have access to the website and forums throughout the two years; 
however, it is anticipated that participants will experience the bulk of the intervention 
experiences during the first year. Sildenafil will only be provided for the first twelve 

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months. All participants will receive follow-up surveys at months 3, 6, 9, 12, 18, and 24 
(attached).  
 
6.4 
Individually Identifiable Health Information:  
 
Attached 
 
7.0 
Data Banking 
N/A 
8.0 
Sharing of Results with Participants 
 
The results of this study will be made available to interested participants through the use 
of lay summaries posted on our website. Our format is to use executive summaries 
which report in lay language the main results of the study. In addition, we will email 
updates, including reports and publications to participants. Participants may choose to 
opt out of email updates. 
 
9.0 
Study Duration 
9.1 Describe: 
The duration anticipated for an individual participant’s participation in the study. 
The total duration of participation is 24 months. Follow-up surveys will occur for both 
treatment and control groups at baseline, 3, 6, 12, 18, and 24 months.  For participants 
in the treatment group, PDE5-I drugs will be provided for 12 months, but the online 
intervention will be continue for 24 months. 
 
The duration anticipated to enroll all study participants. We expect enrollment to last 13 
months from January 2019 through February 2020. The duration anticipated to complete 
all study procedures and data analysis. The study will take five years total, including 15 
months of preparation, 37 months of recruitment and intervention, and eight months for 
analysis.  
 
10.0 Study Population 
10.1 Inclusion Criteria:  
Each participant must be: 
• 
An adult biological male who has had sex with a man or men 
• 
Diagnosed with PCa and treated or pending treatment, including but 
not limited to radical prostatectomy, radiation, and/or hormone 
therapy 
• 
Recent problems with sexual and/or urinary function 
• 
Living in the United States or its territories 
• 
A unique, validated individual 
 

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10.2 Exclusion Criteria:  
• 
Cognitive Impairment 
• 
Non-English speaking/reading 
• 
Patients who underwent a bi-lateral, non nerve-sparing, 
prostatectomy (for which rehabilitation is not recommended as 
efficacious). 
 
10.3 Screening:  
Participants will complete an online screening survey to evaluate inclusion criteria 
(attached). Upon completion of the screener, study staff will call each participant to 
confirm identity, confirm screening survey answers and evaluate English and cognitive 
proficiency. Participants’ IP addresses will be used to ensure US location and 
deduplication. 
 
11.0 Vulnerable Populations 
11.1 Vulnerable Populations:  
☐ Children 
☐ Pregnant women/Fetuses/Neonates 
☐ Prisoners 
☐ Adults lacking capacity to consent and/or adults with diminished capacity 
to consent, including, but not limited to, those with acute medical 
conditions, psychiatric disorders, neurologic disorders, developmental 
disorders, and behavioral disorders 
☐ Approached for participation in research during a stressful situation such 
as emergency room setting, childbirth (labor), etc. 
☐ Disadvantaged in the distribution of social goods and services such as 
income, housing, or healthcare 
☐ Serious health condition for which there are no satisfactory standard 
treatments 
☐ Fear of negative consequences for not participating in the research (e.g. 
institutionalization, deportation, disclosure of stigmatizing behavior) 
☐ Any other circumstance/dynamic that could increase vulnerability to 
coercion or exploitation that might influence consent to research or 
decision to continue in research 
☒ Undervalued or disenfranchised social group 
☐ Members of the military 
☐ Non-English speakers 
☐ Those unable to read (illiterate) 
☐ Employees of the researcher 
☐ Students of the researcher 
☐ None of the above 
11.2 Additional Safeguards:  

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This study is designed to address health disparities affecting sexual minority men, so 
inclusion of GBM is central and essential to the study. Stigmatization is the main 
concern. Multiple stigmas have been identified in this population, however we have 
taken care to minimize risk of stigma. With these protecitons, we believe risks will be 
minimal.  
 
12.0 Number of Participants 
12.1 Number of Participants to be Consented:  
We plan to recruit 450 participants: 150 participants who have undergone treatment in 
the past two years and 300 who have had at least two years since their PCa treatment.   
 
We expect 80% power to detect the statistically significantly differences between the 
intervention group and the control group. The power calculation was based on 
standardized effect size = 0.35, total number of observations per participant during the 
course of the study, M = 9, total number of participants, N = 450, assumed within-subject 
variability, σ2 = 0.50, assumed between-subject variability, 𝜏2 = 0.20 and a linear change 
over time. 
 
13.0 Recruitment Methods 
13.1 Recruitment Process:  
Our recruitment strategies, already approved in a separate protocol, will have three 
arms: 
1. Urology Clinics and other Prostate Cancer Organizations: In the spring and summer of 
2018, we built relationships with prominent urology and oncology clinics, urologists and 
other prostate cancer specialists working in private practice, and federally-qualified gay 
health centers and family practice clinics with large gay patient populations, nationwide. 
These medical sources will provide recruitment materials, such as letters, email 
invitations or fliers, to their gay and bisexual patients. Additional recruitment partners in 
this aim may include prostate cancer support groups or community nonprofit 
organizations aimed at cancer survivors.  
2. Online from Cancer Support Sites:  In our preliminary study, we recruited a sizeable 
portion of our sample through the online community Malecare. We will replicate this 
successful strategy with both Malecare and similar organizations providing online 
support services to prostate cancer survivors. 
3. Directly from the GBM community: We will advertise in gay newspapers (eg 
Washington Blade) and in gay men’s chorus concerts programs. In addition, we will 
recruit through organizations designed to serve LGBT seniors, such as SAGE and 
Prime Timers, and similar organizations which are likely to have large populations of 
older GBM.  
Recruitment procedures are described in detail in approved protocol # STUDY00003361  
13.2 Source of Participants: Describe the source of potential participants, e.g., 
Research Experience Program. 
For most of our recruitment strategies, participants will self-identify in response to flyers 
or advertisements.  In addition, clinicians may contact GBM patients, as identified by 

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clinics via electronic medical records, in order to recruit them into the study. This process 
will be carried out entirely by the partnering clinics who currently have access to these 
records. Partner organizations will be provided with a media packet that includes 
materials for both passive (e.g. flyers and posters) and active (e.g. letters) recruitment. 
Recruitment materials will point participants to an online screening survey. Upon 
completion of the screener, potential participants will be contacted by study staff via 
telephone. These recruitment materials are attached. 
13.3 Recruitment Materials:  
Our media kit includes: 
• 
Flyers and posters 
• 
Online and print advertisements 
• 
Letters to potential recruiting partners  
• 
Letters to potential participants 
• 
Press release 
• 
Infographics 
 
13.4 Payment:  
Participants will be paid $50 after completing the baseline survey, and $25 for each 
subsequent survey (3, 6, 12, 18, and 24 months), for a potential total of $275.   
 
14.0 Withdrawal of Participants 
14.1 
Withdrawal Circumstances:  
Participants found to be fraudulent or ineligible (i.e. participants utilizing false information 
to enter the study multiple times) or those who become ineligible (i.e. those who 
experience cognitive decline during the intervention) may be withdrawn from the study.  
14.2 
Withdrawal Procedures:  
Follow-up surveys will be reviewed for suspicious responses.  Participants identified as 
duplicitous will be removed from the study and further follow-up, and their data will not 
be included in the analysis. 
Participants deemed ineligible due to new health concerns or cognition concerns will be 
removed from the intervention, but will receive follow-up surveys. 
 
Participants identified as ineligible or fraudulent through the course of the intervention 
(i.e. via information that is shared on a forum) will remain in the study to prevent 
selection bias, unless there are concerns for their safety. 
14.3 
Termination Procedures:  
N/A 
 
15.0 Risks to Participants 
 

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Foreseeable Risks: We have identified potential risks related to the Aim II study protocol: 
 
1. Risk of breach of confidentiality. Participants are asked to complete the survey in 
private and to guard their confidentiality, however, the researchers have little control 
over who else can see the participant. We assess this risk as “unknown.” 
 
2. Emotional discomfort with sexual and prostate cancer questions. This survey asks 
about sexual, bowel and urinary functioning challenges and their impact on sex. These 
are sensitive areas to be questioned about. While such questions when asked in in-
person interviews are potentially embarassing, it is not clear whether the same questions 
when asked by computer on a survey are experienced as sensitive. Having had over 
15,000 GBM complete sexually focused surveys of similar sensitivity, we note only one 
man to date reported sensitivity concerns sufficient to contact the study. Our experience 
suggests such concerns may be rare (and possibly overstated for online surveys).  
 
3. Anxiety and risk of being “outed”. Older men, closeted men, and those less 
comfortable with or more private about their sexuality and/or a diagnosis of prostate 
cancer may experience anxiety about being “discovered” or “outed” as being 
gay/bisexual/MSM, living with PCa, or both by some third party, particularly in a 
recruitment study that involves snowball sampling, public outreach, and communication 
on sexual functioning. We assess some risk of anxiety as likely. 
 
4. Concern about security of data. Given the potential of any computer system to be 
hacked, there are concerns in online surveys about security of data. We assess these 
risks to participants as minimal and have taken steps described below to minimize these 
risks. 
15.1 Reproduction Risks: N/A 
15.2 Risks to Others: N/A 
16.0 Incomplete Disclosure or Deception 
16.1 Incomplete Disclosure or Deception:  
N/A. We intend to fully disclose and there is no deception. 
17.0 Potential Benefits to Participants 
17.1 
Potential Benefits:  
 
Participants in the intervention arm of this study may benefit from the provision of 
intervention materials worth several hundred dollars. These include free PDE5-I drugs 
for 12 months, the penile vacuum device, three dildoes (which can double as anal 
dilators), two penile constriction rings, and access to videos, interactive forums by 
experts, and the opportunity to read rehabilitation materials tailored to GBM. Participants 
in the control arm will not receive the direct benefits of the intervention; however, they 
may benefit from increased assessment or attention from study staff.  
 
17.2 
Data Management:   
Data will be collected via a series of Qualtrics surveys and managed by study staff.  
17.3 Data Analysis Plan:  
 

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All analyses will be completed in STATA version 12.0.  Comparisons between the 
intervention and control groups and the outcome measures (EPIC Urinary, Hormone, 
Sexual, and Bowel, as well as FACT-P and BSI-18 scores) will be evaluated using 
random coefficient modeling.  Stratified analyses will be conducted by time since 
treatment (2+ years vs <2 years) and relationship status.  Models may be adjusted for 
treatment time, relationship status, comorbidities and demographic variables.   
 
17.3 
Power Analysis:  
We expect 80% power to detect the statistically significantly differences between the 
intervention group and the control group. The power calculation was based on 
standardized effect size = 0.35, total number of observations per participant during the 
course of the study, M = 9, total number of participants, N = 450, assumed within-subject 
variability, σ2 = 0.50, assumed between-subject variability, 𝜏2 = 0.20 and a linear change 
over time. 
17.4 Statistical Analysis: 
See above 
17.5 Data Integrity:  
In online surveys it is not always possible to restrict the study raising the necessity of 
having strong de-duplication and cross-validation protocols to detect fraud.  Our 
experience suggests that between 5-99% of online survey reponses may be fraudulent 
necessitating strong protocols to exclude fake and duplicative surveys. In order to 
guarantee that each survey respondant is a unique, validated individual meeting our 
eligibility requirements, participants will undergo a two-step screening process, including 
both an online screening survey and a telephone vetting conversation.  Fraud will also 
be assessed by monitoring recruitment into the study, watching in particular for 
suspicious entries (e.g., a sudden large participation may signal a bot attack). During de-
duplication and cross-validation, participants’ entry time on study, duration to complete 
the survey, IP address,  age, and zip codes are monitored, as well as answers to 
information that only health professionals and patients with prostate cancer are likely to 
know (e.g. Gleason score; medications).  Surveys that are suspicious are initially flagged 
for closer manual checking. Where a survey is clearly duplicative, only the first complete 
survey will be deemed unique. Where a survey is clearly invalid, it will be rejected. Only 
after a survey has cleared the de-duplicatoin and cross-validation protocol will a 
participant be paid. Finally, in the event of suspicious responses (between valid and 
clearly invalid), we will email the participant to request clarification of the issue. 
 
18.0 Confidentiality 
18.1 Data Security: 
Well-established, state-of-practice, security protocols will be followed. All data will be 
encrypted, stored on a dedicated server behind a firewall, identifying information will be 
separated from the data, and all information and data will be accessible only by 
password to the investigators and their staff. These procedures have proven effective in 
the prior online studies conducted by this research team. 
 
It will not be appropriate to include a copy of the consent form in participants’ medical, 
employment, or educational records, because we do not have access to those records. 

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19.0 Provisions to Monitor the Data to Ensure the Safety of 
Participants 
19.1 Data Integrity Monitoring.  
Protocols for study procedures, data management, and reporting will be created by the 
primary investigator in conjunction with study staff. Monitoring of such proceedings will 
be conducted by the internal methods committee, comprised of the primary investigator, 
methodologist, and two additional investigators as well as study staff.  Reports on data 
integrity will be presented to this committee quarterly. Reports will include review of data 
entry and management procedures, recruitment, randomization, participant 
communication, and surveys.  Each report will include notation of adherence to protocols 
and accuracy of data.   
 
19.2 Data Safety Monitoring.  
 
Data safety will also be monitored and evaluated quarterly by the internal methods 
committee, as described above. While risks in this study are minimal, adverse events will 
be recorded as reported.   Events related to intervention procedures may include: 
reactions to PDE5-i drugs, injury related to pelvic floor exercises or pump use, and other 
adverse events related to the study. Safety data collection will begin as soon as the 
intervention website is open to participants. Because this study presents minimal risk to 
participants, we do not anticipate any conditions that will trigger immediate suspension 
of research. 
 
20.0 Provisions to Protect the Privacy Interests of Participants 
20.1 Protecting Privacy: 
Interaction for all participants in our study will include an online screening survey, a 
vetting phone conversation, an email confirmation, followed by an online baseline survey 
and five follow-up surveys.  In addition, all participants can contact the study at any time 
using our phone number and/or our study email. In all email and phone contact, we will 
maintain HIPPA compliant standards to ensure no privacy violations. (e.g., we will not 
describe the nature of the study in phone or email messages). In addition, data will be 
maintained in password protected files on a secure server. 
Participants in the intervention group will also interact with study staff and other 
participants (in moderated forums).  In addition to the safeguards listed above, 
participants will not be allowed to share personal information (such as full names) on 
forums, and will be informed of the risks of sharing personal information online. 
 
18.2 Access to Participants:  
 
Our research team will not have access to medical records. However, in order to 
evaluate adherence, safety, and analyze the results of our study, we will collect 
information about PDE5-i use, prostate cancer treatment and side effects, and other 
health conditions. This information will be stored on password-protected, secured 
servers and will only be available to research staff who will use it for these purposes. 

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21.0 Compensation for Research-Related Injury 
21.1 Compensation for Research-Related Injury: N/A 
21.2 Contract Language: N/A 
22.0 Consent Process 
22.1 Consent Process (when consent will be obtained):  
Following successful screening for eligibility, each potential participant will be sent an 
individual link for an online “chunked” consent page. (attached)  Participants will view 
separate screens for each topic, specifically: 1) a description of our funding and 
researchers, 2) duration, compensation, and expected survey participation, 3) inclusion 
and exclusion criteria, 4) description of the intervention, 5) description of PDE5-I 
expectations and procedures 6) confidentiality policies, 7) participant risks, 8) benefits, 
and 9) contact information and next steps. At each page of the consent form, 
participants will click to confirm that they understand that page and wish to continue.  On 
a final page, participants will click to confirm that they are eligible and wish to participate. 
22.2 Waiver or Alteration of Consent Process (when consent will not be 
obtained, required information will not be disclosed, or the research 
involves deception):  
N/A 
22.3 Non-English Speaking Participants: 
Because our study intervention includes English-language written and oral 
communication, non-English-speaking participants will not be eligible for this study. 
22.4 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 
years of age): 
N/A 
22.5 Cognitively Impaired Adults, or adults with fluctuating or diminished 
capacity to consent: 
Cognitively impaired adults will not be eligible for this study. 
22.6 Adults Unable to Consent: 
N/A 
 
23.0 Setting 
23.1 Research Sites:  
 
This study will be conducted entirely online. Participants will reside throughout the 
United States and will receive the intervention via a comprehensive website, mailed 
materials, and telephone conversations.  
All team activities, including participant communication, intervention activities, and 
recruitment, will be based at the office facilities of the University of Minnesota Division of 
Epidemiology and Community Health. 

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Recruitment of participants will occur throughout the United States.  Recruitment 
locations may include urologists, community groups in Minnesota and throughout the 
United States, and print and online advertisements.  Recruiting urologists may provide 
printed materials to their GBM patients, with the approval of their local IRB boards. 
 
23.2 International Research: N/A 
23.3 Community Based Participatory Research: N/A 
24.0 Multi-Site Research 
N/A 
25.0 Resources Available 
25.1 Resources Available:  
Our recruitment objectives are more than double the next largest study of GBM with 
PCa, so it is reasonable to doubt the feasibility of our goals. However, we’re uniquely 
positioned to find participants because we have had the most success to date with 
recruitment. In addition, an NCI SPRINT grant provided us the structure to build 
relationships with referring partners nationwide and build the infrastructure needed to 
meet our ambitions. 
 
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