Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment (NCT07685249) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
United States30 participantsStarted 2026-08
Plain-language summary
This study is being done at Duke Health and includes adult men who have been treated for localized prostate cancer. The goal is to see if it is feasible and acceptable to offer sex therapy by telehealth after prostate cancer treatment.
All participants receive pelvic floor physical therapy and education about penile rehabilitation, including use of a vacuum erection device. Participants are randomly assigned to one of two groups. One group receives pelvic floor physical therapy plus telehealth sex therapy, with about ten sessions over six months. The other group receives pelvic floor physical therapy alone.
Participants complete questionnaires about urinary and sexual health at the start of the study and over the next two years. Short interviews are also done at 6 and 12 months. Medicines for erectile function are prescribed as part of usual clinical care and are not part of the study treatment.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Age 18 years or older.
* Biopsy-confirmed localized prostate adenocarcinoma.
* Treated with nerve-sparing radical prostatectomy, radiotherapy, or cryoablation as primary index therapy for prostate cancer at Duke Health.
* Initiating pelvic floor physical therapy as part of routine clinical care.
* Pre-treatment International Index of Erectile Function-5 (IIEF-5) score meeting the eligibility threshold, with or without aids, determined by medical record chart review (when documented within 4 months prior to index treatment) or collected post-treatment with participant recall anchored to the month prior to treatment. Eligibility threshold for the IIEF-5 is at or above 17.
* Able to read and understand English to complete patient-reported outcome measures.
* Ability to provide informed consent.
Exclusion Criteria
* Any androgen deprivation therapy (ADT) given for prostate cancer treatment or planned during the intervention or follow-up period, including neoadjuvant, concurrent, or adjuvant ADT.
* Recieved non-nerve-sparing treatment (when applicable).
* Unable to engage in pelvic floor physical therapy or penile rehabilitation protocol.
* Need for additional or secondary prostate cancer treatment during the intervention period.
* Documented cognitive impairment or impairment that would interfere with participation.
* Major psychiatric concern that would interfere with ability to consent or participate, such as schizophrenia, based on the medical record or…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment feasibility as measured by number of participants recruited
Timeframe: From initiation of recruitment to completion of accrual, up to 1 year
2
Enrollment feasibility, as measured by consent rate
Timeframe: From initiation of recruitment to completion of accrual, up to 1 year
3
Randomization feasibility
Timeframe: From initiation of recruitment to completion of accrual, up to 1 year
4
Retention feasibility
Timeframe: 12 months
5
Number of participants who complete study assessments