Rehabilitation and Sex Therapy to Improve Recovery After Prostate Cancer Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-arm, randomized feasibility trial at Duke Health enrolling adult men treated for localized prostate cancer who are starting pelvic floor physical therapy. All participants receive penile rehabilitation education and a vacuum erection device, with PDE5 inhibitors allowed as part of usual care. One group also receives ten telehealth sex-therapy sessions over six months; the other group does not. Outcomes include patient-reported urinary and sexual health measures over 24 months and qualitative interviews at 6 and 12 months to gauge feasibility and acceptability.

Why it matters

Who can join: the full rules

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 treating clinician assessment.
* Inability to complete study video visits or questionnaires.
* History of prior local or systemic treatment for prostate cancer

Where it's running

• Duke University Medical Center
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Rebecca A Shelby, PhD — Duke University
• Study coordinator: Michael W Willis, BA
• Email: michael.w.willis@duke.edu
• Phone: 919-681-8437

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.