NCT07685249Not yet recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
RESTORE-PC: Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment: A Randomized Feasibility Trial
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 12 Jun 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- Duke University
- Diseases
- Prostate cancer
- NCT number
- NCT07685249
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Sept 2026 to the primary completion date, 30 Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Unable to engage in pelvic floor physical therapy or penile rehabilitation protocol.
- History of prior local or systemic treatment for prostate cancer
Other illness
- 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.
Other
- Recieved non-nerve-sparing treatment (when applicable).
- Inability to complete study video visits or questionnaires.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.