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Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment

Study acronym: RESTORE-PC
StatusNot Yet Recruiting
PhaseNot applicable
Started2026-09
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 13 months later across 2 updates Jul 2028 → Sep 2029
See other at-risk trials from Duke University

Amendment history

2026-09-02
critical
Study Status v2
Primary completion pushed: 2028-08 → 2029-09
Completion pushed: 2028-08 → 2029-09
Start date2026-08→2026-09
2026-08-05
minor
Study Status v1
Primary completion pushed: 2028-07 → 2028-08
Completion pushed: 2028-07 → 2028-08
Start date2026-07→2026-08
2026-06-30
minor
Original filing
455 trials monitored
See 53 trials at risk
2,471 trials monitored
See 156 trials at risk
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.
Trial Details
NCT Number NCT07685249
Lead Sponsor Duke University
Conditions Prostate Cancer, Urinary Incontinence, Erectile Dysfunction
Enrollment 30 participants
Start Date 2026-09
Primary Completion 2029-09 (estimated)
Study Completion 2029-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-03