Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery

Not Applicable

Recruiting

• Conditions: Prostate Cancer; Erectile Dysfunction

• Registration Number: NCT02706561
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to test two different ways to help men with sexual rehabilitation.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-08
• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 224

Inclusion Criteria

• As per medical record, early stage prostate cancer (Pathologic Stage 1/2 with Gleason score </=8; or Pathologic Stage 3 with Gleason score =/< 7)
• As per medical record, radical prostatectomy (RP) conducted either at MSKCC or at another institution
• As per medical record, ≤ 9 months post-RP
• As per medical record, moderate erectile functioning pre-surgery (i.e., 15 or greater on the IIEF Erectile Function Domain (EFD) score, or graded their erections as a 1 or 2 on the standard 5 point Urology Erectile Function scale, or have a score of 6 or greater on the 1-10 pre-surgery erectile function scale on the SMRP assessment or have a total score of 15 or greater on items 2-7 on the Prostrate Quality of Life Survey: Sexual Domain)
• As per self report or as per medical record starting penile injections as part of the erectile rehabilitation program at MSKCC
• In the judgment of the consenting professional able to communicate, comprehend, and complete questionnaires in English

Exclusion Criteria

• Both cavernous nerves fully resected as per surgery report (nerve sparing score of 8 in MSKCC surgeon note), or documented in the progress note that the nerves were fully resected.
• Currently on or has a history of being an Androgen Deprivation Therapy (ADT)
• Has any indication of Prostate-Specific Antigen (PSA)
• As per self report, specific injection phobia
• In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment.
• As per self report or as documented in the medical record, current untreated (e.g. no medication no therapy) major psychiatric disorder (schizophrenia, major depression). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility prior to consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
percentages of patients having an Erectile Function Domain (EFD) total score >= 24	1 year	The EFD score of \>= 24 will be used to indicate "good" erectile function. This is both a face valid cut-off, and a cut off that is commonly used in the literature as "good" erectile function following radical prostatectomy.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States