Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery

Prostate Cancer Clinical Trial

Official title:

Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02706561
• Other study ID #: 15-317
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2015
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Christian Nelson, PhD
• Phone: 646-888-0030
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• questionnaires

• three in-person sessions

• monthly phone calls

• Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)

• Enhanced Monitoring and Education (EME)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Center for Marital and Sexual Health of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentages of patients having an Erectile Function Domain (EFD) total score >= 24	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.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center