Helping Men with Sexual Rehabilitation After Prostate Cancer Surgery

This study is testing two different approaches to help men with sexual rehabilitation after prostate cancer surgery. It compares "Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)" with "Enhanced Monitoring and Education (EME)." You may be able to join if you are a man aged 21 or older who has undergone radical prostatectomy for early-stage prostate cancer within the last nine months and had moderate erectile function before surgery. The study aims to see what percentage of men achieve an Erectile Function Domain score of 24 or higher one year after starting the program. The current status of this study is unclear.

Study design
This interventional study plans to enroll 224 men. It is designed to compare two behavioral interventions.
What's involved
Participants will complete questionnaires, attend three in-person sessions, and receive monthly phone calls.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 1 year, indicating follow-up for at least that duration.

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NCT02706561

Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery

Recruiting
NAAges 21+InterventionalSupportive care
Memorial Sloan Kettering Cancer Center
~224 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:questionnairesthree in-person sessionsmonthly phone callsAcceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)Enhanced Monitoring and Education (EME)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
percentages of patients having an Erectile Function Domain (EFD) total score >= 24
Measured over 1 year
Prostate Cancer
Erectile Dysfunction
1 sites across 1 states
New York1
  • Rebecca Saracino, PhD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

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Eligibility criteria

Inclusion

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

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.
  • percentages of patients having an Erectile Function Domain (EFD) total score >= 241 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.