NCT02706561 · Memorial Sloan Kettering Cancer Center
Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
What this study is about
The purpose of this study is to test two different ways to help men with sexual rehabilitation.
View original scientific description
The purpose of this study is to test two different ways to help men with sexual rehabilitation.
Interventions
BEHAVIORAL
questionnaires
BEHAVIORAL
three in-person sessions
BEHAVIORAL
monthly phone calls
BEHAVIORAL
Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)
BEHAVIORAL
Enhanced Monitoring and Education (EME)
Primary outcome measures
percentages of patients having an Erectile Function Domain (EFD) total score >= 24
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New York, New York
Collaborators
Center for Marital and Sexual Health of South Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 8, 2026 · Source of record for eligibility and locations