NCT02706561 Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
| NCT ID | NCT02706561 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 224 participants |
| Start Date | 2015-12-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 224 participants in total. It began in 2015-12-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to test two different ways to help men with sexual rehabilitation.
Eligibility Criteria
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.
Contact & Investigator
Rebecca Saracino, PhD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT02706561 clinical trial?
This trial is open to male participants only, aged 21 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02706561 currently recruiting?
Yes, NCT02706561 is actively recruiting participants. Contact the research team at jamesr@mskcc.org for enrollment information.
Where is the NCT02706561 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT02706561 clinical trial?
NCT02706561 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Rebecca Saracino, PhD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 224 participants.
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