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Recruiting

NCT Number: NCT02706561

Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery

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

Recruiting

Interested in participating?

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Key information

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Location status: Recruiting

Location contact

Rebecca Saracino, PhD

CONTACT

646-888-0263

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Behavioral

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kelly McConnell, PhD

CONTACT

[email protected]

646-888-0026

Rebecca Saracino, PhD

CONTACT

[email protected]

646-888-0263

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Center for Marital and Sexual Health of South Florida

Registry information

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2016
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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