Prostate Cancer Clinical Trial
Official title:
Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
NCT number | NCT02706561 |
Other study ID # | 15-317 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 8, 2015 |
Est. completion date | December 2025 |
The purpose of this study is to test two different ways to help men with sexual rehabilitation.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | Center for Marital and Sexual Health of South Florida |
United States,
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 |
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