MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction

Eligibility Criteria

• * Men who underwent robotic bilateral nerve-sparing radical prostatectomy between 18 and 36 months prior to study commencement
• * Subjects are 18-48 months status-post radical prostatectomy
• * Subjects have any degree of erectile dysfunction based on IIEF questionnaire
• * Age 40 - 70 at study commencement
• * Diagnosed with low/intermediate-risk prostate cancer:
• * PSA \< 20 ng/ml
• * Gleason score =\< 8
• * Prostate Cancer stage =\< T3a
• * Normal pre-radical prostatectomy erectile function (IIEF \>=26) or equivalent response on EPIC
• * Baseline erectile dysfunction at time of screening (despite use of erectogenic aids of any kind) and enrolment following washout (IIEF-ED domain \<=25)
• * Sexually active, in a stable heterosexual relationship for at least 6 months prior to screening
• * Able to understand and complete patient questionnaires
• * Serum prostate specific antigen (PSA) undetectable (no evidence of disease recurrence)
• * Able to consent to participate
• * Documented written informed consent from both patient and his female partner
• * Anatomical abnormalities in the genitalia or pelvic region such as severe phimosis
• * Post-Radical Prostatectomy complications that could impact safety or effectiveness of medical therapy for erectile function (treatment for pelvic hematoma, urinary or intestinal fistula, unresolved anastomotic leak)
• * Tumor upstaging beyond T3a
• * Incomplete / sub-total nerve sparing on either side
• * Previous or scheduled treatment with pelvic salvage radiotherapy and/or androgen deprivation therapy
• * Prior receipt of androgen deprivation therapy
• * Any other condition that would prevent the patient from completing the study, as judged by the Principal Investigator