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

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

The investigators are doing this research to evaluate the efficacy and safety of topical MED3000 therapy in men with persistent erectile dysfunction 1.5 to 4 years following radical prostatectomy surgery.

MED3000 is a topical gel that has been developed to treat patients with erectile dysfunction. The investigators postulate that on demand treatment with MED3000 can improve on-demand erectile function among men status-post radical prostatectomy, allowing for some endogenous cavernosal nerve function recovery for 1.5 to 4 years post-surgery among men with normal baseline pre-surgical erectile function.

Inclusion 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

Exclusion Criteria:

• 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