Overview
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.
Description
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.
Eligibility
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