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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

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

Conditions
-----------------
Erectile Dysfunction Following Radical Prostatectomy

Intervention / Treatment
-----------------
* Device: MED3000 topical gel


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Medical device (MED3000)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MED3000 topical gel treatment<br>All qualified enrolled patients will receive treatment with MED3000 topical gel on demand through the 12-week follow-up visits. | Device: MED3000 topical gel<br>* Topical gel that has been shown to improve erectile dysfunction when used as needed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of MED3000 topical gel on erectile function | To investigate the effect of MED3000 topical gel for treatment of erectile dysfunction after nerve sparing prostatectomy (based on Erectile Function domain of the International Index of Erectile Function) | 12 weeks | 
| Effect of MED3000 topical gel on erectile function after 12 weeks based on minimally clinically important difference | To observe a mean change from baseline of the IIEF-EF domain in patients after nerve sparing prostatectomy treated with MED3000, assessed at treatment completion after 12 weeks, greater than or equal to the minimally clinically important difference (MCID) of 4. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of MED3000 topical gel (SEAR questionnaire) | The efficacy of MED3000 in patients at weeks 4, 8 and 12 using: The change from baseline in Self-Esteem and Relationship (SEAR) questionnaire for men | 12 weeks | 
| The change from baseline in Urinary incontinence using the Expanded Prostate Cancer Index Composite (EPIC) (Efficacy) | The efficacy of MED3000 in patients at weeks 4, 8 and 12 | 12 weeks | 
| Change from baseline in all domains of the IIEF. | The efficacy of MED3000 in patients at weeks 4, 8 and 12 | 12 weeks | 
| Efficacy of MED3000 topical gel on post-prostatectomy incontinence | The change from baseline in 24 hour pad weight and usage number per day at 12 weeks. | 12 weeks | 
| Efficacy of MED3000 topical gel on stretched flaccid penile length | The change from baseline of the stretched flaccid penile length following 12-weeks of treatment | 12 weeks | 
| Adverse events of MED3000 topical gel | Treatment-related adverse events in male patients and female partners occurring during treatment with MED3000. | 12 weeks |