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

Not Applicable

Recruiting

• Conditions: Erectile Dysfunction Following Radical Prostatectomy
• Interventions: Device: MED3000 topical gel

• Registration Number: NCT05673005
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-05
• Study Start: 2023-04-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-27
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MED3000 topical gel treatment	MED3000 topical gel	All qualified enrolled patients will receive treatment with MED3000 topical gel on demand through the 12-week follow-up visits.

Primary Outcome Measures

Name	Time	Method
Effect of MED3000 topical gel on erectile function	12 weeks	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)
Effect of MED3000 topical gel on erectile function after 12 weeks based on minimally clinically important difference	12 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States