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

Mass General Brigham

Status: Enrolling

Conditions: Erectile Dysfunction Following Radical Prostatectomy

Treatments: Device: MED3000 topical gel

Study type: Interventional

Funder types: Other

Identifiers

NCT05673005

2021P002976

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

MED3000 topical gel treatment

Experimental group

Description:

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

Treatment:

Device: MED3000 topical gel