Clinical trial NCT05673005: MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction
Official title: MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erectile Dysfunction Following Radical Prostatectomy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Medical device (MED3000)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Effect of MED3000 topical gel on erectile function
timeFrame: 12 weeks
measure: Effect of MED3000 topical gel on erectile function after 12 weeks based on minimally clinically important difference
timeFrame: 12 weeks
Secondary outcomes:
measure: Efficacy of MED3000 topical gel (SEAR questionnaire)
timeFrame: 12 weeks
measure: The change from baseline in Urinary incontinence using the Expanded Prostate Cancer Index Composite (EPIC) (Efficacy)
timeFrame: 12 weeks
measure: Change from baseline in all domains of the IIEF.
timeFrame: 12 weeks
measure: Efficacy of MED3000 topical gel on post-prostatectomy incontinence
timeFrame: 12 weeks
measure: Efficacy of MED3000 topical gel on stretched flaccid penile length
timeFrame: 12 weeks
measure: Adverse events of MED3000 topical gel
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Martin Kathrins, MD
role: PRINCIPAL_INVESTIGATOR
References: