COMPLETED

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

Conditions

Erectile Dysfunction Following Radical Prostatectomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-01

Study Completion:2024-08-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05673005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Martin Kathrins, MD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Martin Kathrins, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-01

Study Completion Date2024-08-09

Study Record Updates

Study Start Date2023-04-01

Study Completion Date2024-08-09

Terms related to this study

Additional Relevant MeSH Terms

Erectile Dysfunction Following Radical Prostatectomy