RecruitingPhase 1NCT06257693

Enzalutamide Implants (Enolen) in Patients With Prostate Cancer

A Phase 1 Study to Establish the Feasibility of Enolen (tm) for the Local Delivery of Enzalutamide in Patients With Prostate Cancer


Sponsor

Alessa Therapeutics Inc.

Enrollment

56 participants

Start Date

Jun 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The study is to assess whether the Enolen is safe and delivers anti-androgen medication locally in patients that are planning for radical prostatectomy.


Eligibility

Sex: MALEMin Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new form of enzalutamide — a drug used to treat prostate cancer — delivered as an implant directly into the prostate rather than as a daily pill. The goal is to see whether this localized approach can shrink the cancer before surgical removal of the prostate. **You may be eligible if...** - You are at least 21 years old - You have been diagnosed with prostate cancer confirmed by biopsy - Your cancer is moderate-to-high risk (Gleason score 3+3 with high-risk features, or 3+4 or higher) - You are already planned to have your prostate surgically removed (radical prostatectomy) - Your prostate has at least one measurable lesion on MRI - Your blood counts, kidney, and liver function meet minimum levels **You may NOT be eligible if...** - You have had prior radiation or surgery for prostate cancer - You are currently on or recently completed hormone therapy for prostate cancer (within 3 months) - You have significant heart, kidney, or liver problems - You are unwilling to use effective contraception during and for 3 months after the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGenzalutamide

Localized single delivery of the Enolen implant (polymer + enzalutamide) with planned radical prostatectomy


Locations(7)

Northwestern University

Chicago, Illinois, United States

Mary Bird Cancer Center

Metairie, Louisiana, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

VA Portland Health Care System

Portland, Oregon, United States

Atlantic Urology Specialists

Myrtle Beach, South Carolina, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Aurora Urology

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06257693


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