Enzalutamide Implants (Enolen) in Patients With Prostate Cancer
Start Date
6/21/2024
Completion Date
12/30/2028
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.
Detailed Description
This study is a multi-center, open-label feasibility study. Approximately 45 participants planning for radical prostatectomy will be recruited to assess the safety and patient tolerance of Enolen for the localized delivery of enzalutamide into the prostate. At baseline, patients will undergo multiparametric MRI of the prostate. Study participants will have placement of the drug eluting Enolen implants followed by a standard of care prostatectomy 6-12 weeks or 4-12 months post-implant procedure. Twenty participants in Cohort A receive up to 16 implants and have a prostatectomy planned between weeks 6 and 12 post-implant procedure. Twelve participants in Cohort B receive 16 implants and have a prostatectomy planned between weeks 6 and 12 post-implant procedure. Twelve participants in Cohort C receive 16 implants and have a prostatectomy planned between months 4 and 12 post-implant procedure. If the participant is unwilling to undergo the prostatectomy by 12 months, they must agree to close monitoring with imaging by MRI every three months and biopsies, as indicated, for up to 24 months post-implant procedure. Study participants are followed for 2-6 weeks post-prostatectomy. Participants will be followed for an additional 6-12 weeks post surgery. Clinical labs and correlative sample collection and patient quality of life questionnaires will be administered at follow-up visits.
Eligibility Criteria
Age Range: 21 years to No maximum
Interventions
enzalutamide
Conditions
Locations
Urology Associates of Central California
Fresno, California 93720
United States
University of California San Francisco Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94158
United States
Northwestern University
Chicago, Illinois 60611
United States
Mary Bird Cancer Center
Metairie, Louisiana 70002
United States
Johns Hopkins University School of Medicine
Baltimore, Maryland 21287
United States
National Institutes of Health Clinical Center
Bethesda, Maryland 20892
United States
VA Portland Health Care System
Portland, Oregon 97239
United States
Atlantic Urology Specialists
Myrtle Beach, South Carolina 29572
United States
Virginia Commonwealth University
Richmond, Virginia 23298
United States
Aurora Urology
Milwaukee, Wisconsin 53215
United States