Actively Recruiting
Enzalutamide Implants (Enolen) in Patients With Prostate Cancer
Led by Alessa Therapeutics Inc. · Updated on 2026-02-27
56
Participants Needed
7
Research Sites
218 weeks
Total Duration
On this page
Sponsors
A
Alessa Therapeutics Inc.
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study is to assess whether the Enolen is safe and delivers anti-androgen medication locally in patients that are planning for radical prostatectomy.
CONDITIONS
Official Title
Enzalutamide Implants (Enolen) in Patients With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age at least 21 years old
- Histologically confirmed adenocarcinoma of the prostate
- Planning for radical prostatectomy
- At least 1 prostate lesion measurable by MRI of 0.5 cm or larger
- Gleason score 3+4 or higher for Cohorts A and B; Gleason score 3+3 with high risk features or 3+4 for Cohort C
- Willingness to undergo post-treatment MRI imaging
- Ability to understand and sign informed consent
- ECOG performance status of 0 or 1
- Adequate organ function including neutrophil count ≥ 1000 cells/μL, hemoglobin ≥ 9 g/dL, platelets ≥ 100,000 cells/μL, creatinine clearance ≥ 50 mL/min, bilirubin <1.5x upper limit normal (ULN) or <3x ULN if Gilbert's syndrome
- Liver enzymes (AST, ALT, alkaline phosphatase) less than 2.5x ULN
- Agreement to use highly effective contraception or abstinence during the study and for three months after prostatectomy
You will not qualify if you...
- Prior radiotherapy or surgery for prostate cancer
- Ongoing hormonal therapy for prostate cancer or hormone therapy within 3 months before treatment start
- Prior prostate procedures such as transurethral resection, microwave thermotherapy, high-intensity focused ultrasound, or minimally invasive BPH procedures
- Inability or unwillingness to undergo MRI, including contraindications such as pacemakers or incompatible implants
- Presence of metallic hip or other implants that affect prostate MRI quality
- Inability to provide valid informed consent due to medical or psychiatric conditions
- Presence of metastatic disease
- No evidence of extracapsular extension of disease
- Increased risk of refractory urinary retention from transperineal procedure
- Prostate infection history within 2 years
- Medical conditions or circumstances preventing prostatectomy
- History of bleeding disorders or anticoagulation therapy that cannot be stopped safely
- Any condition impairing ability to comply with study procedures or undergo prostatectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Mary Bird Cancer Center
Metairie, Louisiana, United States, 70002
Actively Recruiting
3
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
4
VA Portland Health Care System
Portland, Oregon, United States, 97239
Not Yet Recruiting
5
Atlantic Urology Specialists
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
6
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
7
Aurora Urology
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
Research Team
B
Bonnie Wettersten, MS
CONTACT
P
Pamela Munster, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here