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Recruiting
NCT06257693
Enzalutamide Implants (Enolen) in Patients With Prostate Cancer
Conditions: Prostate Adenocarcinoma
Sex: Male
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 45
Sponsor: Alessa Therapeutics Inc.
Location: Urology Associates of Central California Fresno California
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 Criteria
Inclusion Criteria:
1. Age at least 21 years old
2. Histologically confirmed adenocarcinoma of the prostate
3. Study participant qualified and planning for radical prostatectomy
4. At least 1 prostate lesion measurable by MRI greater or equal to 0.5 cm
5. Cohort A and Cohort B: Gleason score 3+4 or higher Cohort C: Gleason score 3+3 with high risk features or 3+4
6. Study participant must be willing to undergo post-treatment imaging by MRI
7. Participants must be able to understand and sign the informed consent form
8. ECOG performance status 0 or 1
9. Adequate organ function, including absolute neutrophil count (ANC) ≥1000 cells/μL, hemoglobin ≥9 g/dL, platelets ≥100,000 cells/μL, estimated creatinine clearance ≥50 mL/min, bilirubin \
Source: ClinicalTrials.gov (NCT06257693). StuddyBuddy aggregates publicly available trial information.