Alessa Therapeutics Inc.
The study is to assess whether the Enolen is safe and delivers anti-androgen medication locally in patients that are planning for radical prostatectomy.
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…
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 absol…
Localized single delivery of the Enolen implant (polymer + enzalutamide) with planned radical prostatectomy