A Phase 1 Study to Establish the Feasibility of Enolen (tm) for the Local Delivery of Enzalutamide in Patients With Prostate Cancer
Alessa Therapeutics Inc.
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.
Description
This study is a multi-center, open-label feasibility study. Up to 56 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…
Eligibility
- Age range
- 21+ years
- Sex
- Male
- Healthy volunteers
- No