A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Lower Urinary Tract Symptoms
- Prostate Adenocarcinoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Biolen bicalutamide implantMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 35 years and 125 years
- Gender
- Only males
Description
This prospective, multi-center, single-arm feasibility study is planned to assess the safety and patient tolerance of Biolen for the localized delivery of bicalutamide into the prostate in patients presenting for treatment of prostate cancer. Study participants will have placement of the drug elutin...
This prospective, multi-center, single-arm feasibility study is planned to assess the safety and patient tolerance of Biolen for the localized delivery of bicalutamide into the prostate in patients presenting for treatment of prostate cancer. Study participants will have placement of the drug eluting Biolen and be followed through scheduled radical prostatectomy.
Tracking Information
- NCT #
- NCT04284761
- Collaborators
- Not Provided
- Investigators
- Study Director: Pamela Munster, MD Alessa Therapeutics Inc.
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