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A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer — Biolen-PC  

Lower Urinary Tract Symptoms Clinical Trial

Official title:
A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer

Clinical Trial Summary

Biolen, a novel implant, is intended to deliver an anti-androgen locally to the prostate gland for the management of prostate disease, while minimizing systemic exposure and its associated side-effects. The objectives of the study are to assess whether the Biolen is safe.

Clinical Trial 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 eluting Biolen and be followed through scheduled radical prostatectomy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04284761
Study type Interventional
Source Alessa Therapeutics Inc.
Contact
Status Completed
Phase Phase 1
Start date October 11, 2020
Completion date May 3, 2023
View Details
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