NCT04284761

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Alessa Therapeutics Inc. · Industry
• Sex: Male
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prostate Adenocarcinoma
• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Bicalutamide implant	Biolen bicalutamide implant

Timeline

• Start date: 2020-10-11
• Primary completion: 2023-05-03
• Completion: 2023-05-03
• First posted: 2020-02-26
• Last updated: 2024-06-24

Locations

4 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated drug study