Spots Global Cancer Trial Database for A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
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Trial Identification
Brief Title: A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
Official Title: A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
Study ID: NCT04284761
Interventions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 35 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Australian Clinical Trials, Wahroonga, New South Wales, Australia
University of Wollongong, Wollongong, New South Wales, Australia
Tauranga Urology Research, Tauranga, North Island, New Zealand
Contact Details
Name: Pamela Munster, MD
Affiliation: Alessa Therapeutics Inc.
Role: STUDY_DIRECTOR
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