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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Biolen bicalutamide implant
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
Safety as measured by number and incidence of adverse events
Adverse Events
Time frame: change from baseline to radical prostatectomy up to 12 weeks after implantation
change in prostate size
prostate measurement by MRI
Time frame: change from baseline to radical prostatectomy up to 12 weeks after implantation
change in tumor size
tumor measurement by MRI
Time frame: change from baseline to radical prostatectomy up to 12 weeks after implantation
change in Prostate Specific Antigen (PSA)
PSA level
Time frame: change from baseline to radical prostatectomy up to 12 weeks after implantation
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