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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Adenocarcinoma, Lower Urinary Tract Symptoms

Intervention / Treatment
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* Combination Product: Bicalutamide implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate. Study participant qualified and planning for radical prostatectomy. At least 1 prostate lesion measurable by MRI > 0.5 cm within one month of screening. PSA > 3 ng/mL within 3 months of screening. Gleason score 3+4 or higher. Study participant must be willing to undergo post-treatment imaging by MRI. ECOG performance status 0 or 1. Exclusion Criteria: Prior radiotherapy or surgery for prostate cancer. Prior or ongoing hormonal therapy for prostate cancer. Prior prostate procedures such as transurethral resection of the prostate, transurethral microwave thermotherapy of the prostate, high-intensity focused ultrasound or minimally invasive BPH procedure. Study participant unwilling or unable to undergo MRI, including patients with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc. Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images. Use of 5 alpha reductase inhibitors (e.g. Finasteride or Dutasteride) within 3 months of screening or total use within the last two years prior to screening of > 3 months. Presence of any metastatic disease. Prostate volume more than 80 cc at prior MRI imaging. I-PSS score >20. History of prostate infection.

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Biolen bicalutamide implant
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biolen<br>Biolen bicalutamide implant. Single implantation. In situ until prostatectomy | Combination Product: Bicalutamide implant<br>* Biolen bicalutamide implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by number and incidence of adverse events | Adverse Events | change from baseline to radical prostatectomy up to 12 weeks after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in prostate size | prostate measurement by MRI | change from baseline to radical prostatectomy up to 12 weeks after implantation | 
| change in tumor size | tumor measurement by MRI | change from baseline to radical prostatectomy up to 12 weeks after implantation | 
| change in Prostate Specific Antigen (PSA) | PSA level | change from baseline to radical prostatectomy up to 12 weeks after implantation |