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

Phase 1

Completed

• Conditions: Prostate Adenocarcinoma; Lower Urinary Tract Symptoms
• Interventions: Combination Product: Bicalutamide implant

• Registration Number: NCT04284761
• Lead Sponsor: Alessa Therapeutics Inc.

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.

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-26
• Study Start: 2020-10-11
• Primary Completion: 2023-05-03
• Study Completion: 2023-05-03
• Status Verified: 2023-08
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biolen	Bicalutamide implant	Biolen bicalutamide implant. Single implantation. In situ until prostatectomy

Primary Outcome Measures

Name	Time	Method
Safety as measured by number and incidence of adverse events	change from baseline to radical prostatectomy up to 12 weeks after implantation	Adverse Events

Secondary Outcome Measures

Name	Time	Method
change in prostate size	change from baseline to radical prostatectomy up to 12 weeks after implantation	prostate measurement by MRI
change in Prostate Specific Antigen (PSA)	change from baseline to radical prostatectomy up to 12 weeks after implantation	PSA level
change in tumor size	change from baseline to radical prostatectomy up to 12 weeks after implantation	tumor measurement by MRI

Trial Locations

Locations (4)

Australian Clinical Trials; 🇦🇺 Wahroonga, New South Wales, Australia

Tauranga Urology Research; 🇳🇿 Tauranga, North Island, New Zealand

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States

University of Wollongong; 🇦🇺 Wollongong, New South Wales, Australia