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

NCT ID: NCT04284761

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-11
• Study Completion Date: 2023-05-03

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.

Conditions

Prostate Adenocarcinoma; Lower Urinary Tract Symptoms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biolen

Biolen bicalutamide implant. Single implantation. In situ until prostatectomy

Group Type: EXPERIMENTAL

Bicalutamide implant

Intervention Type: COMBINATION_PRODUCT

Biolen bicalutamide implant

Interventions

Bicalutamide implant

Biolen bicalutamide implant

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Alessa Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamela Munster, MD

Role: STUDY_DIRECTOR

Alessa Therapeutics Inc.

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

Countries

United States; Australia; New Zealand

Other Identifiers

CP-001

Identifier Type: -

Identifier Source: org_study_id