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

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.

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms; Prostate Adenocarcinoma
• Intervention / Treatment: Combination product: Bicalutamide implant

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Peggy McLaughlin; Phone Number: 6505048501; Email: pmclaughlin@alessatherapeutics.com
• Study Contact Backup: Name: Pamela Munster, MD; Email: pamela.munster@alessatherapeutics.com

Study Locations

• Australia
  • New South Wales
    • Wahroonga, New South Wales, Australia, 2076
      • Australian Clinical Trials
    • Wollongong, New South Wales, Australia, 2500
      • University of Wollongong
• New Zealand
  • North Island
    • Tauranga, North Island, New Zealand, 3112
      • Tauranga Urology Research
• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biolen; Biolen bicalutamide implant. Single implantation. In situ until prostatectomy	Combination product: Bicalutamide implant; Biolen bicalutamide implant

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alessa Therapeutics Inc.
• Investigators: Study Director: Pamela Munster, MD, Alessa Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2020
• Primary Completion (Actual): May 3, 2023
• Study Completion (Actual): May 3, 2023

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Androgen Antagonists; Bicalutamide
• Other Study ID Numbers: CP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes