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

Lower Urinary Tract Symptoms Clinical Trial

— Biolen-PC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04284761
• Other study ID #: CP-001
• Status: Completed
• Phase: Phase 1
• Start date: October 11, 2020
• Est. completion date: May 3, 2023

Study information

• Verified date: August 2023
• Source: Alessa Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 3, 2023
• Est. primary completion date: May 3, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Prostate Adenocarcinoma

Intervention

Combination Product:
• Bicalutamide implant
Biolen bicalutamide implant

Locations

Country	Name	City	State
Australia	Australian Clinical Trials	Wahroonga	New South Wales
Australia	University of Wollongong	Wollongong	New South Wales
New Zealand	Tauranga Urology Research	Tauranga	North Island
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Alessa Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change in prostate size	prostate measurement by MRI	change from baseline to radical prostatectomy up to 12 weeks after implantation
Secondary	change in tumor size	tumor measurement by MRI	change from baseline to radical prostatectomy up to 12 weeks after implantation
Secondary	change in Prostate Specific Antigen (PSA)	PSA level	change from baseline to radical prostatectomy up to 12 weeks after implantation