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

Completed · Phase 1

Conditions studied: Prostate Adenocarcinoma, Lower Urinary Tract Symptoms

In brief

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.

Key facts

Study ID

NCT04284761

Run by

Alessa Therapeutics Inc.

People needed

17

Starts

2020-10-11

Expected to finish

2023-05-03

Last updated by the study team

2024-06-24

Who can join

Age: 35 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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