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

Alessa Therapeutics

Status and phase

Completed

Phase 1

Conditions

Lower Urinary Tract Symptoms

Prostate Adenocarcinoma

Treatments

Combination Product: Bicalutamide implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT04284761

CP-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

Male

Ages

35+ years old

Volunteers

No Healthy Volunteers

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.