Status:
COMPLETED
A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
Lead Sponsor:
Alessa Therapeutics Inc.
Conditions:
Prostate Adenocarcinoma
Lower Urinary Tract Symptoms
Eligibility:
MALE
35+ years
Phase:
PHASE1
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-effect...
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04284761
Start Date
October 11 2020
End Date
May 3 2023
Last Update
June 24 2024
Active Locations (4)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
2
Australian Clinical Trials
Wahroonga, New South Wales, Australia, 2076
3
University of Wollongong
Wollongong, New South Wales, Australia, 2500
4
Tauranga Urology Research
Tauranga, North Island, New Zealand, 3112