Back to resultsA Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer (Biolen-PC)
Primary Purpose
Prostate Adenocarcinoma, Lower Urinary Tract Symptoms
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Bicalutamide implant
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Adenocarcinoma
Eligibility Criteria
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.
Sites / Locations
- National Institutes of Health Clinical Center
- Australian Clinical Trials
- University of Wollongong
- Tauranga Urology Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biolen
Arm Description
Biolen bicalutamide implant. Single implantation. In situ until prostatectomy
Outcomes
Primary Outcome Measures
Safety as measured by number and incidence of adverse events
Adverse Events
Secondary Outcome Measures
change in prostate size
prostate measurement by MRI
change in tumor size
tumor measurement by MRI
change in Prostate Specific Antigen (PSA)
PSA level
Full Information
NCT ID
NCT04284761
First Posted
February 12, 2020
Last Updated
August 23, 2023
Sponsor
Alessa Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04284761
Brief Title
A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
Acronym
Biolen-PC
Official Title
A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 11, 2020 (Actual)
Primary Completion Date
May 3, 2023 (Actual)
Study Completion Date
May 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alessa Therapeutics Inc.
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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-effects. The objectives of the study are to assess whether the Biolen is safe.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma, Lower Urinary Tract Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Biolen bicalutamide implant
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biolen
Arm Type
Experimental
Arm Description
Biolen bicalutamide implant. Single implantation. In situ until prostatectomy
Intervention Type
Combination Product
Intervention Name(s)
Bicalutamide implant
Intervention Description
Biolen bicalutamide implant
Primary Outcome Measure Information:
Title
Safety as measured by number and incidence of adverse events
Description
Adverse Events
Time Frame
change from baseline to radical prostatectomy up to 12 weeks after implantation
Secondary Outcome Measure Information:
Title
change in prostate size
Description
prostate measurement by MRI
Time Frame
change from baseline to radical prostatectomy up to 12 weeks after implantation
Title
change in tumor size
Description
tumor measurement by MRI
Time Frame
change from baseline to radical prostatectomy up to 12 weeks after implantation
Title
change in Prostate Specific Antigen (PSA)
Description
PSA level
Time Frame
change from baseline to radical prostatectomy up to 12 weeks after implantation
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Munster, MD
Organizational Affiliation
Alessa Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
National Institutes of Health Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Australian Clinical Trials
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
University of Wollongong
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Tauranga Urology Research
City
Tauranga
State/Province
North Island
ZIP/Postal Code
3112
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
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