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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04284761




Registration number
NCT04284761
Ethics application status
Date submitted
12/02/2020
Date registered
26/02/2020
Date last updated
24/08/2023

Titles & IDs
Public title
A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
Scientific title
A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
Secondary ID [1] 0 0
CP-001
Universal Trial Number (UTN)
Trial acronym
Biolen-PC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Adenocarcinoma 0 0
Lower Urinary Tract Symptoms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combination Product - Bicalutamide implant

Experimental: Biolen - Biolen bicalutamide implant. Single implantation. In situ until prostatectomy


Combination Product: Bicalutamide implant
Biolen bicalutamide implant
Intervention code [1] 0 0
Combination Product
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety as measured by number and incidence of adverse events
Timepoint [1] 0 0
change from baseline to radical prostatectomy up to 12 weeks after implantation
Secondary outcome [1] 0 0
change in prostate size
Timepoint [1] 0 0
change from baseline to radical prostatectomy up to 12 weeks after implantation
Secondary outcome [2] 0 0
change in tumor size
Timepoint [2] 0 0
change from baseline to radical prostatectomy up to 12 weeks after implantation
Secondary outcome [3] 0 0
change in Prostate Specific Antigen (PSA)
Timepoint [3] 0 0
change from baseline to radical prostatectomy up to 12 weeks after implantation

Eligibility
Key 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.
Minimum age
35 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/05/2023
Sample size
Target
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Australian Clinical Trials - Wahroonga
Recruitment hospital [2] 0 0
University of Wollongong - Wollongong
Recruitment postcode(s) [1] 0 0
2076 - Wahroonga
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
New Zealand
State/province [2] 0 0
North Island

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alessa Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04284761
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pamela Munster, MD
Address 0 0
Alessa Therapeutics Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04284761