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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04284761
Ethics application status
Date submitted
12/02/2020
Date registered
26/02/2020
Date last updated
6/08/2020

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 - 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 - prostate measurement by MRI
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 - tumor measurement by MRI
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) - PSA level
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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Australian Clinical Trials - Wahroonga
Recruitment hospital [2] 0 0
University of Wollongong - Wollongong
Recruitment hospital [3] 0 0
Australian Urology Associates - Melbourne
Recruitment postcode(s) [1] 0 0
2076 - Wahroonga
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
3144 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 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/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
Peggy McLaughlin
Address 0 0
Country 0 0
Phone 0 0
6505048501
Fax 0 0
Email 0 0
pmclaughlin@alessatherapeutics.com
Contact person for scientific queries

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