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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04284761
Ethics application status
Date submitted
12/02/2020
Date registered
26/02/2020

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
Other interventions - Bicalutamide implant

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


Other interventions: Bicalutamide implant
Biolen bicalutamide implant
Intervention code [1] 0 0
Other interventions
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
NA
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04284761