Clinical trial NCT04284761: A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
Official title: A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Adenocarcinoma
Lower Urinary Tract Symptoms
Lead sponsor: Alessa Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-26
Enrollment: 17
Sex: MALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Biolen bicalutamide implant
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Safety as measured by number and incidence of adverse events
timeFrame: change from baseline to radical prostatectomy up to 12 weeks after implantation
Secondary outcomes:
measure: change in prostate size
timeFrame: change from baseline to radical prostatectomy up to 12 weeks after implantation
measure: change in tumor size
timeFrame: change from baseline to radical prostatectomy up to 12 weeks after implantation
measure: change in Prostate Specific Antigen (PSA)
timeFrame: change from baseline to radical prostatectomy up to 12 weeks after implantation
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
city: Wahroonga
country: Australia
facility: Australian Clinical Trials
state: New South Wales
city: Wollongong
country: Australia
facility: University of Wollongong
state: New South Wales
city: Tauranga
country: New Zealand
facility: Tauranga Urology Research
state: North Island
Study officials:
affiliation: Alessa Therapeutics Inc.
name: Pamela Munster, MD
role: STUDY_DIRECTOR
References: