NCT04284761

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2020

Typical duration for phase_1

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

October 11, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2023

Completed
Last Updated

June 24, 2024

Status Verified

August 1, 2023

Enrollment Period

2.6 years

First QC Date

February 12, 2020

Last Update Submit

June 21, 2024

Conditions

Prostate AdenocarcinomaLower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

  • Safety as measured by number and incidence of adverse events

    Adverse Events

    change from baseline to radical prostatectomy up to 12 weeks after implantation

Secondary Outcomes (3)

  • change in prostate size

    change from baseline to radical prostatectomy up to 12 weeks after implantation

  • change in tumor size

    change from baseline to radical prostatectomy up to 12 weeks after implantation

  • change in Prostate Specific Antigen (PSA)

    change from baseline to radical prostatectomy up to 12 weeks after implantation

Study Arms (1)

Biolen

EXPERIMENTAL

Biolen bicalutamide implant. Single implantation. In situ until prostatectomy

Combination Product: Bicalutamide implant

Interventions

Bicalutamide implantCOMBINATION_PRODUCT

Biolen bicalutamide implant

Biolen

Eligibility Criteria

Age35 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Australian Clinical Trials

Wahroonga, New South Wales, 2076, Australia

Location

University of Wollongong

Wollongong, New South Wales, 2500, Australia

Location

Tauranga Urology Research

Tauranga, North Island, 3112, New Zealand

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

bicalutamide

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pamela Munster, MD

    Alessa Therapeutics Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Biolen bicalutamide implant
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 26, 2020

Study Start

October 11, 2020

Primary Completion

May 3, 2023

Study Completion

May 3, 2023

Last Updated

June 24, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(2)NZ(1)US(1)