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A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer

NCT04284761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-06-24

No results posted yet for this study

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.

Conditions

  • Prostate Adenocarcinoma
  • Lower Urinary Tract Symptoms

Interventions

COMBINATION_PRODUCT

Bicalutamide implant

Biolen bicalutamide implant

Sponsors & Collaborators

  • Alessa Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Pamela Munster, MD · Alessa Therapeutics Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-11
Primary Completion
2023-05-03
Completion
2023-05-03
FDA Drug
Yes

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04284761 on ClinicalTrials.gov