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Clinical Trials in the USA / NCT04943536
Active, not recruiting Phase 1

Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer

NCT04943536 · tracked via the Priya Life Science USA tracker
Sponsor
Alessa Therapeutics Inc.
Phase
Phase 1
Started
2021-12-07
Last updated
2026-02-27

Condition(s) studied

Prostate Adenocarcinoma

Investigational drug(s) / intervention(s)

bicalutamideStereotactic body radiation therapy

bicalutamide: localized anti-androgen therapy

Stereotactic body radiation therapy: localized radiation therapy

Study summary

This study will be undertaken to evaluate the feasibility of replacing systemic Androgen Deprivation Therapy (ADT) with targeted local delivery of an anti-androgen agent alone in patients in whom ADT + radiation therapy is indicated for the treatment of localized prostate cancer.

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Patients with biopsy proven localized prostate cancer in whom prostate radiation and ADT is appropriate therapy (such as Intermediate Risk localized prostate cancer) * Patients must have at least 1 MRI detected; biopsy proven prostate cancer. * Patients diagnosed as one of the following: 1. National Comprehensive Cancer Network (NCCN) intermediate risk prostate cancer, OR 2. NCCN high risk prostate cancer due to Gleason Grade 4 or 5 AND refuses to receive systemic ADT, OR 3. NCCN high risk prostate cancer due to Prostate Specific Antigen (PSA) \> 20 AND refuses to receive systemic ADT. * Age \>18 years. Exclusion Criteria: * NCCN high risk patients eligible for treatment with systemic ADT who do not refuse systemic ADT. * Patients receiving prior radiotherapy or surgery for prostate cancer. * Patients receiving prior or ongoing ADT. * 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. * 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. * Prostate volume more than 80 cc at prior MRI imaging. * International Prostate Symptom Score ≥ 20.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
National Cancer Institute Bethesda Maryland

More Alessa Therapeutics Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04943536 on ClinicalTrials.gov ↗ ← All trials in the USA