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

NCT04943536 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-27

No results posted yet for this 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.

Conditions

  • Prostate Adenocarcinoma

Interventions

DRUG

bicalutamide

localized anti-androgen therapy

RADIATION

Stereotactic body radiation therapy

localized radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alessa Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Deborah Citrin, MD · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2027-04-24
Completion
2027-08-15
FDA Drug
Yes

Countries

  • United States

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 NCT04943536 on ClinicalTrials.gov