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Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression

NCT03507608 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-10-16

Study results available
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Summary

This is a prospective, single-center, two-phase study to assess the efficacy of single pulsed-dose flutamide in creating double strand breaks (DSBs) in prostate cancer within patients receiving central androgen suppression and brachytherapy.

Conditions

Interventions

DRUG

Flutamide

50mg flutamide prior to brachytherapy and prostatic biopsy

OTHER

Placebo

placebo prior to brachytherapy and prostatic biopsy

Sponsors & Collaborators

  • Patrick C. Walsh Fund

    collaborator UNKNOWN

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Daniel Song, M.D. · SKCCC at Johns Hopkins

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-10
Primary Completion
2024-09-30
Completion
2025-07-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03507608 on ClinicalTrials.gov