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

NCT03507608 | Completed Early Phase 1 Results DMC FDA Drug

• 2 other identifiers: J1851IRB00167697
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Fold-change Post Flutamide Exposure

  To confirm DNA double-strand breaks occur in prostate cancer tissue following pulse-dose flutamide administration in patients who are androgen suppressed. A value less than 1 indicates a decrease and a value greater than 1 indicates an increase.

  Post Flutamide exposure up to 12 hours

Study Arms (2)

flutamide

EXPERIMENTAL

50mg flutamide prior to brachytherapy and prostatic biopsy

Drug: Flutamide

placebo

PLACEBO COMPARATOR

placebo prior to brachytherapy and prostatic biopsy

Other: Placebo

Interventions

Flutamide DRUG

50mg flutamide prior to brachytherapy and prostatic biopsy

flutamide

Placebo OTHER

placebo prior to brachytherapy and prostatic biopsy

placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: males with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed prostate cancer
• At least one biopsy core with Gleason 7 or higher disease
• The patient has decided to undergo brachytherapy plus androgen suppression as treatment modality for his prostate cancer (with or without supplemental external beam radiation)
• Suitable volume of disease for biopsy:
• clinically palpable disease corresponding to (ipsilateral to) any involved core on biopsy
• Signed study-specific consent form prior to registration

You may not qualify if:

• Known hypersensitivity or allergic response to flutamide
• Severe hepatic impairment
• Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Patrick C. Walsh Fund: collaborator

Study Sites (1)

SKCCC at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Lee E, Coulter J, Mishra A, Caramella-Pereira F, Demarzo A, Rudek M, Hu C, Han M, DeWeese TL, Yegnasubramanian S, Song DY. Induction of double-strand breaks with the non-steroidal androgen receptor ligand flutamide in patients on androgen suppression: a study protocol for a randomized, double-blind prospective trial. Trials. 2023 Dec 16;24(1):809. doi: 10.1186/s13063-023-07838-4.

  PMID: 38104131 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Flutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dana Kaplin
• Organization: Johns Hopkins SOM, Dept of Radiation Oncology

dkaplin1@jh.edu

443-690-7007

Study Officials

• Daniel Song, M.D.

  SKCCC at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The initial phase is a 6-patient single-arm run-in phase to test feasibility and rule out futility of the intervention. All patients within the run-in phase will receive 50mg flutamide prior to brachytherapy and prostatic biopsy. If futility is ruled out (\>1 patients with DSBs on biopsy), then accrual will continue in the randomized in a 2:1 ratio (12:6 patients), for an all-trial total of 18 patients receiving flutamide vs 6 patients receiving placebo.

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 25, 2018
• Study Start: May 10, 2019
• Primary Completion: September 30, 2024
• Study Completion: July 3, 2025
• Last Updated: October 16, 2025
• Results First Posted: October 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)