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

Phase 0 Completed 25 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Patrick C. Walsh Fund · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2019-05-10
Primary completion: 2024-09-30
Completion: 2025-07-03

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper analysis has yet to be performed. PMID 38104131 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Flutamide	Small molecule	50 mg	Oral