This phase II trial studies how well flutamide works in treating patients with prostate cancer on androgen suppression undergoing brachytherapy. Flutamide blocks the effects of testosterone and slows the growth and spread of tumor cells. Giving flutamide before brachytherapy may work better in patients with prostate cancer on androgen suppression.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03507608.
PRIMARY OBJECTIVE:
I. To confirm deoxyribonucleic acid (DNA) double strand breaks occur in prostate cancer tissue following pulse‐dose flutamide administration in patients who are androgen suppressed, as compared to control patients receiving placebo.
EXPLORATORY OBJECTIVE:
I. To explore the feasibility of detecting cancer‐specific alterations in DNA methylation and structure within urine and plasma, and the kinetics for these measures when compared with prostate-specific antigen (PSA) values and clinical response.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive flutamide orally (PO) 6‐12 hours prior to undergoing brachytherapy. Patients then undergo brachytherapy and transperineal biopsy on day 0.
ARM II: Patients receive placebo PO 6‐12 hours prior to undergoing brachytherapy. Patients then undergo brachytherapy and transperineal biopsy on day 0.
After completion of study treatment, patients are followed up at 1 and 6 months.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorDaniel Yeong-Jin Song