Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland

Major Program
Cancer Prevention Clinical Trials Network
Research Group
Prostate and Urologic Cancer
National Cancer Institute (NCI)
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT04530552
Apalutamide is an anti-androgen that blocks the effect of testosterone on prostate cancer growth. This phase IIa trial is designed to determine whether very low doses of apalutamide, given for 3 to 4 weeks before prostate surgery to men with prostate cancer confined to the prostate gland, reduces plasma levels of PSA (a biomarker of apalutamide's ability to block testosterone). If low dose apalutamide lowers PSA levels in this setting, further study of this agent in men with localized prostate cancer who wish to delay definitive therapy with surgery or radiation may be warranted.
Apalutamide, Quality-of-Life Assessment, Biospecimen Collection
Localized Prostate Carcinoma, Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8
Juan Chipollini, Hsiao-Hui (Sherry) Chow, Mike M. Nguyen, John K. Parsons, Christian P. Pavlovich, Peter A. Pinto, Michael J. Whalen

See list of participating sites