Clinical trialNCT04530552CompletedPhase 2Interventional

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

SponsorNational Cancer Institute (NCI)Enrollment34Localized Prostate CarcinomaProstate AdenocarcinomaStage I Prostate Cancer AJCC v8Stage II Prostate Cancer AJCC v8

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Juan Chipollini
University of Arizona Cancer Center - Prevention Research Clinic
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Arizona Cancer Center - Prevention Research Clinic
Tucson, Arizona, United States
Usc / Norris Comprehensive Cancer Center
Los Angeles, California, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
Johns Hopkins University/sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Nci - Center for Cancer Research
Bethesda, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Apalutamide →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 23 Jul 2021
Primary completion: 6 Nov 2024
Completion: 28 May 2026
Last update posted: 25 Jun 2026
Registered enrollment: 34
Registry id: NCT04530552

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.