CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled / 34 target
Drug / intervention
Apalutamide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04530552
NCT04530552Phase 2CompletedMonitor (0.6/mo)Completion was 19mo ago
CompareCT.gov

Clinical Study of Bioactivity of Low Dose Apalutamide in Prostate Cancer Patients Scheduled for Prostatectomy

National Cancer Institute (NCI)·interventional·Posted Aug 28, 2020·Updated Jun 25, 2026

In Brief

A Phase 2 clinical trial evaluating Apalutamide, Biospecimen Collection, and 1 other intervention for Localized Prostate Carcinoma and 3 related conditions. Completed, enrolled 34 participants across 5 sites.

Signals

Enrolling slower than its timeline implies

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocalized Prostate Carcinoma, Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedAug 28, 2020
Enrollment StartJul 23, 2021
Primary CompletionNov 6, 2024
Study CompletionMay 28, 2026
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.8 years ago

Arms & Interventions

Treatment (apalutamide)experimental

Patients receive apalutamide PO on study. Patients also undergo collection of blood samples throughout the study.

Drug: ApalutamideProcedure: Biospecimen CollectionOther: Quality-of-Life Assessment

Interventions

Apalutamidedrug

Given PO

Biospecimen Collectionprocedure

Undergo collection of blood samples

Quality-of-Life Assessmentother

Ancillary studies