NCT04530552

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the effects of low dose apalutamide on circulating levels of prostate specific antigen (PSA). SECONDARY OBJECTIVES: I. To determine the effect of low dose apalutamide on: Ia. Reversibility of testosterone levels 7-14 days post intervention; Ib. Post-intervention plasma trough apalutamide concentration; Ic. Health-related quality of life. EXPLORATORY OBJECTIVE: I. To determine the effects of apalutamide on intra-prostatic immune cell infiltration and Gleason score and the effects of tobacco/alcohol use on the study endpoints. OUTLINE: Patients receive apalutamide orally (PO) on study. Patients also undergo collection of blood samples throughout the study. After completion of the trial intervention, patients are followed up at 7-10 days and at 60 days.

Conditions

• Localized Prostate Carcinoma
• Prostate Adenocarcinoma
• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Apalutamide	Given PO
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2021-07-23
• Primary completion: 2024-11-06
• Completion: 2027-01-31
• First posted: 2020-08-28
• Last updated: 2026-04-01
• Results posted: 2025-08-29

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study