NCT02721979

Apalutamide in Treating Patients With Prostate Cancer Who Are in Active Surveillance

A Phase 2 Study of Apalutamide in Active Surveillance Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well apalutamide works in treating patients with prostate cancer who are in active surveillance. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using androgen receptor antagonist apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells.

Detailed description

OUTLINE: Patients receive apalutamide orally (PO) once daily (QD) for 90 days in the absence of disease progression or unacceptable toxicity. After completion of the study treatment, patients are followed up at 180, 365, 545, and 730 days; and at years 3, 4 and 5 by medical record review.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Apalutamide	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-11-02
• Primary completion: 2020-02-12
• Completion: 2021-11-30
• First posted: 2016-03-29
• Last updated: 2023-02-09
• Results posted: 2021-03-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study