NCT06173362

Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

A Pragmatic Phase II Study Evaluating Tolerability in Prostate Cancer Patients Treated With Abiraterone + Prednisone or Darolutamide

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial compares the effects, good and/or bad of abiraterone and prednisone or darolutamide alone in treating patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Androgens (male hormones) can cause the growth of prostate tumor cells. Abiraterone acetate lowers the amount of androgens made by the body. This may help stop the growth of prostate tumor cells that need androgen to grow. Darolutamide blocks the use of androgens by the tumor cells. Prednisone is used to lessen inflammation and lower the body's immune response. Researchers want to compare the side effects of standard of care (SOC) abiraterone and prednisone or darolutamide alone in treating patients with advanced prostate cancer.

Detailed description

PRIMARY OBJECTIVE: I. Tolerability. SECONDARY OBJECTIVES: I. Tolerability in prespecified subpopulations. II. Prostate-specific antigen (PSA) response at 7 months. OUTLINE: Patients are assigned to 1 of 2 arms per treating physician preference. ARM I: Patients receive abiraterone and prednisone per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study. ARM II: Patients receive darolutamide per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study. After completion of study intervention, patients are followed up for a total of 3 years.

Conditions

• Advanced Prostate Adenocarcinoma
• Stage III Prostate Cancer AJCC v8
• Stage IV Prostate Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Abiraterone	Given abiraterone
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
DRUG	Darolutamide	Given darolutamide
DRUG	Prednisone	Given prednisone

Timeline

• Start date: 2023-11-09
• Primary completion: 2026-11-01
• Completion: 2027-05-01
• First posted: 2023-12-15
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study