Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-24 @ 3:24 PM
NCT ID:
NCT03821792
Brief Summary:
This phase II trial studies how well abiraterone acetate, prednisone, and apalutamide work in treating patients with hormone-naive prostate cancer that has spread to other places in the body. Androgen can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate and apalutamide may lessen the amount of androgen made by the body.
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine if a baseline molecular-pathologic androgen receptor response (AR-response) signature predicts efficacy to abiraterone plus apalutamide in patients with hormone-naive metastatic prostate cancer (HNMPCa).
SECONDARY OBJECTIVES:
I. Evaluate the efficacy of abiraterone acetate plus apalutamide in patients with HNMPCa.
II. Evaluate the safety of abiraterone acetate plus apalutamide in patients with HNMPCa.
III. Explore the relationship between molecular markers and clinical efficacy outcomes.
OUTLINE:
Patient receive abiraterone acetate orally (PO) daily, prednisone PO twice daily (BID), and apalutamide PO daily. Cycles repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then for up to 6 months.
Study:
NCT03821792
Study Brief:
Protocol Section:
NCT03821792