A Study of Docetaxel + ARN-509 in Castration-Resistant Prostate Cancer

Prostate Cancer Clinical Trial

Official title: A Phase 2 Study of Docetaxel Plus Apalutamide in Castration-Resistant Prostate Cancer Patients Post Abiraterone Acetate

Status Terminated

Clinical Trial Summary

This research study is studying a combination of drugs as a possible treatment for castration-resistant prostate cancer.

The interventions involved in this study are:

• Docetaxel (a type of chemotherapy)

• Apalutamide (the study medication, also known as ARN-509)

• Prednisone (a corticosteroid given to prevent reactions to docetaxel).

• Leuprolide acetate (also known as Lupron, a GnRH agonist or similar drug which is standard of care, causes chemical castration which greatly lowers the level of testosterone in the body)

Clinical Trial Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

Apalutamide is considered an investigational product, which is believed to reduce the growth of prostate cancer cells. The FDA (the U.S. Food and Drug Administration) has not approved apalutamide as a treatment for any disease, but it is being studied in prostate cancer. Docetaxel is an approved therapy for this type of cancer. The FDA has not approved the combination of the two drugs in any use.

In this research study, the investigators are evaluating the combination of two drugs, docetaxel with apalutamide. The investigators will keep track of participants' prostate-specific antigen (PSA), scans, and overall health to determine how well this drug combination works at treating this type of cancer. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT03093272
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Terminated
• Phase: Phase 2
• Start date: June 23, 2017
• Completion date: December 31, 2019