Summary

This study is being done to see if adding chemotherapy to the usual treatment for advanced prostate cancer helps patients live longer. The drug is already approved by the FDA for treating prostate cancer. However, it is usually used only after hormonal therapy and apalutamide are no longer working. The study will also look at a test to see if it can help doctors decide which patients might benefit the most from adding the drug. Doctors do not know yet if this test will be useful in making treatment choices. If it is helpful, it could become a regular part of care for men with advanced prostate cancer.

Description

This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.

Principal Investigator

Kok Hoe Chan

Study Coordinator

Jongie Shelton

Faculty Contact

Lisa Luikart - lisa.luikart@vandaliahealth.org

Research Contact

Lisa Luikart 

CAMC Cancer Research - 304-388-9944

Sex

Male

Age

18+

NCT Number

NCT06931340

IRB Number

25-1304

Phase(s)

3