Investigating the Benefits of Combining Chemotherapy with Hormonal Therapy for Prostate Cancer

Recruiting · Phase 3 · Castration-Sensitive Prostate Carcinoma and related conditions · 30 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This trial studies whether adding docetaxel to hormonal therapy and apalutamide can improve treatment for men with prostate cancer that has spread to other parts of the body. Docetaxel is a type of chemotherapy that helps stop cancer cells from growing. Hormonal therapy reduces male hormones to slow prostate cancer growth. The goal is to see if this combination works better than hormonal therapy and apalutamide alone.

The trial ID is NCT06931340. This is a Phase 3 trial, meaning it is looking at how well the treatment works and its safety. It is not regulated by the FDA for drugs or devices. The study aims to include about 1,260 participants.

Who can join

Men aged 18 years or older with confirmed prostate cancer that has spread. They must not have had prior chemotherapy for prostate cancer and need to meet other health criteria. The trial team will confirm who is eligible to participate.

Conditions

Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8

Age group

Adult, Older adult

Sex

Male

The study team makes the final call on eligibility.

What happens in the study

Participants will be placed into two groups by chance. One group will receive hormonal therapy and apalutamide, while the other group will receive the same treatment plus docetaxel. Everyone will have regular scans and may provide blood samples during the study.