Studying New Treatment for Prostate Cancer That Returns After Surgery

Recruiting · Phase 3 · Biochemically Recurrent Prostate Carcinoma and related conditions · 34 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This clinical trial looks at how well a combination of treatments works for men with prostate cancer that has come back after surgery. It compares standard treatment with a new approach that includes a medicine called apalutamide and radiation therapy. The goal is to see if this enhanced treatment helps control cancer better than standard treatment alone, especially for patients whose cancer has spread outside the pelvis.

This is a Phase 3 trial, which means it is looking at how effective the treatments are and how safe they are. The trial is FDA-regulated and aims to include around 804 participants.

Who can join

Men aged 18 and older can join this trial if they have had surgery for prostate cancer and have a rise in a blood test called PSA. Patients must not have any evidence of cancer spread outside the pelvis based on certain imaging tests. The trial team will confirm each person's eligibility before they can participate.

Conditions

Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, 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 randomly placed into different groups. Some will receive standard treatment, while others will get the enhanced treatment that includes apalutamide and radiation. Everyone will go through imaging tests to help guide their treatment. The treatments are given over a period of time, and participants will be monitored for their response to the therapies.