Two Studies for Prostate Cancer Patients: Testing Less Intense Treatment for Low Gene Risk and More Intense Treatment for High Gene Risk

Program Overview

This study uses the Decipher risk score to guide treatment for prostate cancer patients. The Decipher score helps determine how likely the cancer is to spread. For patients with a low risk score, the study compares radiation therapy alone to the usual combination of radiation and hormone therapy. The aim is to see if radiation alone can control the cancer as effectively while reducing side effects. For patients with a high risk score, the study adds a drug called darolutamide to the usual treatment to see if it better controls the cancer and prevents it from spreading.

Description

The study has two main parts: one for patients with a low Decipher score and one for those with a high score.

For patients with a low score, the study compares two treatments:

• Radiation therapy alone.
• Radiation therapy combined with hormone therapy (androgen deprivation therapy or ADT).

For patients with a high score, the study compares:

• Radiation therapy and hormone therapy (ADT).
• Radiation therapy, hormone therapy, and an additional drug called darolutamide.

The study aims to find out if these different approaches can effectively control prostate cancer and prevent it from spreading. It also looks at overall survival, time to cancer returning, and quality of life related to sexual and hormonal health, fatigue, and cognitive function.

Participants will be followed up at regular intervals after treatment to monitor their health and the effectiveness of the treatment.

Eligibility Criteria