NRG-GU 010 Phase III Trial: Tailored Prostate Cancer Treatment Based on Decipher Risk Score (GUIDANCE) PART 3

March 9, 2023

The NRG-GU 010 phase III trial, known as Guidance, aims to optimize treatment strategies for prostate cancer based on the Decipher risk score. This score evaluates the tumor's potential for spreading, enabling personalized therapy selection.

For patients with low risk scores, the trial compares radiation therapy alone to the standard approach of radiation therapy combined with hormone therapy (androgen deprivation therapy). Radiation therapy employs high-energy x-rays or particles to eliminate tumor cells and shrink tumors. Androgen deprivation therapy impedes the production or action of male sex hormones like testosterone, which contribute to prostate cancer development. Administering radiation therapy alone may yield similar cancer control and prevent spread while minimizing side effects associated with hormonal therapy.

In patients with higher Decipher gene risk, the trial assesses the addition of darolutamide to the standard treatment of radiation therapy and hormone therapy. Darolutamide inhibits androgen actions within tumor cells and the body. The inclusion of darolutamide in the usual treatment regimen may enhance cancer control and prevent its spread.

The Guidance trial emphasizes personalized care by matching treatment intensity to the individual's cancer aggressiveness, leading to more targeted and effective therapies for prostate cancer patients.

Read the Full Video Transcript

Speaker 1: This video is an overview of a new study for men with unfavorable intermediate risk prostate cancer, and high gene scores. A standard therapy for men with unfavorable intermediate risk prostate cancer is radiation therapy with hormone therapy for six months. Radiation therapy is high energy X-rays targeted at the prostate, which is located deep in the pelvis. Radiation shrinks or kills cancer cells to prevent metastasis, which is spread to the rest of the body. Testosterone is a chemical that can fuel the growth of prostate cancer. Hormone therapy, also known as androgen deprivation therapy blocks the body's production of testosterone and can slow prostate cancer growth. A key question for men with high gene scores is whether we can decrease the chance of cancer spread by intensifying hormone treatment without extending its duration. On this study, men with high gene scores get randomly assigned to receive either the standard treatment of radiation therapy with hormone therapy or standard treatment with additional anti testosterone medication.

Neither doctors nor patients on the study get to decide which treatment they receive. Men and their doctors can decide on what radiation they receive as usual. There is no placebo, meaning men will know which treatment they are receiving. Doctors will continue to follow all study participants over time to check for side effects and perform routine tests to see if the cancer is growing back. The primary benefit of enrolling on this trial is helping men diagnosed with prostate cancer in the future receive treatment customized to their risk, potentially reducing the chance of cancer spread. For more information, scan the QR code shown here.