NRG-GU 010 Phase III Trial: Tailored Prostate Cancer Treatment Based on Decipher Risk Score (GUIDANCE) PART 1

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 will introduce you to a new clinical trial for men with unfavorable intermediate risk prostate cancer. Risk of prostate cancer spread is estimated by factors like the amount and aggressiveness of tumor in the prostate and certain blood test results. Patients are assigned to a risk group based on these factors. This trial applies to men with unfavorable intermediate risk. A key question for these men is how aggressive treatment needs to be, which is not clear from individual to individual. This means many men are either over or undertreated with the current standard of care.

A new gene test appears to improve prediction for disease spread by about 25%. This trial is checking whether doctors can safely customize treatment based on low or high gene scores. This would potentially reduce unnecessary toxicity from overtreatment and improve outcomes in those with higher need.

This trial is funded by the government and conducted by NRG, a nonprofit research cooperative of academic and private cancer clinics. NRG's mission is to improve the lives of cancer patients by conducting multi-institution clinical trials that improve medical standards of care. For more information, click the link to the next video.