Two Studies for Patients with Unfavorable Intermediate-Risk Prostate Cancer Assessing Less Intense Treatment for Those With a Low Gene Risk Score and a More Intense Treatment for Those with a Higher Gene Risk Score


Full Title

Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE) (NRG-GU010) (CIRB)


The Decipher gene risk scoring system evaluates a prostate cancer for its potential to spread. This study is assessing the use of the Decipher score to match patients with unfavorable intermediate-risk prostate cancers with therapies based on the aggressiveness of their cancers.

In patients with low gene risk scores, this study is comparing radiation therapy alone to the usual treatment of radiation therapy and hormone therapy. Giving radiation treatment alone may be the same as the usual approach for controlling the cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy.

In patients with a higher gene risk score, researchers are comparing radiation therapy and hormone therapy with and without the addition of darolutamide. Darolutamide blocks the actions of prostate cancer-fueling hormones like testosterone in tumor cells and in the body. The addition of darolutamide to the usual treatment may be more effective for controlling the cancer and preventing it from spreading.

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have unfavorable intermediate-risk prostate cancer that has not yet been treated.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.


For more information about this study and to inquire about eligibility, please contact Dr. Sean McBride at 646-608-2450.




Phase III (phase 3)

Disease Status

Newly Diagnosed & Relapsed/Refractory


Co-Investigators ID