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Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial
MinorTrial status changed: Recruiting → Active, Not RecruitingStudy sites: 575 to 576v23Show 1 more changeShow less
Study sites: 575 to 576
MinorStudy sites: 573 to 575v22
Show 20 earlier versionsHide 20 earlier versions
MinorStudy sites: 570 to 573v21
MinorStudy sites: 563 to 570v20
MinorStudy sites: 559 to 563v19
MinorStudy sites: 551 to 559v18
NotablePrimary completion date: Apr 30, 2032 to Nov 11, 2026Start date: Nov 3, 2021 to Dec 6, 2021 · Study sites: 541 to 551 · Completion date: Apr 30, 2037 to Nov 11, 2026 · 4 morev17Show 7 more changesShow less
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 5 · Start date changed from estimate of Nov 11, 2021 to Nov 3, 2021v3Show 2 more changesShow less
Study sites: 0 to 5
Start date changed from estimate of Nov 11, 2021 to Nov 3, 2021
MinorSecondary endpoints revised (12)Primary endpoints revised (2)v2Show 1 more changeShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trial uses the Decipher risk score to guide therapy selection. Decipher score is based on the activity of 22 genes in prostate tumor and may predict how likely it is for recurrent prostate cancer to spread (metastasize) to other parts of the body. Decipher score in this study is used for patient selection and the two variations of treatment to be studied: intensification for higher Decipher score or de-intensification for low Decipher score. Patients with higher Decipher risk score will be assigned to the part of the study that compares the use of 6 months of the usual treatment (hormone therapy and radiation treatment) to the use of darolutamide plus the usual treatment (intensification). The purpose of this section of the study is to determine whether the additional drug can reduce the chance of cancer coming back and spreading in patients with higher Decipher score. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading. Alternatively, patients with low Decipher risk score will be assigned to the part of the study that compares the use of radiation treatment alone (de-intensification) to the usual approach (6 months of hormone therapy plus radiation). The purpose of this part of the study is to determine if radiation treatment alone is as effective compared to the usual treatment without affecting the chance of tumor coming back in patients with low Decipher score prostate cancer. Radiation therapy uses high energy to kill tumor cells and reduce the tumor size. Hormone therapy drugs such as darolutamide suppress or block the production or action of male hormones that play role in prostate cancer development. Effect of radiation treatment alone in patients with low Decipher score prostate cancer could be the same as the usual approach in stabilizing prostate cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy.
Trial Details
NCT Number
NCT05050084
Lead Sponsor
NRG Oncology Collaborators: National Cancer Institute (NCI)