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

This study is looking for men aged 18 or older who have been diagnosed with prostate cancer that doctors describe as 'unfavourable intermediate risk'. This means your cancer hasn't spread beyond your prostate, but it has certain characteristics that put it at a medium risk level. For example, your PSA level might be between 10 and 20, or your prostate exam/scan might show a specific size/location (T2b-c), or your Gleason score is 7 (which describes how aggressive the cancer cells look under a microscope).

To be considered for the study, you must have some 'unfavourable' features within this intermediate risk group. This could mean having more than one intermediate risk factor, or a specific Gleason score (4+3=7), or having cancer in 50% or more of the biopsy samples taken from your prostate. It's important that tests have confirmed your cancer has not spread to your bones or other parts of your body.

You would need to have had your prostate cancer diagnosed within the last 9 months, and recent scans and tests to confirm the stage of your cancer. Your doctor will carefully review all your medical information, including your biopsy results and scans, to see if you meet all the necessary requirements for this study.

If you decide to take part in this study, your journey will depend on your Decipher gene score. First, you'll have some initial tests, including a blood test to help determine your Decipher score. Once your score is known, you'll be assigned to one of two main groups based on whether your score is lower or higher.

If you have a lower Decipher score, you'll either receive radiation therapy alone or the standard treatment of radiation therapy plus 6 months of hormone therapy. If you have a higher Decipher score, you'll either receive the standard treatment (radiation therapy plus 6 months of hormone therapy) or the standard treatment with an additional drug, darolutamide.

All treatments involve regular visits for radiation sessions and monitoring. If you receive hormone therapy or darolutamide, you'll take these medications for a set period. After your main treatment, you'll have follow-up appointments to check on your health and the cancer. These check-ups will involve blood tests to measure your PSA (prostate specific antigen) and possibly scans. The total duration of active treatment will vary depending on your assigned group, but follow-up will continue for several years to track your progress.