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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

Exploring treatments for prostate cancer based on gene risk scores.

Recruiting
18 years and older
Male
Phase 3

This study looks at treating prostate cancer based on a Decipher risk score, which predicts if cancer is likely to spread. The Decipher risk score is calculated by looking at the activity of 22 genes in the prostate tumor. Patients with a low score might receive less intense treatment, like radiation therapy alone, which uses high energy to kill cancer cells. Those with a high score might get a more intense treatment, adding the drug darolutamide to regular hormone and radiation therapy. Hormone therapy drugs reduce or block male hormones that help prostate cancer grow.

  • The study lasts for 5 years, with follow-ups every few months.
  • Participants will be checked regularly to see if cancer spreads or comes back.
  • Possible side effects include those from radiation, hormone therapy, and darolutamide.

Consider joining if you are 18 or older, have prostate cancer, and meet specific health criteria. Avoid if you had prior prostate surgeries or treatments. Participating can help find better ways to treat prostate cancer based on personal risk scores.

Study details
    Prostate Adenocarcinoma

NCT05050084

NRG Oncology

17 May 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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