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 (NCT05050084)
Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (576 Sites)
Showing the first 25 of 576 sites.
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- Arizona Center for Cancer Care - Gilbert — Gilbert, Arizona
- Arizona Center for Cancer Care-Peoria — Peoria, Arizona
- Arizona Center for Cancer Care - Phoenix — Phoenix, Arizona
- Arizona Center for Cancer Care - Scottsdale — Scottsdale, Arizona
- Arizona Center for Cancer Care-Surprise — Surprise, Arizona
- University of Arkansas for Medical Sciences — Little Rock, Arkansas
- Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California
- AIS Cancer Center at San Joaquin Community Hospital — Bakersfield, California
- Tower Cancer Research Foundation — Beverly Hills, California
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California
- City of Hope Corona — Corona, California
- City of Hope Comprehensive Cancer Center — Duarte, California
- Kaiser Permanente Dublin — Dublin, California
- UC San Diego Health System - Encinitas — Encinitas, California
- Kaiser Permanente-Fremont — Fremont, California
- Washington Hospital — Fremont, California
- Kaiser Permanente Fresno Orchard Plaza — Fresno, California
- Kaiser Permanente-Fresno — Fresno, California
- Marin General Hospital — Greenbrae, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California
- City of Hope at Irvine Lennar — Irvine, California
- UC San Diego Moores Cancer Center — La Jolla, California
- City of Hope Antelope Valley — Lancaster, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Prostate Adenocarcinoma
- Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial — Phoenix, Arizona
- Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer — Houston, Texas
- Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for Screening Prostate Cancer — Houston, Texas
- Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer — Bethesda, Maryland
- Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer — Houston, Texas
- PSMA PET Imaging of Recurrent Prostate Cancer — Basking Ridge, New Jersey
Explore by condition: All Prostate Adenocarcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.