Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Darolutamide
- DRUG Bicalutamide
- DRUG Degarelix
- DRUG Buserelin
- DRUG Flutamide
Study Locations (20)
California
- Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn
- AIS Cancer Center at San Joaquin Community Hospital — Bakersfield
- Tower Cancer Research Foundation — Beverly Hills
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park
- City of Hope Corona — Corona
- City of Hope Comprehensive Cancer Center — Duarte
- Kaiser Permanente Dublin — Dublin
- UC San Diego Health System - Encinitas — Encinitas
- Kaiser Permanente-Fremont — Fremont
- Washington Hospital — Fremont
- Kaiser Permanente Fresno Orchard Plaza — Fresno
- Kaiser Permanente-Fresno — Fresno
Arizona
- Banner MD Anderson Cancer Center — Gilbert
- Arizona Center for Cancer Care - Gilbert — Gilbert
- Arizona Center for Cancer Care-Peoria — Peoria
- Arizona Center for Cancer Care - Phoenix — Phoenix
- Arizona Center for Cancer Care - Scottsdale — Scottsdale
- Arizona Center for Cancer Care-Surprise — Surprise
Alabama
- University of Alabama at Birmingham Cancer Center — Birmingham
Arkansas
- University of Arkansas for Medical Sciences — Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,050 participants |
| Start Date | 2021-12-06 |
| Est. Completion | 2026-11-11 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05050084
The ClinicalTrials.gov registry entry for NCT05050084 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,050 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NRG Oncology, which has 162 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions — of which Darolutamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05050084 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05050084 about?
NCT05050084 is a clinical study titled "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 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 ...
What is the current status of trial NCT05050084?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 2,050 participants. The study started on 2021-12-06. Estimated completion is 2026-11-11.
What conditions does trial NCT05050084 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05050084?
The interventions under investigation include: Darolutamide (DRUG), Bicalutamide (DRUG), Degarelix (DRUG), Buserelin (DRUG), Flutamide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05050084?
This trial is sponsored by NRG Oncology, which has 162 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05050084 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.