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NCT05050084 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Prostate Adenocarcinoma, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 2,050
- Enrollment target
- 20
- Study locations
NCT05050084: Recruiting Phase 3 study of Prostate Adenocarcinoma, sponsored by NRG Oncology.
NCT05050084 is a Phase 3 study of Prostate Adenocarcinoma that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 2,050 participants, above the 198-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (935% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05050084, a Phase 3 study of Prostate Adenocarcinoma, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 2,050 participants
- Enrollment target
- 20
- Study locations
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 |
What NCT05050084 shows while recruiting
NCT05050084 is an interventional study that assigns participants to a tested intervention. Its 2,050 participants enrollment target places it among the larger protocols in the corpus, above the 198-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (935% higher).
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.
NCT05050084 names 20 study sites across 4 states, led by California, Arizona, Alabama.
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.
What interventions are being tested in trial NCT05050084?
The interventions under investigation include: Darolutamide (DRUG), Bicalutamide (DRUG), Degarelix (DRUG), Buserelin (DRUG), Flutamide (DRUG).
Who is sponsoring clinical trial NCT05050084?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
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
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Where NCT05050084's enrollment target sits among peer trials
2,050 2nd of 99 the highest of 99 other Prostate Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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