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NCT04513717 · ClinicalTrials.gov registry record · Phase 3
Two Studies for Patients With High 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 High Gene Risk Score, The PREDICT-RT Trial
A Phase 3 study of Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8, sponsored by NRG Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 2,753
- Enrollment target
- 20
- Study locations
NCT04513717: Active Phase 3 study of Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8, sponsored by NRG Oncology.
NCT04513717 is a Phase 3 study of Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8 that is active but no longer recruiting, run by NRG Oncology. The registered enrollment target is 2,753 participants, above the 191-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (1341% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04513717, a Phase 3 study of Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8, is active but no longer recruiting, sponsored by NRG Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 2,753 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.
Primary Outcome
Assessed based on conventional imaging. MFS will be estimated using the Kaplan-Meier method (Kaplan 1958).
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Scan
- DRUG Apalutamide
- DRUG Bicalutamide
- DRUG Buserelin
Study Locations (20)
California
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- AIS Cancer Center at San Joaquin Community Hospital - Bakersfield
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
- Enloe Medical Center - Chico
- 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
- Palo Alto Medical Foundation-Fremont - Fremont
- Washington Hospital - Fremont
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
- University of Arizona Cancer Center-North Campus - Tucson
Alaska
- Fairbanks Memorial Hospital - Fairbanks
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,753 participants |
| Start Date | 2021-01-21 |
| Est. Completion | 2033-12-31 |
| Phase | Phase 3 |
What the registry record for NCT04513717 still lists
NCT04513717 is an interventional study that assigns participants to a tested intervention. Its 2,753 participants enrollment target places it among the larger protocols in the corpus, above the 191-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (1341% higher).
The record links to 3 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04513717 names 20 study sites across 4 states, led by California, Arizona, Alaska.
Frequently Asked Questions
What is clinical trial NCT04513717 about?
NCT04513717 is a clinical study titled "Two Studies for Patients With High 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 High Gene Risk Score, The PREDICT-RT Trial". This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone th...
What is the current status of trial NCT04513717?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 2,753 participants. The study started on 2021-01-21. Estimated completion is 2033-12-31.
What conditions does trial NCT04513717 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8.
What interventions are being tested in trial NCT04513717?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Scan (PROCEDURE), Apalutamide (DRUG), Bicalutamide (DRUG), Buserelin (DRUG).
Who is sponsoring clinical trial NCT04513717?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04513717 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04513717's enrollment target sits among peer trials
2,753 1st of 99 higher than 99 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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