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ACTIVE NOT RECRUITING 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

NCT04513717 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 2,753 participants
Start Date 2021-01-21
Est. Completion 2033-12-31
Phase Phase 3

Sponsor

NRG Oncology

162 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04513717

The ClinicalTrials.gov registry entry for NCT04513717 describes a study currently listed as active not 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 2,753 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 3 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection 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: NCT04513717 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Alaska. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04513717?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial