drugset / Trial / NCT04513717

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

Phase 3 Active not recruiting 2753 enrolled NRG Oncology National Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-01-21
Primary completion
2033-12-31
Completion
2033-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Apalutamide Small molecule Oral
Background Bicalutamide Other / unclassified
Background Degarelix Other / unclassified
Background Goserelin Other / unclassified
Background Histrelin Other / unclassified
Background Leuprolide Other / unclassified
Background Relugolix Small molecule
Background Triptorelin Other / unclassified
Background buserelin Unknown
Background flutamide Small molecule