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 Flutamide Small molecule — —
Background Goserelin Other / unclassified — —
Background Histrelin Other / unclassified — —
Background Leuprolide Other / unclassified — —
Background Relugolix Small molecule — —
Background Triptorelin Other / unclassified — —
Background buserelin Unknown — —