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

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.

Conditions

• Prostate Adenocarcinoma
• Stage III Prostate Cancer AJCC v8
• Stage IVA Prostate Cancer AJCC v8

Interventions

DRUG

Apalutamide

Given PO

DRUG

Bicalutamide

Given bicalutamide

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Scan

Undergo bone scan

DRUG

Buserelin

Given buserelin

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Degarelix

Given degarelix

DRUG

Flutamide

Given flutamide

DRUG

Goserelin

Given goserelin

DRUG

Histrelin

Given histrelin

DRUG

Leuprolide

Given leuprolide

PROCEDURE

Magnetic Resonance Elastography

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET scan

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Radiation Therapy

Undergo radiation therapy

DRUG

Relugolix

Given relugolix

DRUG

Triptorelin

Given triptorelin

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• NRG Oncology

  lead OTHER

Principal Investigators

• Paul L Nguyen · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-21

Primary Completion

2033-12-31

Completion

2033-12-31

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations