Prostate Cancer GU009 (PREDICT-RT)

Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*) *Prostate RNA Expression/Decipher To Individualize Concurrent Therapy with Radiation

Summary:

De-Intensification Study: To determine whether men with NCCN high risk prostate cancer who are in the lower 2/3 of Decipher genomic risk (< 0.85) can be treated with 12 months ADT plus RT instead of 24 months ADT+RT and experience non-inferior metastasis-free survival.

Intensification Study: To determine whether men with NCCN high risk prostate cancer who are in the upper 1/3 of Decipher genomic risk (>0.85) or have node-positive disease by conventional imaging (MRI or CT scan) will have a suprior metastasis-free survival (MFS) through treatment intensification with apalutamide added to the standard of RT plus 24 month ADT.

Key Inclusion Criteria:

• Pathologically proven diagnosis of adenocarcinoma of prostate cancer within 180 days prior to registration.
• High-risk disease defined as having at least one of the following:
  • PSA >20 ng/mL prior to starting ADT
  • cT3a-T4 by digital exam or imaging (AJCC 8thEd.)
  • Gleason Score of 8-10
  • Node positive by conventional imaging with a short axis of at least 1.0 cm
• ECOG Performance Status 0-2

Primary Study Contact: Sierra Irizarry 860-972-4062

Research procedures may be conducted at the following locations: Hartford Hospital and St. Vincent’s Medical Center

Non-interventional study visits may take place at the following locations: HHC Medical Group at Avon and Manchester, Hospital of Central Connecticut, Midstate Medical Center