Genomic testing speeds patient accrual in high-risk prostate cancer trial

The NRG Oncology NRG-GU009 (PREDICT-RT) study evaluating intensified and de-intensified concurrent radiation regimens based on the genomic risk of patients with high-risk prostate cancer completed accrual and met its accrual milestone of 2,478 patients approximately two years earlier than the trial's anticipated accrual completion date.

The incidence of men receiving high-risk prostate cancer diagnoses is on the increase in recent years. The PREDICT-RT study was designed to improve quality of life and outcomes for these patients while tailoring treatments to meet each individual's needs based on their Decipher Prostate Genomic Classifier scores which use the tumor's genomic information to predict aggressiveness."

Paul Nguyen, MD MBA, Mass General Brigham

Paul Nguyen is also associated with the Dana Farber Cancer Centers and the Principal Investigator of the PREDICT-RT study.

The PREDICT-RT study stratifies enrolled patients with high-risk cancer by Decipher Risk Score. Decipher testing was conducted by Veracyte, Inc. (VCYT), a global diagnostics company that provides high-performing cancer genomic testing and also participates extensively in clinical research around prostate cancer. The Decipher Risk Score was used to determine if a patient should be assigned to the de-intensification cohort or the intensification cohort.

Patients with a Decipher score of less than or equal to 0.85 were assigned to the De-Intensification study. Patients on the De-Intensification study were stratified by Decipher score range, boost type, prior pelvic treatment, and ACE-27 comorbidity. Following stratification, patients on the De-intensification study were randomly assigned to treatment arm 1 or arm 2. Patients on treatment arm 1 received the standard of care for this type of cancer which includes radiotherapy (RT) and 24 months of androgen deprivation therapy (ADT). Patients on treatment arm 2 received RT and 12 months of ADT.

Patients with a Decipher score greater than 0.85 or node positive disease were assigned to the Intensification study. Patients on the Intensification study were stratified by boost type, prior pelvic treatment, and nodal status. Following stratification, patients on the Intensification study were randomly assigned to treatment arm 3 or arm 4. Patients on treatment arm 3 received the standard of care RT with 24 months of ADT, whereas patients on treatment arm 4 received RT, 24 months of ADT, and 24 months of apalutamide.

The primary objective of the De-intensification study is to determine if men with high-risk prostate cancer in a lower Decipher score range can be treated with less ADT and achieve metastasis-free survival results not worse than standard ADT. The primary objective of the Intensification study is to determine if the addition of apalutamide to the standard of care can help improve metastasis-free survival for men with high-risk prostate cancer in a higher Decipher score range.

"Our study team would like to thank our sites and our patients who quickly enrolled to this very important trial. We look forward to reporting the results as data becomes available from this trial," added Oliver Sartor, MD, of East Jefferson General Hospital and the co-Principal Investigator of the PREDICT-RT study.