PREDICT: Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial

Radiographic progression is defined by PCWG-3 for patients with bone metastases and modified RECIST 1.1 criteria for patients with soft tissue metastases. The 9-month radiographic progression-free proportion will be estimated by treatment arm, where patients who withdraw from study after the start of treatment but prior to nine months of follow-up will be counted as failures. rPFS will be calculated from registration date under progression or death by any cause, censoring event-free patients at the date of last disease evaluation. Will be estimated in each treatment arm using the Kaplan-Meier method.

Will be calculated from registration date until death due to any cause, censoring event-free patients at the date of last contact. Will be estimated in each treatment arm using the Kaplan-Meier method.

Will be estimated according to RECIST v1.1 for patients with measurable disease in each treatment arm using the cumulative incidence function.

Defined as greater than or equal to 50% decline in PSA from baseline using PCWG-3 criteria. Will be estimated as a proportion in each treatment arm.

A skeletal related event is defined as the use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumor related orthopedic surgical intervention. Will be estimated in each treatment arm using the cumulative incidence function.

Defined as time from registration to first subsequent anti-cancer therapy or death, censoring event-free patients at date of last follow-up. Will be estimated in each treatment arm using the cumulative incidence function.

Will be collected and graded according ot the NCI CTCAE v5.0 criteria and per PRO-CTCAE.

Will evaluate patient scores relative to clinician graded AEs.