Clinical Trial Details
Back to clinical trials
Phase IIIInterventional
A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients with Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response (TRIPLE-SWITCH)
Protocol: 2025P013570NCT: NCT06592924
Overview
Primary Objective:
1.1 Primary Objective
- To compare overall survival (OS) in participants with mCSPC who are receiving standard of care ADT (between 6-12 months exposure) + ARPI (> or = 4-months exposure) and have suboptimal PSA response (PSA > or = 0.2 ng/ml at enrollment) with those who receive standard of care ADT + ARPI plus docetaxel chemotherapy.
Secondary Objectives:
1.2 Secondary Objectives
- To compare both arms with respect to:
- PSA progression
- PSA response (PCWG3 criteria)
- PSA kinetics:
- 90% PSA decline
- PSA <0.2ng/ml
- PSA <0.02ng/ml
- Clinical progression free survival
Investigators
Locations
Emory University Hospital Midtown
Emory Saint Joseph's Hospital
Emory Johns Creek Hospital
Grady Health System
Winship Cancer Institute