Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)

This is a multi-centre, investigator-initiated, three-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor and atorvastatin to standard of care radiation and hormone therapy improve quality of life. Participants will either receive standard of care radiation and hormone (ADT) therapy (Arm 1), standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months (Arm 3) or standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months plus atorvastatin for 2 years (Arm 4). Participants will be routinely follow-up in clinic or remotely for up to 5 years.

NCT Number	NCT05404139
Lead Sponsor	University Health Network, Toronto Collaborators: Astellas Pharma Inc
Conditions	Metastatic Prostate Cancer
Enrollment	352 participants
Start Date	2023-05-24
Primary Completion	2031-02 (estimated)
Study Completion	2031-02 (estimated)
Updated on ClinicalTrials.gov	2026-07-27