NCT05404139

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
DRUG	Enzalutamide	Second-generation androgen pathway inhibitor (ARAT), oral tablet
OTHER	Standard of Care SBRT and ADT	Standard of care stereotactic body radiation therapy (SBRT) and androgen deprivation therapy (ADT)

Timeline

• Start date: 2023-05-24
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2022-06-03
• Last updated: 2024-11-25

Locations

2 sites across 1 country: Canada