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RECRUITING
NCT05404139
PHASE2

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

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2023-05-24

Completion Date

2026-03

Last Updated

2024-11-25

Healthy Volunteers

No

Interventions

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)

Locations (2)

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Sunnybrook Research Institute

Toronto, Ontartio, Canada