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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-100
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

Qualifiers

Age > 18 years

Able to provide informed consent

Histologic diagnosis of prostate adenocarcinoma

ECOG performance status 0-2

Disqualifiers

Significant comorbidities rendering patient not suitable for ADT, enzalutamide and SBRT

History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively

Prior use of salvage systemic therapy

Evidence of spinal cord compression

Trial design

Treatments tested in this trial

  • Enzalutamide
  • Standard of Care SBRT and ADT

Treatment groups

132 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Health Network, Toronto

Lead sponsor

Astellas Pharma Inc

Collaborator