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.
Age > 18 years
Able to provide informed consent
Histologic diagnosis of prostate adenocarcinoma
ECOG performance status 0-2
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
Parallel
Enzalutamide
DrugSecond-generation androgen pathway inhibitor (ARAT), oral tablet
Standard of Care SBRT and ADT
Other interventionStandard of care stereotactic body radiation therapy (SBRT) and androgen deprivation therapy (ADT)
Progression free survival
Determine if progression free survival improves with the addition of intermittent enzalutamide to standard of care treatment.
Patient-reported quality of life
Determine if the addition of intermittent enzalutamide to standard of care treatment results in a patient-reported quality of life difference compared to standard of care treatment alone using quality of life questionnaires (EPIC-26).
Patient-reported quality of life
Determine if the addition of intermittent enzalutamide to standard of care treatment results in a patient-reported quality of life difference compared to standard of care treatment alone using quality of life questionnaires (FACT-P).
Patient-reported quality of life
Determine if the addition of intermittent enzalutamide to standard of care treatment results in a patient-reported quality of life difference compared to standard of care treatment alone using quality of life questionnaires (FACT-Fatigue).
Physician-reported toxicity
Determine if the addition of intermittent enzalutamide to standard of care treatment results in a physician-reported difference in acute and late toxicities compared to standard of care treatment alone assessed by CTCAE Toxicity 5.0.
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University Health Network, Toronto
Lead sponsor
Astellas Pharma Inc
Collaborator
