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.
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, ARPI (enzalutamide or abiraterone) 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
Abiraterone
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)
Atorvastatin
DrugLipid metabolism regulator
Progression free survival
Determine if progression free survival improves with the addition of short-term ARPI (abiraterone or abiraterone) with or without statin (atorvastatin) to standard of care treatment.
Patient-reported quality of life
Determine if the addition of short-term ARPI (abiraterone or enzalutamide) with or without statin (atorvastatin) 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 short-term ARPI (abiraterone or enzalutamide) with or without statin (atorvastatin) 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 short-term ARPI (abiraterone or enzalutamide) with or without statin (atorvastatin) 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.
Time to Testosterone Recovery
Determine time to testosterone recovery with the use of standard of care treatment, with or without ARPI (abiraterone or enzalutamide).
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University Health Network, Toronto
Lead sponsor
Astellas Pharma Inc
Collaborator
