Metastatic Prostate Cancer
Conditions
Brief summary
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.
Interventions
DRUGAbiraterone
Second-generation androgen pathway inhibitor (ARAT), oral tablet
OTHERStandard of Care SBRT and ADT
Standard of care stereotactic body radiation therapy (SBRT) and androgen deprivation therapy (ADT)
DRUGAtorvastatin
Lipid metabolism regulator
Sponsors
University Health Network, Toronto
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years 2. Able to provide informed consent 3. Histologic diagnosis of prostate adenocarcinoma 4. ECOG performance status 0-2 5. Stage IV castrate sensitive metachronous metastatic prostate cancer. diagnosed within 6 months of study enrollment with 1-10 metastases 1. Maximum one metastatic deposit on conventional imaging (CT or bone scan or MR) 2. Additional metastases can be detectable by PSMA PET only 6. All sites of disease are amenable to and can be safely treated with radiotherapy 7. Patients decline continuous use of ADT
Exclusion criteria
(for all patients): 1. Significant comorbidities rendering patient not suitable for ADT, ARPI (enzalutamide or abiraterone) and SBRT a. Patients with significant comorbidities rendering patient not suitable for atorvastatin is not an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported quality of life | 5 years | 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). |
| Physician-reported toxicity | 5 years | 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 | 5 years | Determine time to testosterone recovery with the use of standard of care treatment, with or without ARPI (abiraterone or enzalutamide). |
| Improvement in Metabolic Parameters | 5 years | Determine if a statin (atorvastatin) with short-term ARPI (abiraterone) and standard of care treatment results in improved metabolic parameters (e.g. lipid profile, fasting glucose) and lower occurrence of cardiovascular events compared to short-term ARPI and standard of care treatment, alone. |
| Circulating Cell-Free DNA | 2 years | Determine if a statin (atorvastatin) with short-term ARPI (abiraterone) and standard of care treatment results in lower levels of circulating cell-free DNA compared to short-term ARPI and standard of care treatment, alone. |
Countries
Canada
Contacts
CONTACTRachel Glicksman, MD
Outcome results
None listed