The purpose of this study is to evaluate the role and effectiveness of conversion to sirolimus versus CNI reduction in renal transplant patients with prostate cancer.
This study is designed to support the optimal use of mTOR-inhibitor by providing data for the safe and effectiveness use with sirolimus. This study will take into account effectiveness aspects such as malignancy-free survival cancer by reducing the overall exposure to calcineurin inhibitor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Started at 5 mg (Target levels 6-10mg/mL), Daily, PO, 24 months
Cyclosporin: 3-4 mg/kg, BID, PO, 24 months Tacrolimus: 0-.038-0.045 mg/kg, BID, PO, 24 months
McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Malignancy-free survival
Time frame: Months 3, 9, 15, 21
Renal function as measured by serum creatinine and calculated creatinine clearance (using the formula of Cockcroft-Gault)
Time frame: Weeks 1, 3, 6, Months 3, 6, 9, 12, 15, 18, 21 and 24
Testosterone levels
Time frame: Months 6, 12, 18 and 24
Quality of life
Time frame: Months 6, 12, 18 and 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.