Effectiveness of Conversion to Sirolimus Versus Calcineurin Inhibitor (CNI) Reduction in Renal Transplant Patients With Prostate Cancer

A Prospective Randomized Pilot Study Examining the Role and Effectiveness of Conversion to Sirolimus Versus CNI Reduction in Renal Transplant Patients With Prostate Cancer

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.

Inclusion Criteria:

• Male patients ≤ 50 years in their post renal transplant follow-up;
• Biopsy confirmed prostate cancer;
• Stable renal function with GFR ≥ 40 mL/min.

Exclusion Criteria:

• Patients with metastatic disease;
• Uncontrolled hyperlipidemia;
• Proteinuria > 500 mg/day;
• Biopsy evidence of acute rejection within the past 3 months;
• Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator might significantly alter the absorption, distribution, metabolism or excretion of study medication;
• Patients with mental illness;
• Inability to cooperate or communicate with the investigator or unable to complete self administered questionnaires.