NCT00922129

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

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: St. Joseph's Healthcare Hamilton · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Sirolimus (Rapamune)	Started at 5 mg (Target levels 6-10mg/mL), Daily, PO, 24 months
DRUG	Cyclosporin (Neoral) or Tacrolimus (Prograf)	Cyclosporin: 3-4 mg/kg, BID, PO, 24 months Tacrolimus: 0-.038-0.045 mg/kg, BID, PO, 24 months

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-06-17
• Last updated: 2014-01-14

Locations

1 site across 1 country: Canada