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

St. Joseph's Healthcare Hamilton1 site in 1 countrySeptember 2009

ConditionsProstate Cancer

InterventionsSirolimus (Rapamune)Cyclosporin (Neoral) or Tacrolimus (Prograf)

DrugsSirolimus (Rapamune)Cyclosporin (Neoral) or Tacrolimus (Prograf)

Overview

Phase: Phase 2
Intervention: Sirolimus (Rapamune)
Conditions: Prostate Cancer
Sponsor: St. Joseph's Healthcare Hamilton
Locations: 1
Primary Endpoint: Malignancy-free survival
Status: Withdrawn
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

January 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

St. Joseph's Healthcare Hamilton

Eligibility Criteria

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.

Arms & Interventions

Conversion to sirolimus

Intervention: Sirolimus (Rapamune)

Calcineurim inhibitor reduction

Intervention: Cyclosporin (Neoral) or Tacrolimus (Prograf)

Outcomes

Primary Outcomes

Malignancy-free survival

Time Frame: Months 3, 9, 15, 21

Secondary Outcomes

Quality of life(Months 6, 12, 18 and 24)
Renal function as measured by serum creatinine and calculated creatinine clearance (using the formula of Cockcroft-Gault)(Weeks 1, 3, 6, Months 3, 6, 9, 12, 15, 18, 21 and 24)
Testosterone levels(Months 6, 12, 18 and 24)