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

Phase 2

Withdrawn

• Conditions: Prostate Cancer
• Interventions: Drug: Cyclosporin (Neoral) or Tacrolimus (Prograf); Drug: Sirolimus (Rapamune)

• Registration Number: NCT00922129
• Lead Sponsor: St. Joseph's Healthcare Hamilton

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.

Study Timeline

• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-17
• Study Start: 2009-09
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-13
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcineurim inhibitor reduction	Cyclosporin (Neoral) or Tacrolimus (Prograf)	-
Conversion to sirolimus	Sirolimus (Rapamune)	-

Primary Outcome Measures

Name	Time	Method
Malignancy-free survival	Months 3, 9, 15, 21

Secondary Outcome Measures

Name	Time	Method
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
Quality of life	Months 6, 12, 18 and 24

Trial Locations

Locations (1)

McMaster Institute of Urology - St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada