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

NCT ID: NCT00922129

Last Updated: 2014-01-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-01-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conversion to sirolimus

Group Type: EXPERIMENTAL

Sirolimus (Rapamune)

Intervention Type: DRUG

Started at 5 mg (Target levels 6-10mg/mL), Daily, PO, 24 months

Calcineurim inhibitor reduction

Group Type: ACTIVE_COMPARATOR

Cyclosporin (Neoral) or Tacrolimus (Prograf)

Intervention Type: DRUG

Cyclosporin: 3-4 mg/kg, BID, PO, 24 months

Tacrolimus: 0-.038-0.045 mg/kg, BID, PO, 24 months

Interventions

Sirolimus (Rapamune)

Started at 5 mg (Target levels 6-10mg/mL), Daily, PO, 24 months

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

RAPAMUNE; Cyclosporin: NEORAL; Tacrolimus: PROGRAF

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

McMaster Institute of Urology, McMaster University

Principal Investigators

Anil Kapoor, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster Institute of Urology, McMaster University

Locations

McMaster Institute of Urology - St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

IIS-002-09

Identifier Type: -

Identifier Source: org_study_id