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

January 13, 2014 updated by: St. Joseph's Healthcare Hamilton

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • McMaster Institute of Urology - St. Joseph's Healthcare Hamilton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conversion to sirolimus
Drug: Sirolimus (Rapamune)
Started at 5 mg (Target levels 6-10mg/mL), Daily, PO, 24 months
Other Names:
  • RAPAMUNE
Active Comparator: Calcineurim inhibitor reduction
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

Other Names:
  • Cyclosporin: NEORAL
  • Tacrolimus: PROGRAF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Malignancy-free survival
Time Frame: Months 3, 9, 15, 21
Months 3, 9, 15, 21

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Healthcare Hamilton

Investigators

  • Principal Investigator: Anil Kapoor, MD, McMaster Institute of Urology, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

January 1, 2011

Study Completion (Anticipated)

January 1, 2011

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (Estimate)

June 17, 2009

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 13, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIS-002-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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