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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00922129
Recruitment Status : Withdrawn (Study did not start up as planned.)
First Posted : June 17, 2009
Last Update Posted : January 14, 2014
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Sirolimus (Rapamune) Drug: Cyclosporin (Neoral) or Tacrolimus (Prograf) Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Pilot Study Examining the Role and Effectiveness of Conversion to Sirolimus Versus CNI Reduction in Renal Transplant Patients With Prostate Cancer
Study Start Date : September 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Conversion to sirolimus Drug: Sirolimus (Rapamune)
Started at 5 mg (Target levels 6-10mg/mL), Daily, PO, 24 months
Other Name: 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

Primary Outcome Measures :
  1. Malignancy-free survival [ Time Frame: Months 3, 9, 15, 21 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Testosterone levels [ Time Frame: Months 6, 12, 18 and 24 ]
  3. Quality of life [ Time Frame: Months 6, 12, 18 and 24 ]

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00922129

Canada, Ontario
McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Principal Investigator: Anil Kapoor, MD McMaster Institute of Urology, McMaster University

Responsible Party: Dr Anil Kapoor, McMaster Institute of Urology, McMaster University Identifier: NCT00922129     History of Changes
Other Study ID Numbers: IIS-002-09
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014

Keywords provided by St. Joseph's Healthcare Hamilton:
Calcineurin inhibitor
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Calcineurin Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents