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

This study has been withdrawn prior to enrollment.
(Study did not start up as planned.)
Sponsor:
Information provided by:
St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT00922129
First received: June 16, 2009
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • Malignancy-free survival [ Time Frame: Months 3, 9, 15, 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Testosterone levels [ Time Frame: Months 6, 12, 18 and 24 ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: Months 6, 12, 18 and 24 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: September 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922129

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

No publications provided

Responsible Party: Dr Anil Kapoor, McMaster Institute of Urology, McMaster University
ClinicalTrials.gov Identifier: NCT00922129     History of Changes
Other Study ID Numbers: IIS-002-09
Study First Received: June 16, 2009
Last Updated: March 6, 2012
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Cyclosporins
Cyclosporine
Sirolimus
Everolimus
Tacrolimus
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 19, 2013