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This study has been withdrawn prior to enrollment.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: January 13, 2014
Last verified: January 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: January 13, 2014
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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Cyclosporine
Cyclosporins
Everolimus
Sirolimus
Tacrolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014