Back to resultsEffectiveness of Conversion to Sirolimus Versus Calcineurin Inhibitor (CNI) Reduction in Renal Transplant Patients With Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Sirolimus (Rapamune)
Cyclosporin (Neoral) or Tacrolimus (Prograf)
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Sirolimus, Calcineurin inhibitor, prostate cancer
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.
Sites / Locations
- McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Conversion to sirolimus
Calcineurim inhibitor reduction
Arm Description
Outcomes
Primary Outcome Measures
Malignancy-free survival
Secondary Outcome Measures
Renal function as measured by serum creatinine and calculated creatinine clearance (using the formula of Cockcroft-Gault)
Testosterone levels
Quality of life
Full Information
NCT ID
NCT00922129
First Posted
June 16, 2009
Last Updated
January 13, 2014
Sponsor
St. Joseph's Healthcare Hamilton
1. Study Identification
Unique Protocol Identification Number
NCT00922129
Brief Title
Effectiveness of Conversion to Sirolimus Versus Calcineurin Inhibitor (CNI) Reduction in Renal Transplant Patients With Prostate Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Study did not start up as planned.
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
January 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
St. Joseph's Healthcare Hamilton
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Sirolimus, Calcineurin inhibitor, prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conversion to sirolimus
Arm Type
Experimental
Arm Title
Calcineurim inhibitor reduction
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sirolimus (Rapamune)
Other Intervention Name(s)
RAPAMUNE
Intervention Description
Started at 5 mg (Target levels 6-10mg/mL), Daily, PO, 24 months
Intervention Type
Drug
Intervention Name(s)
Cyclosporin (Neoral) or Tacrolimus (Prograf)
Other Intervention Name(s)
Cyclosporin: NEORAL, Tacrolimus: PROGRAF
Intervention Description
Cyclosporin: 3-4 mg/kg, BID, PO, 24 months
Tacrolimus: 0-.038-0.045 mg/kg, BID, PO, 24 months
Primary Outcome Measure Information:
Title
Malignancy-free survival
Time Frame
Months 3, 9, 15, 21
Secondary Outcome Measure Information:
Title
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
Title
Testosterone levels
Time Frame
Months 6, 12, 18 and 24
Title
Quality of life
Time Frame
Months 6, 12, 18 and 24
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Kapoor, MD
Organizational Affiliation
McMaster Institute of Urology, McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Conversion to Sirolimus Versus Calcineurin Inhibitor (CNI) Reduction in Renal Transplant Patients With Prostate Cancer
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