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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00922129
• Other study ID #: IIS-002-09
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: June 16, 2009
• Last updated: January 13, 2014
• Start date: September 2009
• Est. completion date: January 2011

Study information

• Verified date: January 2014
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Sirolimus (Rapamune)
Started at 5 mg (Target levels 6-10mg/mL), Daily, PO, 24 months
• 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

Locations

Country	Name	City	State
Canada	McMaster Institute of Urology - St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malignancy-free survival		Months 3, 9, 15, 21	No
Secondary	Renal function as measured by serum creatinine and calculated creatinine clearance (using the formula of Cockcroft-Gault)		Weeks 1, 3, 6, Months 3, 6, 9, 12, 15, 18, 21 and 24	Yes
Secondary	Testosterone levels		Months 6, 12, 18 and 24	Yes
Secondary	Quality of life		Months 6, 12, 18 and 24	Yes