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A Prospective Randomized Pilot Study Examining the Role and Effectiveness of Conversion to Sirolimus Versus CNI Reduction in Renal Transplant Patients With Prostate Cancer


Phase 2/Phase 3
18 Years
50 Years
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Prospective Randomized Pilot Study Examining the Role and Effectiveness of Conversion to Sirolimus Versus CNI Reduction in Renal Transplant Patients With Prostate Cancer


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Malignancy-free survival

Outcome Time Frame:

Months 3, 9, 15, 21

Safety Issue:

No

Principal Investigator

Anil Kapoor, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

McMaster Institute of Urology, McMaster University

Authority:

Canada: Health Canada

Study ID:

IIS-002-09

NCT ID:

NCT00922129

Start Date:

September 2009

Completion Date:

January 2011

Related Keywords:

  • Prostate Cancer
  • Sirolimus
  • Calcineurin inhibitor
  • prostate cancer
  • Prostatic Neoplasms

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