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

St. Joseph's Healthcare Hamilton

Status and phase

Withdrawn

Phase 3

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Sirolimus (Rapamune)

Drug: Cyclosporin (Neoral) or Tacrolimus (Prograf)

Study type

Interventional

Funder types

Other

Identifiers

NCT00922129

IIS-002-09

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.