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

Study Overview
=================
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.

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Sirolimus (Rapamune)
* Drug: Cyclosporin (Neoral) or Tacrolimus (Prograf)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conversion to sirolimus<br> | Drug: Sirolimus (Rapamune)<br>* Started at 5 mg (Target levels 6-10mg/mL), Daily, PO, 24 months<br>* Other names: RAPAMUNE;|
| Active Comparator: Calcineurim inhibitor reduction<br> | Drug: Cyclosporin (Neoral) or Tacrolimus (Prograf)<br>* Cyclosporin: 3-4 mg/kg, BID, PO, 24 months Tacrolimus: 0-.038-0.045 mg/kg, BID, PO, 24 months<br>* Other names: Tacrolimus: PROGRAF;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malignancy-free survival |  | Months 3, 9, 15, 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Testosterone levels |  | Months 6, 12, 18 and 24 | 
| Quality of life |  | Months 6, 12, 18 and 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sirolimus, Calcineurin inhibitor, prostate cancer