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

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

Status

Withdrawn

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00922129

Enrollment

Registered

2009-06-17

Start date

2009-09-30

Completion date

2011-01-31

Last updated

2014-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Sirolimus, Calcineurin inhibitor, prostate cancer

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.

Interventions

DRUGSirolimus (Rapamune)

Started at 5 mg (Target levels 6-10mg/mL), Daily, PO, 24 months

DRUGCyclosporin (Neoral) or Tacrolimus (Prograf)

Cyclosporin: 3-4 mg/kg, BID, PO, 24 months Tacrolimus: 0-.038-0.045 mg/kg, BID, PO, 24 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame
Malignancy-free survival	Months 3, 9, 15, 21

Secondary

Measure	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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026