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

NCT00922129 | Withdrawn Phase 2

• 1 other identifier: IIS-002-09
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Sirolimus; Calcineurin inhibitor; prostate cancer

Outcome Measures

Primary Outcomes (1)

• Malignancy-free survival

  Months 3, 9, 15, 21

Secondary Outcomes (3)

• 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

Study Arms (2)

Conversion to sirolimus

EXPERIMENTAL

Drug: Sirolimus (Rapamune)

Calcineurim inhibitor reduction

ACTIVE COMPARATOR

Drug: Cyclosporin (Neoral) or Tacrolimus (Prograf)

Interventions

Sirolimus (Rapamune) DRUG

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

Also known as: RAPAMUNE

Conversion to sirolimus

Cyclosporin (Neoral) or Tacrolimus (Prograf) DRUG

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

Also known as: Cyclosporin: NEORAL, Tacrolimus: PROGRAF

Calcineurim inhibitor reduction

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male patients ≤ 50 years in their post renal transplant follow-up;
• Biopsy confirmed prostate cancer;
• Stable renal function with GFR ≥ 40 mL/min.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

McMaster Institute of Urology - St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Sirolimus; Cyclosporine; Tacrolimus

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Anil Kapoor, MD

  McMaster Institute of Urology, McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

CA (1)