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Study did not start up as planned.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conversion to sirolimus | Experimental |
| |
| Calcineurim inhibitor reduction | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus (Rapamune) | Drug | Started at 5 mg (Target levels 6-10mg/mL), Daily, PO, 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Malignancy-free survival | Months 3, 9, 15, 21 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anil Kapoor, MD | McMaster Institute of Urology, McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster Institute of Urology - St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada |
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| 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 |
|
|
| Quality of life | Months 6, 12, 18 and 24 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D016572 | Cyclosporine |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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