Sirolimus Before Surgery in Treating Patients With Advanced Localized Prostate Cancer
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring stage III prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, adenocarcinoma of the prostate
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically determined adenocarcinoma of the prostate Stage T1c-T3b disease No evidence of disease that has spread beyond the prostate or seminal vesicles No metastatic prostate cancer, including bone, visceral, brain, and lymph node metastases Tumor Gleason score sum of 7-10 (4+3 and 3+4 allowed) with tumor involving at least 2 discrete core biopsy sections Scheduled to undergo radical prostatectomy No other subtypes of prostate cancer, including any of the following: Sarcoma Neuroendocrine tumors Small cell cancer Ductal cancer Lymphoma PATIENT CHARACTERISTICS: ECOG performance status 0-1 WBC > 3,500/mm^3 Absolute neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hemoglobin > 9 g/dL Creatinine < 2.0 mg/dL Bilirubin < 2 mg/dL ALT and AST < 2 times upper limit of normal (ULN) Alkaline phosphatase < 2 times ULN Triglycerides and total cholesterol < 2 times ULN No history of allergy to sirolimus (rapamycin) or its derivatives No uncontrolled medical condition that would increase risk or limit compliance with study requirements, including the following: Immunodeficiency Gastrointestinal disease that would limit ability to swallow, take oral medications, or absorb them No active infections No other concurrent malignancy PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior chemotherapy, biologic therapy, radiotherapy, or immunotherapy for prostate cancer No concurrent chronic treatment with immunosuppressants or medications that interfere with the metabolism of sirolimus (rapamycin) No concurrent medication or agents that would interfere with the metabolism or excretion of rapamycin or its derivatives, including any of the following: Phenytoin Carbamazepine Cyclosporine Clarithromycin Clotrimazole Erythromycin Amiodarone Protease inhibitors used to treated HIV infection Cisapride Grapefruit juice Diltiazem Tacrolimus Hypericum perforatum (St. John's wort) Barbiturates Rifampin Phenobarbital Rifabutin Efavirenz Nevirapine At least 7 days since prior herbal medicines and medications, including any of the following: Hydrastis canadensis (goldenseal) Uncaria tomentosa (cat's claw) Echinacea angustifolia roots Trifolium pretense (wild cherry) Chamomile Glycyrrhiza glabra (licorice) Dillapiol Naringenin Norfloxacin Atorvastatin Pravastatin Cimetidine Fluconazole
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- University of Michigan Comprehensive Cancer Center
- Duke Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Control group
Low-dose Rapamycin (3mg)
High-dose Rapamycin (6mg)
Men >18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy. Receive no intervention on Days 1-14. Surgery performed on Day 15.
Men >18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy. Must have adequate hepatic, renal and bone marrow function, no allergy to rapamycins, avoid medications interfering with rapamycin metabolism, no active infection, no prior therapies for prostate cancer. Will receive rapamycin 3mg (Wyeth Pharmaceuticals, 1mg tablets) oral (PO) once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).
Men >18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy. Must have adequate hepatic, renal and bone marrow function, no allergy to rapamycins, avoid medications interfering with rapamycin metabolism, no active infection, no prior therapies for prostate cancer. Will receive rapamycin 6mg (Wyeth Pharmaceuticals, 2mg tablets) oral (PO) once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).