This trial will investigate the activity of dasatinib plus LHRH analogue therapy in high-risk localized prostate cancer.
OUTLINE: This is a multi-center study. * Dasatinib -100 mg administered once daily per oral route for 28 consecutive days. * Leuprolide acetate - 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days). The 28 days of dasatinib and leuprolide injection (plus the time required to recover from toxicity if encountered) is defined as a cycle. Patients will be treated for up to a maximum of 3 cycles of dasatinib and leuprolide acetate. Radical Prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Hematopoietic: * Hemoglobin (Hgb) ≥ 8.0 g/dL * Platelets ≥ 100 K/mm3 * Absolute neutrophil count (ANC) ≥ 1.0 K/mm3 Hepatic: * Total bilirubin \< 2.0 X Upper Limit Normal (ULN) * Aspartate aminotransferase (AST) \< 2.5 X ULN * Alanine aminotransferase (ALT) \< 2.5 X ULN Renal: * Calculated creatinine clearance of ≥ 60 cc/min using the Cockcroft-Gault formula Cardiovascular: * No uncontrolled angina, congestive heart failure or myocardial infarction within 6 months prior to registration for protocol therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Dasatinib 100 mg administered once daily per oral route for 28 consecutive days
Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).
Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.
Mayo Clinic Hospital
Scottsdale, Arizona, United States
University of Florida
Gainesville, Florida, United States
University of Chicago
Chicago, Illinois, United States
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States
To Estimate the Pathologic Complete Response (pCR) Rate
Time frame: 18 months
To Estimate Partial Pathologic Responses (pPR)
Time frame: 18 months
To Estimate PSA Response Rate
Time frame: 18 months
To Estimate Progression Free Survival
Time frame: 18 months
To Evaluate the Impact of Dasatinib Plus LHRH on Expression of Selected Biomarkers
Time frame: 18 months
To Estimate Safety and Tolerability of LHRH Plus Dasatinib
Time frame: 18 months
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Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Virginia Oncology Associates
Norfolk, Virginia, United States