A Phase II Study of Neoadjuvant 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
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.
ECOG performance status 0 or 1
- Hemoglobin (Hgb) ≥ 8.0 g/dL
- Platelets ≥ 100 K/mm3
- Absolute neutrophil count (ANC) ≥ 1.0 K/mm3
- Total bilirubin < 2.0 X ULN
- Aspartate aminotransferase (AST) < 2.5 X ULN
- Alanine aminotransferase (ALT) < 2.5 X ULN
- Calculated creatinine clearance of ≥ 60 cc/min using the Cockcroft-Gault formula
- No uncontrolled angina, congestive heart failure or MI within 6 months prior to
registration for protocol therapy.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate the pathologic complete response (pCR) rate
Noah Hahn, M.D.
Hoosier Oncology Group
United States: Food and Drug Administration
|Virginia Oncology Associates||Newport News, Virginia 23606|
|Mayo Clinic Hospital||Phoenix, Arizona 85054-4502|
|University of Florida||Gainesville, Florida 32610-0277|
|University of Chicago||Chicago, Illinois 60637|
|Medical & Surgical Specialists, LLC||Galesburg, Illinois 61401|
|Indiana University Simon Cancer Center||Indianapolis, Indiana 46202|