Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00860158|
Recruitment Status : Terminated (Slow accrual; closed by funder)
First Posted : March 12, 2009
Results First Posted : February 5, 2016
Last Update Posted : March 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Dasatinib Drug: Leuprolide Acetate (LHRH Analogue) Procedure: Radical Prostatectomy||Phase 2|
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
- Hemoglobin (Hgb) ≥ 8.0 g/dL
- Platelets ≥ 100 K/mm3
- Absolute neutrophil count (ANC) ≥ 1.0 K/mm3
- Total bilirubin < 2.0 X Upper Limit Normal (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 myocardial infarction within 6 months prior to registration for protocol therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Experimental: Single Arm Assignment
Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy
Dasatinib 100 mg administered once daily per oral route for 28 consecutive days
Drug: Leuprolide Acetate (LHRH Analogue)
Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).
Procedure: Radical Prostatectomy
Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860158
|United States, Arizona|
|Mayo Clinic Hospital|
|Scottsdale, Arizona, United States, 85054|
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Medical & Surgical Specialists, LLC|
|Galesburg, Illinois, United States, 61401|
|United States, Indiana|
|Indiana University Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Virginia|
|Virginia Oncology Associates|
|Norfolk, Virginia, United States, 23502|
|Study Chair:||Noah Hahn, M.D.||Hoosier Cancer Research Network|