NCT00860158

Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer

A Phase II Study of Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Noah Hahn, M.D. · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will investigate the activity of dasatinib plus LHRH analogue therapy in high-risk localized prostate cancer.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Dasatinib	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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2009-03-12
• Last updated: 2018-03-14
• Results posted: 2016-02-05

Locations

6 sites across 1 country: United States