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

Prostate Cancer Clinical Trial

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

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00860158
• Study type: Interventional
• Source: Hoosier Cancer Research Network
• Status: Terminated
• Phase: Phase 2
• Start date: March 2009
• Completion date: December 2010