Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT00860158
Status:
TERMINATED
Last Update Posted:
2018-03-14
First Post:
2009-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer
Sponsor:
Noah Hahn, M.D.
Organization:
Study Overview
Official Title:
A Phase II Study of Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual; closed by funder
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: