A Phase I Study of Dasatinib, Androgen Deprivation Therapy and Radiation For Intermediate and High Risk Prostate Cancer
Radiation and androgen deprivation is a common modality for patients with localized prostate
cancer. Unfortunately for patients with intermediate to high risk prostate cancer incomplete
tumor eradication and subsequent relapse occurs in 50-75% of patients. The Src pathway
appears to be integral to the pathobiology of prostate cancer and may be fundamental to
radioresistance.
The primary objective of this trial will be to establish the safety of dasatinib with
androgen deprivation and radiation for prostate cancer. Three dasatinib dose levels will be
evaluated, 50 mg/day, 70 mg/day and 100 mg/day. Dasatinib will begin with day #1 of
radiation and will be discontinued once radiation is completed. The study treatment period,
therefore, will be when patients receive concurrent dasatinib, hormone therapy and radiation
to 30 days after the last radiation/dasatinib treatment. However, it will be highly
recommended that, prior to entering the study, patients receive 2 months of androgen
deprivation with a LHRH agonist. Furthermore, it will be highly recommended that, after
completion of dasatinib /hormone therapy/radiation, patients with intermediate risk disease
receive approximately 2 additional months of hormone therapy (to complete 6 months of
hormone therapy) and patients with high risk disease receive 20 additional months of ADT to
complete 2 years of hormone therapy. If casodex was given at onset of diagnosis, patient
must be off drug for 6 weeks prior to beginning radiation therapy
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of dasatinib with concurrent standard radiation and hormone therapy
3 months
Yes
anthony mega
Principal Investigator
Brown University Oncology Research Group
United States: Food and Drug Administration
BrUOG 255
NCT01826838
January 2013
January 2014
Name | Location |
---|---|
Rhode Island Hospital | Providence, Rhode Island 02903 |
Miriam Hospital | Providence, Rhode Island 02906 |