Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00924807|
Recruitment Status : Terminated (Sponsor closed the trial)
First Posted : June 19, 2009
Results First Posted : March 17, 2015
Last Update Posted : December 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Leuprolide acetate, Bicalutamide, Sorafenib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Sorafenib Concurrent With Androgen Deprivation and Radiotherapy in the Treatment of Intermediate- and High-Risk Localized Prostate Cancer|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Experimental: Androgen Depr, Radiotherapy, Sorafenib
Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.
Drug: Leuprolide acetate, Bicalutamide, Sorafenib
Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg
- Determine the Safety and Maximally Tolerated Dose of Sorafenib Administered Concurrently With Radiotherapy in the Treatment of Intermediate- and High-risk Localized Prostate Cancer. [ Time Frame: Day 29 and every 2 weeks ]Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.
- Biochemical Disease-free Survival [ Time Frame: after 9 months ]Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.
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): NCT00924807
|United States, New York|
|St.Luke's-Roosevelt Hospital Center|
|New York, New York, United States, 10019|
|Principal Investigator:||Seth Cohen, MD||St. Luke's-Roosevelt Hospital Center|