A Study to Test Radium-223 With Docetaxel in Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03574571|
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : June 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Docetaxel 75 mg/m2 Drug: Docetaxel 60 mg/m2 Drug: Radium-223||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||738 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is an open-labeled, randomized, phase III study of docetaxel versus docetaxel in combination with radium-223 in subjects with mCRPC.|
|Masking:||None (Open Label)|
|Official Title:||Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)|
|Actual Study Start Date :||June 19, 2018|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2023|
Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses. Prednisone will be given at a dose of 5mg orally twice daily.
Drug: Docetaxel 75 mg/m2
Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses.
Experimental: Docetaxel with Radium-223
Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses. Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.
Drug: Docetaxel 60 mg/m2
Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses.
Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.
- Overall survival [ Time Frame: 2 years ]Overall survival is defined as the time from randomization to death from any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574571
|Contact: Michael Morris, MDemail@example.com|
|Contact: Josef Fox, MD||212-639-7371|
Show 32 Study Locations
|Principal Investigator:||Michael Morris, MD||Memorial Sloan Kettering Cancer Center|