A Study to Test Radium-223 With Docetaxel in Patients With 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03574571|
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : September 18, 2020
|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.
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): NCT03574571
|Contact: Michael Morris, MDfirstname.lastname@example.org|
|Contact: Josef Fox, MD||212-639-7371|
|Principal Investigator:||Michael Morris, MD||Memorial Sloan Kettering Cancer Center|