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DORA Trial: Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Recruiting

The purpose of this research is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy (at a lower dose) treatment versus using docetaxel alone (at the usual dose). The addition of radium-223 to docetaxel could be a better cancer treatment than just docetaxel alone, but it could also cause additional side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.

I'm interested

Male
18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• diagnosis of prostate cancer
• confirmed progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
• two or more bone lesions
• serum testosterone less than 50 ng/dL
• able to walk, carry out light work, and care for self independently
Exclusion Criteria:

• received four or more systemic anticancer regimens for mCRPC (study staff will review) -received any prostate cancer chemotherapy for mCRPC
• any other serious illness or medical condition

Drug: Docetaxel 60 mg/m2, Drug: Docetaxel 75 mg/m2, Drug: Radium-223

Cancer

Clinics and Surgery Center (CSC), Metastatic Castration-Resistant Prostate Cancer (mCRPC), Prostate Cancer, Prostate Cancer

Gautam Jha - jhaxx014@umn.edu
Gautam Jha
Phase 3
SITE00001099
See this study on ClinicalTrials.gov

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