Study on Enzalutamide With or Without Radium Ra 223 Dichloride for Treating Metastatic, Castration-Resistant Prostate Cancer
Sponsor: University of Southern California
ClinicalTrials ID:NCT03344211
This clinical trial is testing whether the drug enzalutamide, alone or combined with radium Ra 223 dichloride, can effectively treat prostate cancer that has spread and is resistant to hormone therapy. The study aims to see if this combination can better control the cancer and improve patient outcomes.
Patient Parameters
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Program Overview
This study is exploring how well enzalutamide, with or without radium Ra 223 dichloride, works in treating prostate cancer that has spread to other parts of the body and is resistant to hormone therapy. Enzalutamide blocks male hormones that help prostate cancer grow, while radium Ra 223 uses radiation to target and kill cancer cells. The study will compare the effectiveness of enzalutamide alone versus in combination with radium Ra 223.
Description
The main goals of this study are to see how enzalutamide, alone or with radium Ra 223, affects prostate cancer in the bones, including changes in cancer spread, hormone levels, and immune response. Researchers will also look at the safety of the treatment and any side effects. Patients will be randomly assigned to one of two groups: one group will receive enzalutamide and radium Ra 223, while the other group will receive only enzalutamide. Both treatments will be given in cycles every 28 days, and patients will be monitored for any disease progression or side effects. After completing the treatment, patients will have follow-up visits every three months for a year and a half.
Eligibility Criteria
Inclusion Criteria
- Men with prostate cancer that has spread to the bones and is resistant to hormone therapy.
- Cancer must show signs of progression, such as rising PSA levels, new metastases, or increased symptoms despite ongoing hormone therapy.
- Must have bone metastases, but other metastases are allowed.
- No prior chemotherapy with docetaxel or cabazitaxel for this type of cancer, but prior abiraterone is allowed.
- Good overall health with an ECOG performance status of 0 or 1.
- Adequate blood counts and organ function, including hemoglobin, neutrophil, and platelet levels.
- Ability to understand and sign informed consent.
Exclusion Criteria
- Previous treatment with docetaxel or cabazitaxel for this type of cancer.
- Previous treatment with enzalutamide or similar drugs, unless recently started with less than 15 days of use.
- Use of other hormone therapies or immunosuppressive drugs, with some exceptions.
- Previous treatment with certain radioactive drugs for bone metastases.
- History of seizures or recent stroke.
- Untreated brain metastases or certain severe illnesses.
- Chronic diarrhea or inflammatory bowel disease.
- Known hepatitis B or C, or liver cirrhosis.
- Severe uncontrolled illnesses that would interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope | 91010 | Duarte | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Cedars Sinai Medical Center | 90048 | Los Angeles | California |
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