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

Inclusion Criteria

Histological or cytological proof of prostate cancer

Documented progressive mCRPC

Two or more bone lesions

Normal organ function with acceptable initial laboratory values within 14 days of randomization

Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.

Exclusion Criteria

Received any other investigational therapeutic agents or other anticancer therapies within 4 weeks prior to randomization.

Received external beam radiotherapy within the 4 weeks prior to randomization.

Has an immediate need for external beam radiotherapy.

Has received any systemic bone-seeking radiopharmaceutical in the past.

Has received any prostate cancer directed chemotherapy in the castration resistant setting. Subjects who have received up to 6 prior doses of docetaxel in the castration sensitive setting are permitted if they have not experienced disease progression within 36 weeks of last treatment with docetaxel.

Has received four or more systemic anticancer regimens for mCRPC.

Treatment with docetaxel or abiraterone for non-castrate metastatic disease is permissible and does not count towards the lines of therapy for mCRPC

Has received blood transfusions or growth factors within the last 4 weeks prior to randomization.

Symptomatic nodal disease (i.e., scrotal, penile, or leg edema).

Subjects with a "currently active" second malignancy other than non-melanoma skin cancers or non-invasive bladder cancers or other in-situ or non-invasive malignancies. Subjects are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.

Has imminent or established cord compression based on clinical findings and/or MRI.

Known bone marrow dysplasia

Has received any of the following in the 4 weeks prior to randomization: 5-alpha-reductase inhibitors, herbal medications, natural hormonally active foods (e.g., phytoestrogens) or other food supplements known to alter PSA in humans

Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including but not limited to:

- Uncontrolled infection

- NYHA III or IV heart failure

- Crohn's disease or those with ulcerative colitis who have not undergone a colectomy

- Known active infection with HIV, Hepatitis B or Hepatitis C