A Phase I/IIa Study of Alpharadin® Plus Docetaxel in Patients with Bone Metastases from Castration-Resistant Prostate Cancer

Protocol
10-086
Full Title
A Phase I/IIa Study of Safety and Efficacy Of Alpharadin® With Docetaxel In Patients With Bone Metastases From Castration-Resistant Prostate Cancer
Phase
I/II
Purpose

Docetaxel is a chemotherapy drug commonly used in men with advanced prostate cancer that continues to grow and spread despite hormonal therapies (“castration-resistant” prostate cancer). The purpose of this study is to establish the optimal dose of and evaluate the effectiveness of a drug called Alpharadin when given in combination with docetaxel in men with bone metastases from castration-resistant prostate cancer.

Alpharadin is radium-223 chloride, a liquid that contains a radioactive element that specifically targets prostate cancer that has spread (metastasized) to bone. The radiation that radium-223 gives out travels only a very short distance in the body, and therefore acts mainly on the areas of the bones that require treatment: bone metastases.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have two or more bone metastases from castration-resistant prostate cancer.
  • Patients’ PSA levels must be 2 ng/mL or more, and testosterone levels must be 50 ng/dL or less.
  • At least 4 weeks must have passed since completion of prior therapy and entry into the study.
  • Patients must be age 18 or older

For more information about this study and to inquire about eligibility, please contact Dr. Michael Morris at 646-422-4469.

Disease(s)
Prostate Cancer
Prostate Cancer: Metastatic Disease after Hormone-Reducing Therapy
Locations
Related Diseases