A Phase II Study of Stereotactic Body Radiation Therapy and Radium Dichloride to Treat Prostate Cancer that Has Spread to the Bones

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Full Title

SAXON-PC: A Phase II Randomized Trial of Stereotactic Body Radiation Therapy (SBRT) And Radium (Ra-223) Dichloride for Oligorecurrent, Non-castrate Resistant Prostate Cancer

Purpose

Men whose prostate cancer spreads to the bones after receiving initial treatment with surgery and/or radiation therapy may be offered treatment with stereotactic body radiation therapy (SBRT), especially when disease spread is limited to a few areas. They may then need hormonal therapy.

In this study, researchers want to see if combining radium-223 dichloride with SBRT may prevent the cancer from continuing to spread and delay the need for hormonal therapy. Radium-223 dichloride targets bone tissue that is changing (as it does when cancer spreads to the bone) and gives off radiation that can kill prostate cancer cells in the bone.

Participants in this study will be randomly assigned to receive SBRT alone or with radium-223 dichloride. Radium-223 dichloride is given as an injection.

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have prostate cancer that spread to the bone after initial surgery and/or radiation therapy.
  • Patients must have prostate cancer spread that is limited to one to three sites in the bones.
  • At least 4 weeks must pass since finishing prior treatments and receiving the study therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for men age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Michael Zelefsky at 212-639-6802.

Protocol

21-213

Phase

II

Investigator