A Phase III Study of Stereotactic Body Radiation Therapy Alone and with Degarelix in Men with Intermediate-Risk Prostate Cancer

Full Title

Phase III Randomized Trial Comparing Short Course Androgen Deprivation Therapy and Ultra-Hypofractionated SBRT versus SBRT Alone For Intermediate Prostate Cancer


Prostate cancer is fueled by the male hormone testosterone. Degarelix is a drug used to treat prostate cancer by reducing testosterone production. It is typically given with external radiation therapy to men with prostate cancer that has an intermediate risk of progressing. Giving hormonal therapy with radiation therapy makes prostate cancer cells more sensitive to the radiation.

Conventional radiation therapy is given daily over several weeks. It is standard to give a six-month course of hormone therapy along with conventional radiation treatments. Stereotactic body radiation therapy (SBRT) is given at higher doses over fewer sessions (in this study, every other day for five days). It is unknown whether hormone therapy is necessary when giving SBRT to patients with intermediate-risk prostate cancer. The purpose of this study is to compare the effectiveness of SBRT alone to SBRT with degarelix in men with intermediate-risk prostate cancer. Patients will be randomly assigned to receive one treatment regimen or the other.


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

  • Patients must have intermediate-risk prostate cancer.
  • Except for prior prostate removal surgery or hormonal therapy 30 or more days before entering the study, patients may not have had previous treatment for prostate cancer (such as chemotherapy).
  • This study is for men age 18 and older.

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





Disease Status

Newly Diagnosed