New Clinical Trial: Early Switch From First-Line Docetaxel/Prednisone to Cabazitaxel/Prednisone in Metastatic Castration-Resistant Prostate Cancer

Dr. Tagawa
Dr. Tagawa

The Weill Cornell Urological Oncology Program has recently opened a new clinical trial for for men who have metastatic castration-resistant prostate cancer (mCRPC) and who have not previously been treated with chemotherapy for their cancer. The study is evaluating the benefit of an early switch from docetaxel plus prednisone  to cabazitaxel plus prednisone  if the PSA level is not reduced by at least 30% after 4 cycles of treatment. The opposite sequence will also be evaluated. The sponsor of the trial is Sanofi, and the principal investigator at Weill Cornell is Dr. Scott Tagawa.

For more information about the study, please call Renee Khan, RN at (212) 746-1851, e-mail Renee at rek9015@med.cornell.edu.

Key Eligibility
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Progressive disease while receiving hormonal therapy or after surgical castration
  • Have not received prior chemotherapy for prostate cancer
  • Detailed eligibility reviewed when you contact the study team\
Study Details

The purpose of this study is to evaluate the benefit of an early switch from docetaxel plus prednisone (Treatment A in this study) to cabazitaxel plus prednisone (Treatment B) if the PSA level is not reduced by at least 30% after 4 cycles of treatment. The opposite sequence will also be evaluated.

Cabazitaxel is FDA-approved for treating mCRPC previously treated with the chemotherapy drug docetaxel. However, cabazitaxel is not approved for treating mCRPC that has not been previously treated with chemotherapy, and therefore its use in this study is considered experimental.

Treatment Plan

Study participants will be randomly assigned to one of two treatment arms:

  • Treatment A: participants will receive docetaxel via infusion once every 3 weeks plus oral prednisone taken daily. Participants whose PSA level is not reduced by at least 30% after 4 treatment cycles will switch chemotherapy to receive cabazitaxel via infusion once every 3 weeks plus oral prednisone taken daily. Participants who do achieve a 30% or greater PSA reduction will continue taking docetaxel and prednisone.
  • Treatment B: participants will receive cabazitaxel via infusion once every 3 weeks plus oral prednisone taken daily. Participants whose PSA level is not reduced by at least 30% after 4 treatment cycles will switch chemotherapy to receive docetaxel infusion every 3 weeks plus daily oral prednisone. Those who do achieve a 30% or greater PSA reduction will continue taking cabazitaxel and prednisone.

Participants may continue to receive study treatment as long as they are responding to therapy and not experiencing intolerable side effects. As a key part of the research, investigational biomarkers (blood tests) will be explored to help researchers determine who will (or will not) benefit from each type of chemotherapy. After completing the treatment period, participants will be seen for follow-up every 3 months for the first year and then every 6 months for about 3.5 years.

Click here to view all current prostate cancer clinical trials in the Department of Medicine.