TAXYNERGY: Early Switch From First-Line Docetaxel/Prednisone to Cabazitaxel/Prednisone and the Opposite Sequence, Exploring Molecular Markers in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study Status

Open to Enrollment

Study Description

This clinical trial is for men who have metastatic castration-resistant prostate cancer (mCRPC) and who have not previously been treated with chemotherapy for their cancer.

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.

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.

Sponsor

Sanofi

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

Principal Investigator

Scott Tagawa, MD

Contact

Healthy Volunteers

healthy_volunteers.jpg

As a healthy volunteer in a clinical trial you may make a significant contribution to the discovery of medical knowledge and new treatments that could impact people around the world.
Click here for studies seeking healthy volunteers.

Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

Top of page