A Randomized, Open Label, Multicenter Study of Cabazitaxel Versus an Androgen Receptor (AR)-Targeted Agent (Abiraterone or Enzalutamide) in mCRPC Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent (CARD)
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https://search.vivli.org/doiLanding/studies/PR00008388/isLanding
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Primary Objective:
To compare the radiographic progression-free survival (rPFS) (using Response Evaluation
Criteria in Solid Tumors [RECIST] 1.1 for tumor lesions and Prostate Cancer Working Group 2
(PCWG2) criteria for bone scan lesions or death due to any cause) with chemotherapy
(cabazitaxel plus prednisone, Arm A) versus Androgen Receptor (AR)-targeted therapy
(enzalutamide or abiraterone acetate plus prednisone, Arm B) in mCRPC participants who have
been treated with docetaxel and who had disease progression while receiving AR-targeted
therapy within 12 months of AR treatment initiation (less than or equal to [<=]12 months,
either before or after docetaxel).
Secondary Objective:
- To compare efficacy for:
- Prostate-specific antigen (PSA) response rate and time to PSA progression (TTPP).
- Progression-free survival (PFS).
- Overall survival (OS).
- Tumor response rate and duration of tumor response.
- Pain response and time to pain progression.
- Symptomatic skeletal event (SSE) rate and time to occurrence of any SSE.
- Health status and Health-related Quality of Life (HRQOL).
- To evaluate the correlation of a signature of resistance to AR-targeted agents with
clinical outcome via the analysis of circulating tumor cell (CTC) phenotypes as well as
expression and localization of proteins including AR isoforms in CTCs.
- To evaluate safety in the 2 treatment arms.
提供机构:
Vivli
创建时间:
2022-08-24



