This phase II trial studies how well cabazitaxel and prednisone work in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as cabazitaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
PRIMARY OBJECTIVES: I. To test whether men with a poor initial response to androgen deprivation therapy (ADT) have a better front line therapeutic response to cabazitaxel as compared to historical controls of frontline metastatic castrate resistant prostate cancer (CRPC) therapy with abiraterone or enzalutamide. SECONDARY OBJECTIVES: I. To determine the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 response rate, progression free survival (PFS) by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria, and overall survival (OS). II. To evaluate safety and toxicity profile of cabazitaxel in patients with CRPC. TERTIARY OBJECTIVES: I. To collect serum and tumor tissue samples for molecular markers or signature predictive of cabazitaxel benefit (to include status of androgen receptor \[AR\] pathway, androgen biosynthetic pathway genes, adenosine triphosphate \[ATP\]-binding cassette sub-family B member 1 \[ABCBI\], multidrug resistance-associated protein 1 \[MRP1\], and other mediators of taxane resistance). OUTLINE: Patients receive cabazitaxel intravenously (IV) over 1 hour on day 1 and prednisone orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Given IV
Given PO
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
PSA Response Rate, Defined as >= 50% Decline in PSA From Baseline Maintained for at Least 3 Weeks and Measured by the Same Laboratory, and Without Evidence of Other Disease Progression Documented at Time of Confirmatory Values
The response rate will be compared to a historical response rate of 20% using the exact binomial test for a single proportion. Confidence intervals for the response rate will be calculated using Wilson's method.
Time frame: Up to 18 months.
Incidence of Adverse Events, Serious Adverse Events, and Discontinuations, Described and Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03
Incidence of adverse events, serious adverse events, and discontinuations, described and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Time frame: Up to 28 days after discontinuation of study drug
Overall Survival (OS) Defined as the Time Interval From the Date of Enrollment to the Date of Death Due to Any Cause.
Confidence intervals for the response rate will be calculated using Wilson's method. Medians will be estimated using the method of Kaplan and Meier, with confidence intervals estimated using Greenwood's method.
Time frame: Up to 18 months.
Progression-free Survival (PFS) Defined as the Time Interval Between the Date of Enrollment and the Date of the First Documentation by the Prostate Cancer Working Group 2 (PCWG2) Criteria.
Confidence intervals for the response rate will be calculated using Wilson's method. Medians will be estimated using the method of Kaplan and Meier, with confidence intervals estimated using Greenwood's method.
Time frame: Approximately 5 months.
Response Evaluation Criteria in Solid Tumors (RECIST) Response Defined as Radiographic Disease Progression
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Confidence intervals for the response rate will be calculated using Wilson's method. Medians will be estimated using the method of Kaplan and Meier, with confidence intervals estimated using Greenwood's method.
Time frame: Approximately 5 months.