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About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Histologically confirmed prostate adenocarcinoma
Metastatic disease
Able and willing to provide informed consent and to comply with the study procedures
Castration resistant disease defined as evidence of radiological and/or prostate specific antigen (PSA) progression despite castrate levels of testosterone (serum testosterone < 50 ng/dL [1.7 nmol/L]); for PSA progression, there must be at least 2 sequential rises at a minimum of 1-week intervals; the first PSA value must be >= 4 (Prostate Cancer Working Group 2 [PCWG2] criteria)
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
At least 21 days have passed since completing radiotherapy (exception for radiotherapy: at least 7 days since completing a single fraction of =< 800 cGy to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of registration
At least 21 days have passed since receiving any investigational agent at the time of registration
At least 21 days have passed since major surgery
Neuropathy =< grade 1 at the time of registration
Has recovered from all therapy-related toxicity to =< grade 2 (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy) at the time of registration
Poor prognosis disease as defined by any of the following:
Hemoglobin >= 90 g/L
Neutrophils >= 1.5 x 10^9 /L
Platelets >= 100 x 10^9/L
Aspartate aminotransferase (AST) < 1.5 x upper limit of normal (ULN)
Alanine aminotransferase (ALT) < 1.5 x ULN
Bilirubin =< 1.0 x ULN (exceptions for Gilbert's syndrome)
Creatinine =< 1.5 x ULN
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
2 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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