Bone Metastatic Prostate Cancer Clinical Trial
Official title:
A Study of Cabazitaxel Treatment in Castration Resistant Bone Metastatic Prostate Cancer Patients Evaluating the Tumor Microenvironment
This is a prospective, open-label, single arm translational study of cabazitaxel in bone Castration Resistant metastatic Pancreatic Cancer (mCRPC) patients. Patient will be treated with intravenous (iv) cabazitaxel 25mg/m2 every (q) 21days per standard clinical practice for up to 10 cycles or until disease progression or unacceptable toxicity or physician's decision or patient's consent withdrawal (whichever occurs first).
This is an open-label, interventional study to explore the effect of Cabazitaxel on survival
pathways and androgen signaling in the tumor microenvironment (bone marrow) of patients with
castration resistant metastatic prostate cancer.
A total of 30 evaluable patients are needed. An estimated 50% chance of failure to harvest
evaluable bone marrow biopsy or aspirate is anticipated based on investigators prior
experience. Thus a total of 60 patients will be accrued in the study. This will provide the
investigators an 80% power to detect an effect size of at least 0.82, using a two-sided
paired t-test and at a 0.05 significance level.The changes in androgen signaling (androgen
receptor expression and other survival pathway markers, between baseline and 9 weeks will be
assessed by paired t-test and Wilcoxon signed-rank test. The association between serum
Prostate-Specific Androgen (PSA) and bone marrow androgen signaling level will be evaluated
using scatter plot and spearman's correlation coefficient. Similar methods will be used to
explore the association between circulating androgens and those in the bone marrow.
Biomarker data will also be summarized and compared between baseline and after treatment
using paired t-test or Wilcoxon signed-rank test.
ECOG changes from baseline will be provided for each treatment period. All Adverse Events
(AE) will be graded using the National Cancer Institute - Common Terminology Criteria for
Adverse Events (NCI-CTCAE) classification, version 4.3.
Summary tables of Adverse Events (AE)s, Treatment Emergent Adverse Event(TEAE), Serious
Adverse Events (SAE)s and withdrawals for adverse events will be provided by treatment
period. Adverse events will be summarized by worst severity grade AEs.
All registered subjects who take at least 1 dose of agent will be included in the safety
analyses. Adverse events will be summarized by worst severity grade. AEs, as well as
treatment-emergent AEs, will be summarized by system organ class, and preferred term.
Investigational Medicinal Products (IMP) -related adverse events, adverse events leading to
death or to discontinuation from treatment, events classified as NCI-CTCAE v4 Grade 3 or
Grade 4 (or moderate/severe if other rating scale is used), (IMP)-related events, and serious
adverse events will be summarized separately.
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