This phase II trial studies how well orteronel works in treating patients with metastatic hormone-resistant prostate cancer. Orteronel may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To assess the relationship between circulating tumor cell (CTC)-based androgen receptor (AR) expression level and \>=-50% prostate-specific antigen (PSA) decline following 12 weeks of therapy with TAK-700 (orteronel). SECONDARY OBJECTIVES: I. To assess changes in PSA and CTC levels and time to PSA progression (best response, decline at 12 weeks as continuous variable, etc.) with or without prior docetaxel-based treatment. II. To assess measurable disease response and time to radiographic disease progression for castration-resistant prostate cancer (CRPC) with or without prior docetaxel-based treatment. III. To explore relationships between endocrine and clinical responses. IV. To confirm the safety of TAK-700 administered without prednisone in patients with metastatic CRPC. OUTLINE: Patients receive orteronel orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Given PO
Correlative studies
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Androgen Receptor (AR) Protein Expression Levels in CTCs
The two-sample t-test will be used. Once association between AR protein expression levels and response is established, graphical methods such as receiver-operator curves (ROC) or more quantitative methods such as the maximal chi-square method to determine whether there might be a cut-point with either great sensitivity or great specificity (or both) for identifying a cohort with either a high or low likelihood of prostate-specific antigen (PSA) response.
Time frame: Up to 4 weeks
PSA Response, Defined as Occurrence of PSA Decline to Greater Than or Equal to 50% From Baseline
Standard descriptive methods will be used to summarize PSA. Values will be tabulated as outlined in the Prostate Cancer Working Group 2 (PCWG2) criteria and presented as Kaplan-Meier survival curves, as appropriate.
Time frame: At 12 weeks
Best PSA Response
Values will be tabulated as outlined in the PCWG2 criteria and presented as Kaplan-Meier survival curves, as appropriate.
Time frame: Up to 24 weeks
Absolute Change in PSA
Values will be tabulated as outlined in the PCWG2 criteria and presented as Kaplan-Meier survival curves, as appropriate.
Time frame: Baseline to 24 weeks
Overall Response Rate Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and PCWG2 Criteria
Response will be tabulated descriptively with 95% confidence intervals (CIs) and Kaplan-Meier survival curves, as appropriate.
Time frame: Up to 3 years
Duration of Response Using RECIST Version 1.1 and PCWG2 Criteria
Response will be tabulated descriptively with 95% CIs and Kaplan-Meier survival curves, as appropriate.
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Time frame: Up to 3 years
Number of Participants With Grade 3 or Higher Toxicity
Summary of grade 3 (per Common Terminology Criteria for Adverse Events (CTCAE v4.0) or higher toxicities which generally is described as a severe reaction or symptom.
Time frame: 30 days