Prostate Adenocarcinoma Clinical Trial
Official title:
Identifying Mechanisms of Resistance to Enzalutamide (MDV3100) Treatment in Men With Castration-Resistant Prostate Cancer
This research trial studies molecular features and pathways in predicting drug resistance in patients with castration-resistant prostate cancer that has spread to other parts of the body and who are receiving enzalutamide. Studying samples of blood and tissue in the laboratory from patients receiving enzalutamide may help doctors learn more about molecular features and pathways that may cause prostate cancer to be resistant to the drug.
PRIMARY OBJECTIVES:
I. To assess the correlations between baseline molecular features and pathways and
prostate-specific antigen (PSA) response (</>= 50% decline) at 12 weeks versus (vs.)
baseline.
SECONDARY OBJECTIVES:
I. To assess the correlations between the baseline molecular features and pathways and
progression-free survival (defined as time from day 1 of study drug treatment to date of
radiographic progression or clinical progression), disease-specific survival (defined as the
time from day 1 of study drug to date of death from prostate cancer), and overall survival
(defined as time from day 1 of study drug treatment to date of death from any cause).
II. To assess the correlations between the baseline molecular features and pathways and time
to PSA progression.
III. To identify molecular features and cellular pathways present in tumors from men with
metastatic castrate-resistant prostate cancer (CRPC) that are progressing despite
enzalutamide treatment.
IV. To explore correlation between baseline molecular features and pathways and objective
response.
V. To assess the correlations between the baseline molecular features and pathways and degree
of PSA decline at 12 weeks and maximal PSA decline observed while on study.
VI. To assess the correlations between the baseline molecular features and time on treatment.
TERTIARY OBJECTIVES:
I. To assess correlations between cell-free deoxyribonucleic acid (cfDNA) molecular features
from blood and molecular features and pathways from the biopsy samples.
II. To assess correlations between cfDNA molecular features and endpoints in the primary and
secondary objectives listed above.
III. To explore correlations with baseline molecular features and tissue histology.
IV. To explore correlations with baseline tissue histology and PSA change, time to PSA
progression, time on treatment, progression-free survival, and overall survival.
OUTLINE:
Patients undergo collection of blood and tissue samples at baseline, during administration of
enzalutamide, and after the time of disease progression for analysis via
immunohistochemistry, comparative genome hybridization, and sequencing.
After completion of study, patients are followed up every 12 weeks.
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