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Clinical Trial 19367
Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT03511196
Phase: Early Phase I
Prinicipal Investigator: Jingsong Zhang
Study Title
A Phase 1b Study of Adaptive Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer
Summary
The purpose of this study is to develop adaptive therapy for high risk metastatic castration sensitive prostate cancer (mCSPC).
Objective
Exploratory objectives/correlative studies: Detect the intra-tumor heterogeneity of AR and Cyp17 IHC stains on FFPE blocks of primary prostate cancer and or metastatic lesions. Refine the mathematical model for adaptive ADT. To develop imaging habitat biomarkers to track diseases progression using the patients scans and compare with conventional progression variables (like PSA). Compare the AR, Cyp17 IHC stains as well as imaging biomarkers with a retrospective cohort of mCSPC patients who underwent continuous ADT as standard of care.
Therapies
Medications
ADT (); Abiraterone acetate (); Apalutamide (); Bicalutamide (); Casodex (Bicalutamide); Enzalutamide (Xtandi); Zytiga (Abiraterone acetate); prednisone ()
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