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EXCAAPE
OFFICIAL TITLE: A PHASE II CLINICAL TRIAL OF RADIUM-223 ACTIVITY IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) WITH ASYMPTOMATIC PROGRESSION WHILE ON ABIRATERONE ACETATE OR ENZALUTAMIDE BESIDES AR-V7 MUTATIONAL STATUS.
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RADIUM-223 IS INDICATED FOR THE TREATMENT OF PATIENTS WITH MCRPC WITH SYMPTOMATIC BONE METASTASES AND NO KNOWN VISCERAL METASTATIC DISEASE. HOWEVER, VERY FEW DATA HAVE BEEN REPORTED IN PATIENTS WITH MCRPC WHO ARE ASYMPTOMATIC OR MILDLY SYMPTOMATIC. RECENTLY, RESULTS FROM AN INTERNATIONAL EXPANDED ACCESS PROGRAM HAVE ALSO SUGGESTED A BENEFIT OF RADIUM-223 IN ASYMPTOMATIC PATIENTS WITH MCRPC. IN ADDITION, THE MECHANISM OF ACTION OF RADIUM-223 SHOULD NOT BE CORRELATED WITH THE PRESENCE/ABSENCE OF THE AR-V7 MUTATION, ALTHOUGH THIS ISSUE HAS NOT YET BEEN EVALUATED.
THE AIM OF THIS STUDY IS TO ASSESS THE EFFICACY OF RADIUM-223 IN ASYMPTOMATIC PATIENTS WITH MCRPC, AND TO ESTABLISH THE ASSOCIATION BETWEEN AR-V7 STATUS AND RADIUM-223 ACTIVITY.
EXCAAPE AT CLINICALTRIALS.GOV
TUMOR TYPE
PHASE
N
SITES
COUNTRY
STATUS
mCRPC
II
52
9
Spain
Closed
SPAIN
Hospital Universitario Vall d'Hebron
SPAIN
Hospital Clínic de Barcelona
SPAIN
Hospital Universitario Ramón y Cajal
SPAIN
Hospital Reina Sofía
SPAIN
Hospital San Pedro Alcántara
SPAIN
Hospital Parc Taulí
SPAIN
Instituto Catalán de Oncología de Hospitalet (ICO)
SPAIN
Hospital Lucus Augusti
SPAIN
Hospital Universitari Son Espases
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