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.

PROJECT DETAILS

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

Recruitment  closed

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EXCAAPE SITES

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