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A study, in patients with prostate cancer that has spread to the bones, investigating the efficacy of radium-223 dichloride given as a 50kBq/kg dose every four weeks or a 80kBq/kg dose every four week...

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-003118-42

A study, in patients with prostate cancer that has spread to the bones, investigating the efficacy of radium-223 dichloride given as a 50kBq/kg dose every four weeks or a 80kBq/kg dose every four weeks in radium-223 dichloride naive patients for six doses or as a 50kBq/kg every four weeks to patients who have already been treated with a course of six doses of radium-223 dichloride

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Extrait

• To evaluate efficacy as measured by symptomatic skeletal event-free survival (SSE-FS) of radium-223 dichloride 50 kBq/kg every 28 days for up to 6 doses compared to radium-223 dichloride 80 kBq/kg every 28 days for up to 6 doses in subjects with CRPC metastatic to the bone not previously receiving radium-223 dichloride • To evaluate efficacy as measured by SSE-FS of radium-223 dichloride 50 kBq/kg every 28 days for up to 6 additional doses compared to no further radium-223 dichloride treatment in subjects with CRPC metastatic to the bone who previously received radium-223 dichloride 50 kBq/kg every 28 days for up to 6 doses, and survived SSE-free and are eligible for further radium-223 dichloride treatment.

Critère d'inclusion

  • Castration resistant prostate cancer with bone metastasis

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