Study Title
A Phase 4, Randomized, Open-label, Multicenter Efficacy and Safety Study of Standard Dose of Radium-223 Dichloride vs. Standard Doses of Novel Anti-hormonal Therapy (NAH) in Patients With Bone Dominant Metastatic Castration Resistant Prostate Cancer (mCRPC) Progressing on/After One Line of NAH
Study Details
Description:
Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain.
Sponsor:
BayerContacts:
Bayer Clinical Trials Contactclinical-trials-contact@bayer.com
(+)1-888-84 22937
Government Study Link:
NCT04597125 - Click here to see study onClinicalTrials.gov
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Publications
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Locations
Australia
Austria
Czech Republic
Finland
France
Germany
Hong Kong
Hungary
Israel
Italy
Lithuania
Poland
Russia
South Korea
Spain
Taiwan
Türkiye
United Kingdom
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