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
Patient Education
Patient Education Not Yet Provided
Publications
Publications Not Yet Provided
Locations
Australia
Austria
Czech Republic
Finland
France
Germany
Hong Kong
Hungary
Israel
Italy
Lithuania
Poland
Russia
South Korea
Spain
Taiwan
Türkiye
United Kingdom