Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04597125
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2020-10-16
Brief Title:
Investigation of Radium-223 Dichloride Xofigo a Treatment That Gives Off Radiation That Helps Kill Cancer Cells Compared to a Treatment That Inactivates Hormones New Antihormonal Therapy NAH in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official 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 onAfter One Line of NAH
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Researchers in this study want to compare how well drug radium-223 dichloride Xofigo and new novel anti-hormonal NAH therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone The NAH drugs used in this study will be either abiraterone acetate Zytiga plus prednisoneprednisolone or enzalutamide Xtandi Both of them are standard approved medications which are used in the treatment of advanced prostate cancer
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505830-89-00 | OTHER | None | None |
| 2019-000476-42 | EUDRACT_NUMBER | CTIS EU | None |