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
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1. Overall survival (OS) (Time Frame - Up to five years)
Secondary outcome:
1. Time to first symptomatic skeletal event (SSE) (Time Frame - Up to five years)
2. Radiological Progression-free survival (rPFS) (Time Frame - Up to five years): rPFS is defined as the time from the date of randomization to the date of confirmed radiological progression or death, whichever occurs first.
3. Time to pain progression (BPI-SF) (Time Frame - Up to five years): The Brief Pain Inventory-Short Form (BPI-SF) is a self-administered questionnaire with 11 items designed to evaluate the intensity of, and the impairment caused by pain. Four items measure pain intensity using 0 ("no pain") to 10 ("pain as bad as you can imagine") numeric rating scales, and 7 items measure the level of interference with function caused by pain using 0 (no interference) to 10 (complete interference) rating scales.
4. Adverse events assessments using NCI CTCAE (v5.0) (Time Frame - After first administration of study intervention up to 30 days after the last dose of study intervention)
5. Incidence of fractures (Time Frame - Up to five years)
6. Time to deterioration of FACT-P total score (Time Frame - Up to five years): The FACT-P questionnaire assesses prostate cancer-related quality of life. The FACT-P total score is the sum of the scores of 39 items of the questionnaire and ranges from 1 to 156, the higher the score, the better the quality of life of prostate cancer patients.
Experimental: Arm A Participants with bone dominant metastatic castration resistant prostate cancer (mCRPC) progressing on/after one line of NAH will be randomized to receive radium-223 dichloride
Active Comparator: Arm B Participants with bone dominant metastatic castration resistant prostate cancer (mCRPC) progressing on/after one line of NAH will be randomized to receive second novel anti-hormonal therapy (NAH)
Radium-223 dichloride (Xofigo, BAY88-8223): Participants will receive Radium-223 (BAY88-8223) every 4 weeks for a total of 6 administrations via intravenous (IV) injection
NAH therapy (Second novel anti-hormonal therapy): Participants will receive continuous NAH (either Abiraterone acetate plus prednisone/prednisolone [AAP] or enzalutamide) by mouth (per os) daily
Quelle: ClinicalTrials.gov
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"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"
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