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 prednisone/prednisolone) 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
654
Participants will receive Radium-223 (BAY88-8223) every 4 weeks for a total of 6 administrations via intravenous (IV) injection
Participants will receive continuous NAH (either Abiraterone acetate plus prednisone/prednisolone \[AAP\] or enzalutamide) by mouth (per os) daily
Specialist Services Medical Group
Castle Hill, New South Wales, Australia
Gosford Hospital
Gosford, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
North West Cancer Centre
North Tamworth, New South Wales, Australia
Northern Cancer Institute
St Leonards, New South Wales, Australia
Overall survival (OS)
Time frame: Up to five years
Time to first symptomatic skeletal event (SSE)
Time frame: Up to five years
Radiological Progression-free survival (rPFS)
rPFS is defined as the time from the date of randomization to the date of confirmed radiological progression or death, whichever occurs first.
Time frame: Up to five years
Time to pain progression (BPI-SF)
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.
Time frame: Up to five years
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
Incidence of fractures
Time frame: Up to five years
Time to deterioration of FACT-P total score
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.
Time frame: Up to five years
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Prince of Wales Hospital NSW
Sydney, New South Wales, Australia
Illawarra Shoalhaven Local Health District
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