This study is to evaluate preliminary efficacy of Ra-223 in combination with Enzalutamide in progressive CRPC patients with bone metastasis
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Ra-223 (55 kBq/kg i.v.) 6 injections at 4 weeks interval in combination with enzalutamide 160 mg per a day
Osaka City University Graduate School of Medicine
Osaka, Japan
Changes in Alkaline phosphatase (ALP)
Percentage of change from baseline to 6 months (or earlier for those who discontinue study therapy)
Time frame: 6 months
Tolerability of Radium-223 therapy
Proportion of patients who complete 6 times injections of radium-223
Time frame: 6 months
Evaluation for bone metastasis by 18F-NaF-PET
Fractional decline of intensity of tracer uptake measured by SUVmax on 18F-NaF-PET at 1, 3, 6 months.
Time frame: 1, 3, 6 months
Evaluation for bone metastasis by bone scintigraphy
The change of Bone Scan Index (BSI) by bone scintigraphy at 1, 3, 6 months.
Time frame: 1, 3, 6 months
Overall Survival Rate
Overall Survival (OS) is defined as the time from the registration to death due to any cause, or censored at date last known alive.
Time frame: 3 years
Time to occurrence of Symptomatic Skeletal-related Events (SSEs)
Time to occurrence of SSEs are defined asthe time from registration to the date of the occurrence of SSEs (symptomatic fracture, surgery or radiation to bone, or spinal cord compression).
Time frame: 1 year
Time to occurrence of visceral metastasis
Time to occurrence of visceral metastasis was defined as the time from registration to the date of the occurrence of a visceral metastasis for each patient.
Time frame: 1 year
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Time to initiation of cytotoxic chemotherapy
The time to initiation of cytotoxic chemotherapy is defined as the time from registration to the date of initiation of cytotoxic chemotherapy.
Time frame: 1 year
Changes in Prostate Specific Antigen (PSA)
Percent change in prostate-specific antigen (PSA) from baseline at 6 months.
Time frame: 6 months
Changes From Baseline for Brief Pain Inventory (BPI)
The change for the BPI-SF (Brief Pain Inventory-Short Form) score was calculated.
Time frame: 6 months
Changes From Baseline for Functional Assessment of Cancer Therapy - Prostate (FACT-P)
The change for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated.
Time frame: 6 months
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Number of participants with adverse events as a measure of safety and tolerability.
Time frame: 6 months