Castration-resistant prostate cancer (CRPC) with bone metastases
Conditions
Interventions
None listed
Sponsors
Department of Urology, Graduate School of Medical Sciences, Kyushu University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically confirmed prostate cancer. 2.The patients diagnosed as CRPC. 3.Patients undergoing continuous androgen removal by GnRH agonist and antagonist or bilateral orchiectomy. 4.Multiple bone metastases (>=2 hot spots) detected by bone scintigraphy within previous 12 weeks. 5.Age 20 years or older at the time of consent acquisition. 6.Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-2. 7.Expected survival is more than 6 months. 8.Preserved hematologic function within 4 weeks as follows; Absolute neutrophil count (ANC)>= 1500/mm3 Platelet count >=100,000/mm3 Hemoglobin >=10.0 g/dL 9.Patients who fully understand this research plan and can give their consent.
Exclusion criteria
Exclusion criteria: 1.Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bone metastases within previous 24 weeks. 2.Prior treatment with radium-223 3.Had history of gastrointestinal bleeding within 12 weeks. 4.Any active other malignancy. 5.History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations. 6.Patients with or confirmed a history of metastatic brain tumor. 7.Malignant lymphadenopathy exceeding 1.5 cm in short-axis diameter. 8. Imminent or established spinal cord compression based on clinical findings and/or MRI (Magnetic Resonance Imaging). 9.Any other serious illness or medical condition. 10.Substance abuse,medical,psychological, or social conditions that might interfere with the subject's participation in the study or evalution of the study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in amount of circulating tumor DNA (ctDNA) and in type and frequency of each gene abnormality by radium-223 treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Relationship between efficacy and prognosis of radium-223 treatment and amount of ctDNA, type and frequency and that changes of each gene abnormality. Identification of single nucleotide polymorphisms (SNPs) in genomic DNA that correlate with efficacy and prognosis of radium-223 treatment. Effectiveness and prognosis of radium-223 treatment. Radium-223 adverse events, bone effects. | — |
Countries
Japan
Contacts
Public ContactMasaki Shiota
Kyushu University Hospital Department of Urology
Outcome results
None listed