CRPC patients with bone metastasis
Conditions
Interventions
None listed
Sponsors
Nippon Medical School
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Symptomatic metastatic castration resistant prostate cancer with bone metastasis with no known visceral metastasis (1)Histologically or cytologically confirmed prostate cancer with medical or surgical castration, and who to be treated with Ra-223 (2)With bone metastases (≥ 2 hot spots) on bone scintigraphy prior to enrollment (3)Age ≥ 20 (4)Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-2 (5)Life expectancy ≥ 6 months (6)Laboratory requirements: -Absolute neutrophil count (ANC) ≥ 1.5 x 109/L -Platelet count ≥ 100 x 109/L -Hemoglobin ≥ 10.0 g/dL -Total bilirubin level ≤ 1.5 institutional upper limit of normal (ULN) -Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 ULN -Creatinine ≤ 1.5 ULN, and estimated glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2
Exclusion criteria
Exclusion criteria: (1)Prior treatment within 1 week before enrollment or any combination use during the study with abiraterone and prednisone/prednisolone, enzalutamide, or chemotherapies (2)Prior hemibody external radiation (3)Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bone metastases within previous 24 weeks (4)Had history of gastrointestinal bleeding or ulcer within 3 months prior to study entry (5)Other malignancy treated prior to enrollment (except non-melanoma skin cancer or low-grade superficial bladder cancer) (6)History of visceral metastasis, or visceral metastases as assessed by screening imaging examination (7)Known brain metastasis (8)Malignant lymphadenopathy exceeding 3 cm in short-axis diameter (9)Imminent or established spinal cord compression based on clinical findings and/or MRI (Magnetic Resonance Imaging) (10)Any other serious illness or medical condition (11)Substance abuse, medical, psychological, or social conditions that might interfere with the subject's participation in the study or evaluation of the study (12)Those who have any contraindication to MRI or other Magnetic Imaging
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To preliminarily compare multiple modalities (SPECT-CT, FDG-PET and MRI) in terms of predicting overall survival after Ra-223 treatment in CRPC patients with bone metastasis | — |
Secondary
| Measure | Time frame |
|---|---|
| To preliminarily compare multiple modalities in terms of predictability of SSE-FS | — |
Countries
Japan
Contacts
Public ContactTomohiro Tsukagoshi
Nippon Medical School Hospital Department of Radiology
Outcome results
None listed