Efficacy and Safety of Ra-223 as 1st line therapy in combination with alternative anti-androgen therapy for bone metastatic CRPC Patients

Sakamoto Shinichi0 个研究点目标入组 4 人开始时间: 2019年3月28日最近更新: 2023年10月17日

试验速览

This trial was terminated due to poor recruitment.

•1. Patients who are over 20 years of age at consent acquisition
•2. Histologically or cytologically confirmed prostate cancer
•3. Patients diagnosed asymptomatic or symptomatic CRPC with bone predominant metastatic and with no visceral metastasis (lymph node (<= 3cm) metastasis is allowed)
•4. Confirmed PSA progression with bicalutamide as 1st anti-androgen agent under Combined Androgen Blockade (CAB). Being received or planned to receive flutamide as alternative anti-androgen therapy.
•5. Multiple skeletal metastases (>= 2 hot spots) on bone scintigraphy within previous 12 weeks
•6. No experience of treatment with neither Abiraterone, Enzalutamide, Apalutamide (ARN-509), Docetaxel, Cabazitaxel, nor Darolutamide (ODM-201)
•7. Life expectancy >= 6 months
•8. ECOG Performance status : 0 or 1
•9. Adequate hematologic, renal, and liver function
•Absolute neutrophil count >= 1.5 x 109/L
•Platelet count >= 100 x 109/L
•Hemoglobin >= 10.0 g/dL
•Total bilirubin, AST, ALT, and creatine <= 1.5 x institutional upper limit of normal (ULN)
•10. Fully informed about the study; willing and able to comply with the protocol; must be signed the informed consent form

•1. Treatment history of cytotoxic chemotherapy (including Estramustine
•2. Prior hemibody external radiation therapy
•3. Systemic radiation therapy with radioisotopes (storontium-89, samarium-153, rhenium-186, or rhenium-188) within previous 24 weeks
•4. Prior treatment of Ra-223
•5. Blood transfusion or erythropoietin-stimulating agents within the previous 4 weeks
•6. Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
•7. History or presence of visceral metastases or brain metastases
•8. Malignant lymphadenopathy exceeding 3 cm in short-axis diameter
•9. Imminent or established spinal cord compression. Patients with history of spinal cord compression must have completely recovered
•10. Presence of liver disorders
•11. Any other serious illness or medical condition such as, but not limited to; any uncontrolled infection; cardiac failure NYHA III or IV; Crohn's disease or Ulcerative colitis; Bone marrow dysplasia
•12.Unmanageable faecal incontinence
•13. Patients who are inappropriate for the participation into this study due to any other reasons judged by each institutional physician

发起方

Sakamoto Shinichi