1st Ra-223 Therapy Trial
- Conditions
- Castration-resistant prostate cancer (CRPC) with bone metastasesCastration-resistant prostate cancer (CRPC)MeSH Unique ID: D064129
- Registration Number
- JPRN-jRCTs031180442
- Lead Sponsor
- Sakamoto Shinichi
- Brief Summary
This trial was terminated due to poor recruitment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 4
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method