1st Ra-223 Therapy Trial

JRCT ID: jRCTs031180442

Registered date:28/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Castration-resistant prostate cancer (CRPC) with bone metastases
• Date of first enrollment: 19/03/2018
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Ra-223 (55 kBq/kg i.v.) 6 injections at 4 weeks interval in combination with flutamide and bone modifying agent.

Outcome(s)

• Primary Outcome: % change in ALP at 12week

Secondary Outcome

1. % change in ALP at 24week
2. % change in PSA at 12 and 24weeks
3. % changes in Bone markers (BAP, TRACP-5B) at 12 and 24 weeks
4. Bone Scan Index (BSI)
5. QOL( EQ-5D-5L, Japanese Brief Pain Inventory (BPI-J) )
6. Completion rate of Ra-223 administration
7. Overall Survival (OS)
8. Symptomatic Skeletal Events-Free Survival (SSE-FS)
9. Time to visceral metastases
10. Fracture
11. Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Sakamoto Shinichi
• Source(s) of Monetary Support: Bayer Yakuhin, Ltd,Bayer Yakuhin, Ltd
• Secondary ID(s): UMIN000030946