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

1st Ra-223 Therapy Trial

4

This trial enrolled 4 males aged 70 to 86 years. The mean age was 78.5 years.

This trial enrolled 4 patients. All patients were discontinued before study drug administration.

No adverse events were observed.

Statistical analysis was not performed because no patients received study drug.

This trial was terminated due to poor recruitment.

June. 07, 2021

No

No

https://jrct.niph.go.jp/latest-detail/jRCTs031180442

Sakamoto Shinichi

Chiba University Hospital

Chiba

rbatbat1@chiba-u.jp

Sakamoto Shinichi

Chiba University Hospital

1-8-1 Inohana Chuou-ku, Chiba, Chiba

+81-432262134

rbatbat1@chiba-u.jp

Complete

Jan. 01, 2018

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

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

Male

Castration-resistant prostate cancer (CRPC) with bone metastases

Ra-223 (55 kBq/kg i.v.) 6 injections at 4 weeks interval in combination with flutamide and bone modifying agent.

Castration-resistant prostate cancer (CRPC)

MeSH Unique ID: D064129

MeSH Unique ID: C000615150

% change in ALP at 12week

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

+81-43-222-7171

Feb. 20, 2019

None