Japan nation-wide registry for Metastatic castration-resistant prostate cancer with BOne metastasis(JMBO)

Japan nation-wide registry for Metastatic castration-resistant prostate cancer with BOne metastasis(JMBO) - JMBO study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000029509

Enrollment

300

Registered

2018-02-01

Start date

2018-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Castration-resistant prostate cancer with bone metastasis

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1 Ability to understand and the willingness to sign a written informed consent(IC) 2 Histologically or cytologically confirmed adenocarcinoma of the prostate 3 Medical or surgical castration 4 Serum PSA value >=1ng/mL 5 Multiple bone metastases(>=2 hot spots)bone scintigraphy within previous 12 weeks 6 Age>=20years 7 ECOG PS score of 0 to 1(PS 2 caused by symptoms from bone metastasis is permitted) 8 Life expectancy of>=6months 9 Life expectancy of>=6months

Exclusion criteria

Exclusion criteria: 1 Prior chemotherapy after dignosis of CRPC(except for UFT or EMT) 2 Prior hemibody extemal radiotherapy 3 Prior treatment with Stontium-89 for bone metastasis within 24 weeks from enrollment 4 Prior treatment with radium-223 5 Has history of gastrointestenal bleeding prior study entry 6 Any active other malignancy 7 History of visceral metastasis or presence of visceral metastasis detected by screening imaging examinations 8 History of or known brain metastasis 9 Malignant lymphadenopathy exceeding 3cm in shortaxis diameter 10 Imminent or established spinal cord compression based on clinical findings and/or MRI(Magnetic Resonance Imaging) 11 Any other serious illness or medical condition 12 Substance abuse,medical,psychological,or social conditions that may interfere with the subject's participation in the study or evaluation of the study results

Design outcomes

Primary

Measure	Time frame
Treatment pattern (drugs used and their sequence) from diagnosis of CRPC to the end of follow-up in CRPC patients with bone metastasis and without visceral metastasis	—

Secondary

Measure	Time frame
1) Overall survival 2) Time to initiation of chemotherapy 3) Time to visceral metastasis 4) Time to SSE (symptomatic skeletal event) 5) Laboratory findings (e.g. ALP, bone markers) in overall population 6) QOL (EORTC-QLQ-c30, QLQ-BM22) 7) Bone Scan Index 8) Safety in Ra-223 patients	—

Countries

Japan

Contacts

Public ContactChiyo Kosaka

The Japanese Urological Association Director

office@urol.or.jp03-3814-7921

Outcome results