UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029509 |
|---|---|
| Receipt number | R000033636 |
| Scientific Title | Japan nation-wide registry for Metastatic castration-resistant prostate cancer with BOne metastasis(JMBO) |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2024/08/09 10:09:48 |
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Basic information
Public title
Japan nation-wide registry for Metastatic castration-resistant prostate cancer with BOne metastasis(JMBO)
Acronym
JMBO study
Scientific Title
Japan nation-wide registry for Metastatic castration-resistant prostate cancer with BOne metastasis(JMBO)
Scientific Title:Acronym
JMBO study
Region
| Japan |
Condition
Condition
Castration-resistant prostate cancer with bone metastasis
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the real-world practice pattern in the CRPC patients with bone metastasis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key 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
Key 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
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Uemura MD, PhD |
Organization
Kindai Univercity
Division name
Department of Urology, School of Medicine
Zip code
5898511
Address
377-2 Ohnohigashi, Osakasayama City, Osaka 589-8511, JAPAN
TEL
072-366-0221
huemura@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Chiyo |
| Middle name | |
| Last name | Kosaka |
Organization
The Japanese Urological Association
Division name
Director
Zip code
113-0034
Address
5F Saito building 2-17-15 Yushima Bunkyo-Ku, Tokyo, 113-0034,Japan
TEL
03-3814-7921
Homepage URL
office@urol.or.jp
Sponsor or person
Institute
The Japanese Urological Association
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Japanese Urological Association
Address
5F Saito building 2-17-15 Yushima Bunkyo-Ku, Tokyo, 113-0034,Japan
Tel
03-3841-7921
office@urol.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
旭川医科大学病院（北海道）、北海道大学病院(北海道)、札幌医科大学附属病院（北海道）、北海道がんセンター（北海道）、弘前大学医学部附属病院（青森県）、岩手医科大学附属病院（岩手県）、筑波大学附属病院（茨城県）獨協医科大学病院(栃木県)、国際医療福祉大学（栃木県）、群馬大学医学部附属病院（群馬県）、獨協医科大学埼玉医療センター(埼玉県)、埼玉医科大学国際医療センター（埼玉県）、千葉大学医学部附属病院（千葉県）、東邦大学医療センター佐倉病院（千葉県）、千葉県がんセンター（千葉県）、順天堂大学医学部附属順天堂医院（東京都）、慶應義塾大学病院（東京都）、日本大学医学部附属板橋病院（東京都）、東京医科大学病院（東京都）、東京慈恵会医科大学附属病院（東京都）、東京大学医学部附属病院（東京都）、東京医科歯科大学医学部附属病院（東京都）、東邦大学医療センター大森病院（東京都）、昭和大学病院（東京都）、帝京大学医学部附属病院（東京都）、聖マリアンナ医科大学病院（神奈川県）、東海大学医学部付属病院（神奈川県）、横浜市立大学附属病院(神奈川県)、横浜市立大学附属市民総合医療センター（神奈川県）、新潟大学医歯学総合病院（新潟県）、富山大学付属病院（富山県）、金沢大学附属病院（石川県）、金沢医科大学病院(石川県)、山梨大学医学部附属病院（山梨県）、浜松医科大学医学部附属病院（静岡県）、名古屋大学医学部附属病院(愛知県)、名古屋市立大学病院（愛知県）、愛知医科大学病院（愛知県）、滋賀医科大学医学部附属病院（滋賀県）、京都府立医科大学附属病院(京都府)、関西医科大学附属病院（大阪府）、大阪医科大学附属病院(大阪府)、近畿大学医学部附属病院（大阪府）、兵庫医科大学病院（兵庫県）、神戸大学医学部附属病院(兵庫県)、和歌山県立医科大学附属病院（和歌山県）、島根大学医学部附属病院(島根県)、川崎医科大学附属病院(岡山県)、広島大学病院（広島県）、山口大学医学部附属病院（山口県）、徳島大学病院（徳島県）、香川大学医学部附属病院（香川県）、愛媛大学医学部附属病院（愛媛県）、高知大学医学部附属病院（高知県）、九州大学病院(福岡県)、佐賀大学医学部附属病院（佐賀県）、長崎大学病院（長崎県）、大分大学医学部附属病院（大分県）、鹿児島大学病院（鹿児島県）、琉球大学医学部附属病院（沖縄県）、自治医科大学附属病院（栃木県）、埼玉医科大学総合医療センター（埼玉県）、独立行政法人国立病院機構埼玉病院（埼玉県）、東京新宿メディカルセンター（東京都）、大阪市立大学医学部附属病院（大阪府）、奈良県立医科大学（奈良県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Correlation between real-life treatment pattern (drugs used and their sequence) and the following outcomes in CRPC patients with bone metastasis will be evaluated.
(1) Overall survival
(2) Time to initiation of chemotherapy
(3) Time to visceral metastasis
(4) Time to SSE
(5) Laboratory findings (e.g. ALP, PSA, and bone markers)
(6) QOL (EORTC-QLQ-c30, QLQ-BM22)
(7) Bone Scan Index
(8) Safety in Ra-223 patients
Management information
Registered date
| 2017 | Year | 10 | Month | 11 | Day |
Last modified on
| 2024 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033636
