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 2022/04/18 16:15:11

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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

Email

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


Email

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

Email

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

Open public recruiting

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

2022 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033636


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name