UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040809
Receipt number R000046593
Scientific Title Nationwide Japanese prostate cancer outcome study of permanent Iodine-125 seed implantation (J-POPS): Paper questionnaire sent by mail-based longevity survey
Date of disclosure of the study information 2020/06/17
Last modified on 2021/06/12 08:34:42

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Basic information

Public title

Nationwide Japanese prostate cancer outcome study of permanent Iodine-125
seed implantation (J-POPS): Medical record-based longevity survey

Acronym

J-POPS: Paper questionnaire sent by mail-based longevity survey

Scientific Title

Nationwide Japanese prostate cancer outcome study of permanent Iodine-125 seed implantation (J-POPS): Paper questionnaire sent by mail-based longevity survey

Scientific Title:Acronym

J-POPS: Paper questionnaire sent by mail-based longevity survey

Region

Japan


Condition

Condition

prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate prognosis in patients who underwent 125I -brachytherapy for prostate cancer with long-term follow-up in Japan including patients lost to follow-up.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival

Key secondary outcomes

biochemical progression-free survival, clinical progression-free survival, freedom from treatment failure, time to biochemical progression, time to clinical progression, disease-specific survival, metastasis-free survival,time to castration resistant prostate cancer


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

Patients enrolled in Nationwide Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation

Key exclusion criteria

Patients without informed consent

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Tanaka
Middle name
Last name Nobumichi

Organization

Nara Medical University

Division name

Department of Urology

Zip code

634-8521

Address

Shijyocho 840 Kashihara Nara

TEL

0744-22-3051

Email

sendo@naramed-u.ac.jp


Public contact

Name of contact person

1st name Nakai
Middle name
Last name Yasushi

Organization

Nara Medical University

Division name

Department of Urology

Zip code

634-8521

Address

Shijyocho 840 Kashihara Nara

TEL

0744-22-3051

Homepage URL


Email

nakaiyasushi@naramed-u.ac.jp


Sponsor or person

Institute

The Japanese Prostate Permanent Seed Implantation Study Group

Institute

Department

Personal name



Funding Source

Organization

The Japanese Prostate Permanent Seed Implantation Study Group

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

the ethics committee of Nara Medical university

Address

Shijyocho 840 Kashihara Nara

Tel

0744-22-3051

Email

ino_rinri@naramed-u.ac.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



Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 17 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

Enrolling by invitation

Date of protocol fixation

2020 Year 04 Month 06 Day

Date of IRB

2020 Year 09 Month 08 Day

Anticipated trial start date

2020 Year 07 Month 01 Day

Last follow-up date

2030 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Status of health, treatment for prostate cancer, the kinds of treatment, the date of treatment, hospitalization, and death, cause of death, others


Management information

Registered date

2020 Year 06 Month 17 Day

Last modified on

2021 Year 06 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046593


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name