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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002874
Receipt No. R000003506
Scientific Title Active surveillance for early prostate cancer: international study (PRIAS-JAPAN)
Date of disclosure of the study information 2009/12/11
Last modified on 2014/12/11

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Basic information
Public title Active surveillance for early prostate cancer: international study (PRIAS-JAPAN)
Acronym PRIAS-JAPAN
Scientific Title Active surveillance for early prostate cancer: international study (PRIAS-JAPAN)
Scientific Title:Acronym PRIAS-JAPAN
Region
Japan Europe

Condition
Condition Prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this research project is to study differences between men who elect immediate treatment and those who elect to postpone treatment for their prostate cancer. This will be measured by means of the need for treatment, spread of the cancer, death from prostate cancer and quality of life in Japanese patients. Also to validate the inclusion criteria and the follow-up protocol, and to compare the outcomes between races.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Actice surveillance remaining rate
Key secondary outcomes Clinical progression rate
Evidenced by metastasis
Disease specific survival
QOL

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

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1. Histologically proven adenocarcinoma of the prostate
2. Men should be fit for curative treatment
3. PSA-level at diagnosis< 10 ng/mL
4. PSA density (PSA D) less than 0,2
5. Clinical stage T1C or T2
6. Adequate biopsy sampling (see 'biopsy protocol')
7. Gleason score 3+3=6
8. One or 2 biopsy cores invaded with prostate cancer
9. Participants must be willing to attend the follow-up visits
Key exclusion criteria 1. Men who can not or do not want to be irradiated or operated
2. A former therapy for prostate cancer
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Kakehi
Organization Kagawa university
Division name Department of Urology
Zip code
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa pref. 761-0793
TEL +81-87-891-2202
Email kakehi@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mikio Sugimoto
Organization Kagawa university
Division name Department of Urology
Zip code
Address Kagawa pref.
TEL +81-87-891-2202
Homepage URL
Email micsugi@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa university
Institute
Department

Funding Source
Organization Kagawa university
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 香川大学医学部附属病院(香川県)

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 11 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
2009 Year 10 Month 06 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We are registrating participation institutes.

Management information
Registered date
2009 Year 12 Month 11 Day
Last modified on
2014 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003506

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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