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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009876
Receipt No. R000011573
Scientific Title Clinical significance of [-2]proPSA during active surveillance for localized prostate cancer
Date of disclosure of the study information 2013/01/25
Last modified on 2019/08/01

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Basic information
Public title Clinical significance of [-2]proPSA during active surveillance for localized prostate cancer
Acronym [-2]proPSA during active surveillance for prostate cancer
Scientific Title Clinical significance of [-2]proPSA during active surveillance for localized prostate cancer
Scientific Title:Acronym [-2]proPSA during active surveillance for prostate cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the clinical significance of [-2]proPSA during active surveillance for localized prostate cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes reclassification at repeat biopsy
Key secondary outcomes 1)reclassification at secondary radical prostatectomy specimen
2)active surveillance remaining rate
3)clinical progression
4)distant metastasis
5)overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 periodical prostate biopsy
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
50 years-old <=
Age-upper limit
80 years-old >=
Gender Male
Key inclusion criteria 1. Histologically proven adenocarcinoma of the prostate
2. patient 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. Appropriate biopsy sampling7. Gleason score 3+3=6 (or less)
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. Patient who can not or do not want to be radiated or operated
2. Previously treated for prostate cancer
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Mikio
Middle name
Last name Sugimoto
Organization Kagawa University
Division name Urology
Zip code 7610793
Address 1750-1 Ikenobe Miki-cho Kita-gun Kagawa
TEL 087-891-2202
Email kakehi@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name Takuma
Middle name
Last name Kato
Organization Kagawa University
Division name Urology
Zip code 7610793
Address 1750-1 Ikenobe Miki-cho Kita-gun Kagawa
TEL 087-891-2202
Homepage URL
Email micsugi@med.kagawa-u.ac.jp

Sponsor
Institute Department of Urology, Kagawa University
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Kagawa University
Address 1750-1 Ikenobe Miki-cho Kita-gun Kagawa
Tel 0878985111
Email micsugi@med.kagawa-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 香川大学医学部附属病院(香川県)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 25 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
2013 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 16 Day
Last follow-up date
2018 Year 01 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 25 Day
Last modified on
2019 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011573

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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