UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000570 |
|---|---|
| Receipt number | R000000689 |
| Scientific Title | Follow-up study for localized prostate cancer treated by hormonal therapy or radical prostatectomy. |
| Date of disclosure of the study information | 2006/12/30 |
| Last modified on | 2006/12/29 20:19:54 |
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Basic information
Public title
Follow-up study for localized prostate cancer treated by hormonal therapy or radical prostatectomy.
Acronym
J-CaP IS-1 study
Scientific Title
Follow-up study for localized prostate cancer treated by hormonal therapy or radical prostatectomy.
Scientific Title:Acronym
J-CaP IS-1 study
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of hormonal therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Cause specific survival
Failure(recurrence) free survival
Quality of Life
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
| 67 | years-old | <= |
Age-upper limit
| 76 | years-old | >= |
Gender
Male
Key inclusion criteria
T1c or T2N0M0
No prior therapy for prostate cancer
PSA value < 20ng/ml
Gleason score 7 or lower
No neo-adjuvant hormonal therapy
Wirtten informed consented
Key exclusion criteria
Nothing
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Akaza, Michiyuki Usami, Mikio Namiki |
Organization
University of Tsukuba, University of Tsukuba, Osaka Medical Center for Cardiovascular disease, Kanazawa University
Division name
Department of Urology
Zip code
Address
Tsukuba, Osaka, Kanazawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Akaza M.D. |
Organization
University of Tsukuba
Division name
Department of Urology
Zip code
Address
TEL
Homepage URL
http://www.j-cap.net
Sponsor or person
Institute
J-CaP study group
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2006 | Year | 12 | Month | 30 | 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
Date of protocol fixation
| 2006 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
PSA failure, Clinical failure and recurrence
Management information
Registered date
| 2006 | Year | 12 | Month | 29 | Day |
Last modified on
| 2006 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000689
