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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000333
Receipt No. R000000426
Scientific Title A multicentre study in patients with localised prostate cancer for prediction of pathological stage of the radical prostatectomy and assessment of predictive factors of postoperative-recurrent.( Development of a Japanese Prostate Cancer Nomogram )
Date of disclosure of the study information 2006/03/01
Last modified on 2015/02/18

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Basic information
Public title A multicentre study in patients with localised prostate cancer for prediction of pathological stage of the radical prostatectomy and assessment of predictive factors of postoperative-recurrent.( Development of a Japanese Prostate Cancer Nomogram )
Acronym A multicentre study in patients with localised prostate cancer for prediction of pathological stage of the radical prostatectomy and assessment of prediction factors of postoperative-recurrent.( Development of a Japanese Prostate Cancer Nomogram )
Scientific Title A multicentre study in patients with localised prostate cancer for prediction of pathological stage of the radical prostatectomy and assessment of predictive factors of postoperative-recurrent.( Development of a Japanese Prostate Cancer Nomogram )
Scientific Title:Acronym A multicentre study in patients with localised prostate cancer for prediction of pathological stage of the radical prostatectomy and assessment of prediction factors of postoperative-recurrent.( Development of a Japanese Prostate Cancer Nomogram )
Region
Japan

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

Objectives
Narrative objectives1 To identify biological characteristics of localised prostate cancer in Japanese patients and to examine the possibility of prediction of postoperative pathological stage or recurrence after treatment. Furthermore, to create Japanese version Prostate Cancer Nomogram aiming at improvement in medical treatment outcome.
Basic objectives2 Others
Basic objectives -Others To identify biological characteristics of localised prostate cancer in Japanese patients and to examine the possibility of prediction of postoperative pathological stage or recurrence after treatment. Furthermore, to create Japanese version Prostate Cancer Nomogram aiming at improvement in medical treatment outcome.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1.Comparison of preoperative clinical data and histopathological findings of the biopsy specimen with histopathological findings of the radical prostatectomy specimen. 2.Prediction of PSA recurrence by the preoperative clinical data and histopathological findings of the biopsy specimen.
3.Prediction of PSA recurrence by histopathological findings of the radical prostatectomy specimen.
Key secondary outcomes

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 [ Prospective study ]
1.Patients with localised prostate cancer who received radical prostatectomy (including laparoscopic surgery ) on and after 1st May 2002 (regardless of enforcement of neo-adjuvant therapy and adjuvant therapy).
2.Patients with PSA measurement by the equimolar PSA kit ( except for Merkit-M ) before enforcement of radical prostatectomy. 3.Patients with at least six or more systematic biopsies enforced under the ultrasonic guide.
4.Patients with evaluable clinical stage by TNM classification of malignant tumors ( UICC 1992.Ver.4 ).
5.Patients whose follow-up observation is possible, while measuring PSA periodically after enforcement of radical prostatectomy. (However, follow-up will not be done for patients who undergone adjuvant therapy.)
The following patients who filled all of these five conditions.
A: Neo-Adjuvant hormone therapy non-enforcing patients.
B: Neo-Adjuvant hormone therapy enforcement patients. (Regardless of contents and period )

[ Retrospective study ]
1.Patients with localised prostate cancer patients who underwent radical prostatectomy (including laparoscopic surgery ) from 1st January 1997 to 30th April 2002 (Regardless of neo-adjuvant therapy and adjuvant therapy).
2.And other items are the same as the prospective study, except for the same standards for a positive study will be applied.
Key exclusion criteria None
Target sample size 4000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiji Naito
Organization Graduate School of Medical Sciences, Kyusyu University
Division name Department of Urology
Zip code
Address 3-1-1 Maidashi higashi-ku, Fukuoka 812-8582
TEL 092-642-5603
Email hinyoki@uro.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoko Fukunaga
Organization Graduate School of Medical Sciences, Kyusyu University
Division name Department of Urology
Zip code
Address 3-1-1 Maidashi higashi-ku, Fukuoka 812-8582
TEL 092-642-5603
Homepage URL
Email hinyoki@uro.med.kyushu-u.ac.jp

Sponsor
Institute Clinicopathological Research Group for Localized Prostate Cancer (CRPC)
Institute
Department

Funding Source
Organization Clinical Research Foundation
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
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

Other administrative information
Date of disclosure of the study information
2006 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.jurology.com/issues
Number of participants that the trial has enrolled
Results
The Journal of Urology, 
Volume 180, Issue 3, Pages 904-910, (September 2008)

Purpose: We validated the 2001 Partin tables and developed an original nomogram for Japanese patients using the 2005 International Society of Urological Pathology consensus on Gleason grading.
Materials and Methods: Prostatectomy specimens from 1,188 Japanese men who underwent radical prostatectomy for clinically localized prostate cancer (cT1-2) between 1997 and 2005 were analyzed. Polychotomous logistic regression analysis was used to construct a nomogram to predict final pathological stage (organ confined disease, extraprostatic extension, seminal vesicle invasion and lymph node involvement) from 3 variables, including serum prostate specific antigen, clinical stage and biopsy Gleason score. The area under the ROC curve was used to compare the new nomogram with the Partin tables.
Results: Preoperative serum prostate specific antigen and biopsy Gleason score were higher in the Japanese cohort than in the Partin cohort. The distribution of clinical and final pathological stages was similar in the 2 cohorts. The AUC for predicting organ confined disease was 0.699 and 0.717 for data applied to the Partin tables and to the new nomogram, respectively. The AUC for predicting lymph node involvement was 0.793 and 0.863, respectively.
Conclusions: To our knowledge this is the first preoperative nomogram developed for clinically localized prostate cancer in Japanese patients. Although the new nomogram predicted the pathological stage of prostate cancer in Japanese patients more accurately than the Partin tables, it did not satisfactorily predict organ confined disease. However, other predictive variables, such as more detailed pathological features of biopsy specimens or magnetic resonance imaging, may further improve prediction accuracy.
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 No longer recruiting
Date of protocol fixation
2002 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2002 Year 05 Month 01 Day
Last follow-up date
2008 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Participating investigator reports PSA recurrence and survival status every 12 months. However, follow up study is not carried out about adjuvant therapy patients.

Management information
Registered date
2006 Year 02 Month 17 Day
Last modified on
2015 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000426

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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