UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000333 |
|---|---|
| Receipt number | 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 | 2023/03/06 10:35:12 |
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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
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
hinyoki@uro.med.kyushu-u.ac.jp
Sponsor or person
Institute
Clinicopathological Research Group for Localized Prostate Cancer (CRPC)
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2002 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2002 | Year | 06 | Month | 05 | Day |
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
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000426
