UMIN-CTR Clinical Trial

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

Prostate Cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Clinicopathological Research Group for Localized Prostate Cancer (CRPC)

Institute

Department

Personal name

Organization

Clinical Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2006

Year

03

Month

01

Day

URL releasing protocol

Publication of results

Partially published

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

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 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.

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