NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000333

Registered date:01/03/2006

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 )

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedProstate Cancer
Date of first enrollment2002/05/01
Target sample size4000
Countries of recruitmentJapan
Study typeObservational
Intervention(s)

Outcome(s)

Primary Outcome1.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.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale
Include 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.
Exclude criteriaNone

Related Information

Contact

public contact
Name Ryoko Fukunaga
Address 3-1-1 Maidashi higashi-ku, Fukuoka 812-8582 Japan
Telephone 092-642-5603
E-mail hinyoki@uro.med.kyushu-u.ac.jp
Affiliation Graduate School of Medical Sciences, Kyusyu University Department of Urology
scientific contact
Name Seiji Naito
Address 3-1-1 Maidashi higashi-ku, Fukuoka 812-8582 Japan
Telephone 092-642-5603
E-mail hinyoki@uro.med.kyushu-u.ac.jp
Affiliation Graduate School of Medical Sciences, Kyusyu University Department of Urology