Unique ID issued by UMIN | UMIN000035039 |
---|---|
Receipt number | R000039952 |
Scientific Title | Safety and efficacy of neoadjuvant chemohormonal therapy (low-dose estramustine plus LHRH agonist/antagonist) followed by extended radical prostatectomy for patients with high-risk localized prostate cancer |
Date of disclosure of the study information | 2018/12/15 |
Last modified on | 2018/11/30 23:57:25 |
Safety and efficacy of neoadjuvant chemohormonal therapy (low-dose estramustine plus LHRH agonist/antagonist) followed by extended radical prostatectomy for patients with high-risk localized prostate cancer
Neoadjuvant chemohormonal therapy followed by extended radical prostatectomy for high-risk localized PCa patients
Safety and efficacy of neoadjuvant chemohormonal therapy (low-dose estramustine plus LHRH agonist/antagonist) followed by extended radical prostatectomy for patients with high-risk localized prostate cancer
Neoadjuvant chemohormonal therapy followed by extended radical prostatectomy for high-risk localized PCa patients
Japan |
prostate cancer
Urology |
Malignancy
NO
Patients with advanced high-risk prostate cancer are prone to have worse pathological diagnoses of positive surgical margins and/or lymph node invasion, resulting in early biochemical recurrence despite having undergone radical prostatectomy. Therefore, it is controversial whether patients with high-risk prostate cancer should undergo radical prostatectomy. The purpose of this study was to evaluate the efficacy of neoadjuvant chemohormonal therapy followed by extended radical prostatectomy.
Safety,Efficacy
biochemical recurrence
overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
NO
NO
1
Treatment
Medicine | Other |
6 months of estramustine phosphate 280 mg bid, along with a luteinizing hormone-releasing hormone agonist/antagonist prior to extended radical prostatectomy.
Not applicable |
Not applicable |
Male
high-risk prostate cancer defined by D'amico's criteria
low or intermediate-risk prostate cancer defined by D'amico's criteria
80
1st name | |
Middle name | |
Last name | HIDEKI ENOKIDA |
Kagoshima University Hospital
Department of Urology
8-35-1 Sakuragaoka, Kagoshima, 890-8520, Japan
81-99-275-5395
henokida@m2.kufm.kagoshima-u.ac.jp
1st name | |
Middle name | |
Last name | HIDEKI ENOKIDA |
Kagoshima University Hospital
Department of Urology
8-35-1 Sakuragaoka, Kagoshima, 890-8520, Japan
81-99-275-5395
http://www.kufm.kagoshima-u.ac.jp/~urology/index.php
henokida@m2.kufm.kagoshima-u.ac.jp
Graduate School of Medical and Dental Sciences, Kagoshima University
N/A
Self funding
N/A
N/A
N/A
NO
Kagoshima University Hospital, Kagoshima, Japan
2018 | Year | 12 | Month | 15 | Day |
http://www.kufm.kagoshima-u.ac.jp/~urology/index.php
Unpublished
http://www.kufm.kagoshima-u.ac.jp/~urology/index.php
More than 1 year had elapsed after surgery in all 86 patients, with a median follow-up period of 3.1 years. Among these patients, 23 (26.7%) experienced biochemical recurrence. Multivariate Cox-regression analysis revealed that a positive core ratio of 50% or greater and pathological stage of pT3 or greater were independent predictors for BCR. Seventeen of 23 cases received salvage androgen deprivation therapy and concurrent external beam radiotherapy, and showed no progression after the salvage therapies.
Completed
2011 | Year | 10 | Month | 15 | Day |
2011 | Year | 11 | Month | 15 | Day |
2018 | Year | 03 | Month | 15 | Day |
2018 | Year | 03 | Month | 15 | Day |
2018 | Year | 03 | Month | 15 | Day |
2018 | Year | 07 | Month | 15 | Day |
N/A
2018 | Year | 11 | Month | 27 | Day |
2018 | Year | 11 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039952
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |