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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035039
Receipt No. 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

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Basic information
Public 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
Acronym Neoadjuvant chemohormonal therapy followed by extended radical prostatectomy for high-risk localized PCa patients
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
Scientific Title:Acronym Neoadjuvant chemohormonal therapy followed by extended radical prostatectomy for high-risk localized PCa patients
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes biochemical recurrence
Key secondary outcomes overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Other
Interventions/Control_1 6 months of estramustine phosphate 280 mg bid, along with a luteinizing hormone-releasing hormone agonist/antagonist prior to extended radical prostatectomy.
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 high-risk prostate cancer defined by D'amico's criteria
Key exclusion criteria low or intermediate-risk prostate cancer defined by D'amico's criteria
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name HIDEKI ENOKIDA
Organization Kagoshima University Hospital
Division name Department of Urology
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima, 890-8520, Japan
TEL 81-99-275-5395
Email henokida@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name HIDEKI ENOKIDA
Organization Kagoshima University Hospital
Division name Department of Urology
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima, 890-8520, Japan
TEL 81-99-275-5395
Homepage URL http://www.kufm.kagoshima-u.ac.jp/~urology/index.php
Email henokida@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute Graduate School of Medical and Dental Sciences, Kagoshima University
Institute
Department

Funding Source
Organization N/A
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization N/A

Other related organizations
Co-sponsor N/A
Name of secondary funder(s) N/A

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 Kagoshima University Hospital, Kagoshima, Japan

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 15 Day

Related information
URL releasing protocol http://www.kufm.kagoshima-u.ac.jp/~urology/index.php
Publication of results Unpublished

Result
URL related to results and publications http://www.kufm.kagoshima-u.ac.jp/~urology/index.php
Number of participants that the trial has enrolled
Results
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.
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
2011 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 15 Day
Last follow-up date
2018 Year 03 Month 15 Day
Date of closure to data entry
2018 Year 03 Month 15 Day
Date trial data considered complete
2018 Year 03 Month 15 Day
Date analysis concluded
2018 Year 07 Month 15 Day

Other
Other related information N/A

Management information
Registered date
2018 Year 11 Month 27 Day
Last modified on
2018 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.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


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