UMIN-CTR Clinical Trial

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

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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 or person

Institute

Graduate School of Medical and Dental Sciences, Kagoshima University

Institute

Department

Personal name



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

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