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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027581
Receipt No. R000031510
Scientific Title Safety and efficacy of neoadjuvant hormone therapy with combination of Estramustine Phosphate Sodium Hydrate and LH-RH agonist for high-risk prostate cancer treated with intensity modulated radiotherapy
Date of disclosure of the study information 2017/05/31
Last modified on 2017/12/01

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Basic information
Public title Safety and efficacy of neoadjuvant hormone therapy with combination of Estramustine Phosphate Sodium Hydrate and LH-RH agonist for high-risk prostate cancer treated with intensity modulated radiotherapy
Acronym neoadjuvant hormone therapy with combination of Estramustine Phosphate Sodium Hydrate for high-risk prostate cancer
Scientific Title Safety and efficacy of neoadjuvant hormone therapy with combination of Estramustine Phosphate Sodium Hydrate and LH-RH agonist for high-risk prostate cancer treated with intensity modulated radiotherapy
Scientific Title:Acronym neoadjuvant hormone therapy with combination of Estramustine Phosphate Sodium Hydrate for high-risk prostate cancer
Region
Japan

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

Objectives
Narrative objectives1 We evaluate biochemical free survival for patients with high-risk prostate cancer who treated with neoadjuvant hormone therapy combined Estramustine Phosphate Sodium Hydrate and LH-RH agonist before intensity modulated radiotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes biochemical recurrence free survival
Key secondary outcomes progression free survival, over all survival

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A principal investigator or subinvestigators make a decision of an agent for neodjuvant hormone therapy. Participants are treated with neoadjuvant hormone therapy for 6 months before intensity modulated radiotherapy. After radiotherapy they are folled for maximum 36 months without any hormone or anticancer agents.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1)PSA>20 or Gleason scores>=8 or Tumor stage T2c~T3(high risk prsotate cancer)
2)patients without history of hormone hterapies
3)ECOG Performance Status:0-1
4)patient's agreement to this study
5)men aged 20 years and older

Key exclusion criteria 1)patinets with another active cancers
2)patinets with severe cardiovascular diseases and diabetis militus
3)patients treated with 5a-reductase inhibitors for prostate hyperplasia
4)patientes treated with adrenocortical steroids
5)patinets with another anticancer agents
6)patients ineligible for this study judged by investigators
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshhide Kawasaki
Organization Tohoku University Graduate School of Medicine
Division name Department of Urology
Zip code
Address Seiryo-Machi 1-1 Aoba-Ku Sendai
TEL 022-717-7278
Email kawasaki@uro.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihide Kawasaki
Organization Tohoku University Graduate School of Medicine
Division name Department of Urology
Zip code
Address Seiryo-Machi 1-1 Aoba-Ku Sendai
TEL 022-717-7278
Homepage URL
Email kawasaki@uro.med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
This study was terminated because there were not any enrolled cases.
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 Terminated
Date of protocol fixation
2012 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 30 Day
Last follow-up date
2017 Year 11 Month 30 Day
Date of closure to data entry
2017 Year 11 Month 30 Day
Date trial data considered complete
2017 Year 11 Month 30 Day
Date analysis concluded
2017 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 31 Day
Last modified on
2017 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031510

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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