UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027581 |
|---|---|
| Receipt number | 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 | 2020/01/06 10:42:33 |
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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 | Yoshhide |
| Middle name | |
| Last name | Kawasaki |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Urology
Zip code
9808574
Address
Seiryo-Machi 1-1 Aoba-Ku Sendai
TEL
022-717-7278
kawasaki@uro.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yoshhide |
| Middle name | |
| Last name | Kawasaki |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Urology
Zip code
9808574
Address
Seiryo-Machi 1-1 Aoba-Ku Sendai
TEL
022-717-7278
Homepage URL
kawasaki@uro.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
Tohoku University Graduate School of Medicine
Address
Seiryo-Machi 1-1 Aoba-Ku Sendai
Tel
022-717-7278
kawasaki@uro.med.tohoku.ac.jp
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
This study was terminated because there were not any enrolled cases.
Publication of results
Unpublished
Result
URL related to results and publications
This study was terminated because there were not any enrolled cases.
Number of participants that the trial has enrolled
0
Results
This study was terminated because there were not any enrolled cases.
Results date posted
| 2020 | Year | 01 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study was terminated because there were not any enrolled cases.
Participant flow
This study was terminated because there were not any enrolled cases.
Adverse events
This study was terminated because there were not any enrolled cases.
Outcome measures
This study was terminated because there were not any enrolled cases.
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
| 2017 | Year | 06 | Month | 15 | Day |
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
| 2020 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031510
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
