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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033226
Receipt No. R000037887
Official scientific title of the study Multi-institutional, prospective study of a combination therapy with androgen deprivation and external beam radiation therapy for hormone-sensitive metastatic prostate cancer
Date of disclosure of the study information 2018/07/09
Last modified on 2018/07/02

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Basic information
Official scientific title of the study Multi-institutional, prospective study of a combination therapy with androgen deprivation and external beam radiation therapy for hormone-sensitive metastatic prostate cancer
Title of the study (Brief title) Multi-institutional, prospective study of a combination therapy with androgen deprivation and external beam radiation therapy for hormone-sensitive metastatic prostate cancer
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Impact of ADT and EBRT for hormone-sensitive prostate cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Biochemical progression free survival
Key secondary outcomes Overall survival
Clinical progression-free survival
Cancer specific survival
Quality of life
Adverse events

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Extra beam radiation therapy(EBRT); intervention of EBRT for the prostate from 3 to 6 months after androgen deprivation therapy
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
85 years-old >=
Gender Male
Key inclusion criteria 1, metastatic prostate cancer
2, StageIV,(TMN;Tany, N1 and/or M1)
3, Performance status 0-1(ECOG PS)
4, Age >= 20, <=85
Key exclusion criteria 1, Had a prior malignancy. (Any other cancer for which treatment has been completed >= 5 years is allowed).
2, Other pathological findings except for aciner adenocarcinoma.
3, Use of steroid agents
Target sample size 80

Research contact person
Name of lead principal investigator Kawamorita Naoki
Organization Tohoku University Hospital
Division name Urology
Address 1-1 Seiryo-machi Aobaku Sendai Miyagi Japan
TEL 022-717-7278
Email kawamorita@uro.med.tohoku.ac.jp

Public contact
Name of contact person Kawamorita Naoki
Organization Tohoku University Hospital
Division name Urology
Address 1-1 Seiryo-machi Aobaku Sendai Miyagi Japan
TEL 022-717-7278
Homepage URL
Email kawamorita@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)

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
2018 Year 07 Month 09 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 01 Day
Anticipated trial start date
2018 Year 07 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 02 Day
Last modified on
2018 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037887

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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