UMIN-CTR Clinical Trial

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	2019 Year 01 Month 10 Day

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