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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006612
Receipt No. R000007344
Scientific Title To evaluate efficacy of image-guided intensity modulated radiotherapy using fiducial gold markers for localized advanced prostate cancer
Date of disclosure of the study information 2011/11/01
Last modified on 2012/06/19

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Basic information
Public title To evaluate efficacy of image-guided intensity modulated radiotherapy using fiducial gold markers for localized advanced prostate cancer
Acronym To evaluate efficacy of image-guided IMRT using fiducial gold markers for prostate cancer
Scientific Title To evaluate efficacy of image-guided intensity modulated radiotherapy using fiducial gold markers for localized advanced prostate cancer
Scientific Title:Acronym To evaluate efficacy of image-guided IMRT using fiducial gold markers for prostate cancer
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of image-guided intensity modulated radiotherapy of 76-80Gy in 38-40 fractions using fiducial gold markers for localized advanced prostate cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Biochemical relapse free survival
Cause-specific survival
Overall survival
Toxicity
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Patients are treated with image-guided IMRT (76-80Gy/38-40fx.) using fiducial gold markers in the prostate
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1) Prostate adenocarcinoma is proven.
2) Patient should receive MRI examination before treatment.
3) cT1-T3bN0M0, Gleason score &#8805;8,pretreatment PSA >20ng/ml
4) ECOG PS 0-1
5) Patients must sign informed consent form prior to registration
Key exclusion criteria 1) Prior pelvic radiotherapy
2) Small cell carcinoma
3) cT4, exist of metastasis
4) Prior prostatectomy
5) Concurrent invasive cancers or collagen disease
6) PSA failure following hormonal therapy
7) If the attending physician judges the case inappropriate.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Takeda M.D., Ph.D.
Organization Health Sciences, Tohoku University Graduate School of Medicine
Division name Department of Therapeutic Radiology
Zip code
Address 2-1, Seiryomachi, Aobaku, Senddaishi, 980-8575, Japan
TEL 022-717-7939
Email

Public contact
Name of contact person
1st name
Middle name
Last name Haruo Matsushita M.D., Ph.D.
Organization Tohoku University Hospital
Division name Department of Radiation Oncology
Zip code
Address 1-1, Seiryomachi, Aobaku, Sendaishi,980-8574, Japan
TEL 022-717-7312
Homepage URL
Email harumatsu2001@yahoo.co.jp

Sponsor
Institute Department of Radiation Oncology, Tohoku University Hospital
Institute
Department

Funding Source
Organization Tohoku University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 東北大学病院

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 01 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
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 Open public recruiting
Date of protocol fixation
2011 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 25 Day
Last modified on
2012 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007344

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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