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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014328
Receipt No. R000016679
Scientific Title Hypofractionated radiotherapy for low and intermediate-risk prostate cancer using robot-tracking stereotactic radiotherapy -phase I/II clinical trial-
Date of disclosure of the study information 2014/06/20
Last modified on 2019/09/01

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Basic information
Public title Hypofractionated radiotherapy for low and intermediate-risk prostate cancer using robot-tracking stereotactic radiotherapy -phase I/II clinical trial-
Acronym Robot-tracking stereotactic radiotherapy for prostate cancer
Scientific Title Hypofractionated radiotherapy for low and intermediate-risk prostate cancer using robot-tracking stereotactic radiotherapy -phase I/II clinical trial-
Scientific Title:Acronym Robot-tracking stereotactic radiotherapy for prostate cancer
Region
Japan

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

Objectives
Narrative objectives1 To seek for optimal dose-fractionation and to evaluate safety and efficacy of hypfractionated short-term radiotherapy for low and intermediate-risk prostate cancer, using robotic streotactic radiotherapy machine equipped with a tumor-chasing device
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Ratio of 2-year late adverse events (genitourinary and gaastrointestinal Grade 2 or more)
Key secondary outcomes 2-year biochemical control rate, QOL questionnaire (EPIC + SF-8), dosimetry (dose distribution etc. in radiation physics)

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
Other
Interventions/Control_1 1st dose level (7 Gy x 5 fractions = 35 Gy), 2nd dose level (7.5 Gy x 5 fractions = 37.5 Gy), 3rd dose level (8 Gy x 5 fractions = 40 Gy)
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
80 years-old >
Gender Male
Key inclusion criteria 1) Biopsy-proven adenocarcinoma
2) no lymph node metastasis or distant metastasis proven by all of MRI, CT and bone scan
3) T1c-T2cN0M0
4) GS <=7
5) PSA <=20
6) No hormone therapy or less than 1-year neoadjuvant hormone therapy
7) WBC>3,000, Hb >10, Plt >10000, Cr <2, GOT <100, GPT<100
8) Age >20, <80
9) Informed consent
Key exclusion criteria 1) Active double cancer
2) Uncontrollable DM
3) Impossible to stop anticoagulate drugs
4) Severe brain disease
5) Collagen disease
6) Previous pelvic surgery or radiotherapy
7) Previous TUR-P
8) Severe BPH or dysuria
9) Disagree to implant of metallic marker
10) Hormone therapy > 1 year
11) Castration-resistant prostate cancer
12) PSA >20
13) Physician-rated contraindication
Target sample size 75

Research contact person
Name of lead principal investigator
1st name Takero
Middle name
Last name Hirata
Organization Osaka University Graduate School of Medicine
Division name Radiation Oncology
Zip code 5650871
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3482
Email hirata@radonc.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Takero
Middle name
Last name Hirata
Organization Osaka University Graduate School of Medicine
Division name Radiation Oncology
Zip code 5650871
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3482
Homepage URL
Email hirata@radonc.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Osaka University Graduate School of Medicine
Address 2-2 Yamadaoka, Suita, Osaka
Tel 06-6879-3345
Email nakano-k@office.osaka-u.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
2014 Year 06 Month 20 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 No longer recruiting
Date of protocol fixation
2014 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 23 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
2014 Year 06 Month 20 Day
Last modified on
2019 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016679

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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