UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014328 |
|---|---|
| Receipt number | 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 08:40:31 |
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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
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
hirata@radonc.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016679
