UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028402 |
|---|---|
| Receipt number | R000032250 |
| Scientific Title | Robotic stereotactic body radiotherapy for prostate cancer |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2021/05/20 11:40:58 |
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Basic information
Public title
Robotic stereotactic body radiotherapy for prostate cancer
Acronym
Robotic stereotactic body radiotherapy for prostate cancer
Scientific Title
Robotic stereotactic body radiotherapy for prostate cancer
Scientific Title:Acronym
Robotic stereotactic body radiotherapy 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 safety and effectiveness of hypofractionated robotic stereotactic body radiotherapy for localized prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2-year late genitourinary and gastrointestinal toxicity rates
Key secondary outcomes
2-year biochemical failure-free survival, QOL
(EPIC, IPSS), and dosimetry
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 |
Interventions/Control_1
Stereotactic body radiotherapy. 36.25Gy/5fr.
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 prostate adenocarcinoma
2)MRI, CT, bone scintigraphy were done, and no lymph node or distant metastasis was detected
3)T1c-T2cN0M0
4)Gleason score=7 or less, excluding 4+3
5)PSA <20 ng/ml
6)Well preserved major organ function fulfilling laboratory test limits as below
a)White blood cell count>=3000/mm3
b)Hemoglobin>=10.0g/dl
c)Platelet count>=100000/mm3
d)Serum creatinine<=2.0mg/dl
e)GOT<=100U/L
f)GPT<=100U/L
g)No apparent deficiency of hematological tests
7)Age >=20, <80
8)Written informed consent obtained
Key exclusion criteria
1)Associated with other malignancies
2)Diabetes mellitus uncontrollable with medication
3)Unstoppable anticoagulant drugs
4)Severe neurocognitive disease
5)Collagen disease
6)Previous surgery or irradiation to the pelvis
7)Previous TUR-P
8)Severe BPH or lower urinaly tract symptoms
9)Contraindicated for percutaneous fiducial insertion
10)Neoadjucant hormone therapy >1 year
11)Castration-resistant prostate cancer
12)Miscellaneous inappropriate conditions judged by physicians
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahisa Eriguchi |
Organization
Saiseikai Yokohama City Tobu Hospital
Division name
Department of radiation oncology
Zip code
Address
3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa, Japan
TEL
045-576-3000
t_eriguchi@tobu.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahisa Eriguchi |
Organization
Saiseikai Yokohama City Tobu Hospital
Division name
Department of radiation oncology
Zip code
Address
3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa, Japan
TEL
045-576-3000
Homepage URL
t_eriguchi@tobu.saiseikai.or.jp
Sponsor or person
Institute
Saiseikai Yokohama City Tobu Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 08 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 27 | Day |
Last modified on
| 2021 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032250
