UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028402
Receipt No. R000032250
Scientific Title Robotic stereotactic body radiotherapy for prostate cancer
Date of disclosure of the study information 2017/08/01
Last modified on 2018/01/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last 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
Email t_eriguchi@tobu.saiseikai.or.jp

Public contact
1st 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
Email t_eriguchi@tobu.saiseikai.or.jp

Sponsor
Institute Saiseikai Yokohama City Tobu Hospital
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)

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

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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 08 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
2017 Year 07 Month 27 Day
Last modified on
2018 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032250

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.