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 UMIN000014671
Receipt No. R000016877
Scientific Title Phase II study of hypofractionated stereotactic body radiation therapy for prostate cancer
Date of disclosure of the study information 2014/07/28
Last modified on 2014/07/28

* 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 Phase II study of hypofractionated stereotactic body radiation therapy for prostate cancer
Acronym Phase II study of hypofractionated stereotactic body radiation therapy for prostate cancer
Scientific Title Phase II study of hypofractionated stereotactic body radiation therapy for prostate cancer
Scientific Title:Acronym Phase II study of hypofractionated stereotactic body radiation therapy for prostate cancer
Region
Japan

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

Objectives
Narrative objectives1 The aim is to determine the efficacy of hypofractionated stereotactic body radiation therapy for localized prostate cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the incidence of delayed adverse events at 5 years
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
Interventions/Control_1 irradiation
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
50 years-old <=
Age-upper limit
80 years-old >
Gender Male
Key inclusion criteria 1)adenocaricnoma of the prostate which was pathologically confirmed
2) low risk group or intermediate risk group (T1-T2c and PSA =<20 ng/mL and Gleason score =<7)
3)neoadjuvant hormonal therapy for 3-12 months has been undertaken in patients with intermediate risk group
4)age:>=50,<80 years
5)Performance status:0-1
6)gold markers have been inserted
7)informed consent has been obtained
Key exclusion criteria 1)Patients who have had any other cancer within the past 5 years
2)Patients who have uncontrollable diabetes mellitus
3)Patients who have serious comorbidities such as collagen disease, heart disease, interstitial pneumonia, liver cirrhosis
4)patients who have a psychological problem
5)patients who had previously received pelvic irradiation
6)patients who had previously received pelvic surgery
7)patients who had previously received TURP, orchiectomy, or HIFU
8)patients who had previously received chemotherapy for prostate cancer
9)patients who have Crohn's disease or ulcerative colitis
10)patients who require concomitant anticoagulant therapy
11)IPSS at registration>=20
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Akitomo Sugawara
Organization Tokai University Hachioji Hospital
Division name Radiation Oncology
Zip code
Address 1838 Ishikawa-machi, Hachioji, Tokyo
TEL 042-639-1111
Email h4411@wave.plala.or.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Akitomo Sugawara
Organization Tokai University Hachioji Hospital
Division name Radiation Oncology
Zip code
Address 1838 Ishikawa-machi, Hachioji, Tokyo
TEL 042-639-1111
Homepage URL
Email h4411@wave.plala.or.jp

Sponsor
Institute Radiation Oncology, Tokai University Hachioji Hospital
Institute
Department

Funding Source
Organization N/A
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
2014 Year 07 Month 28 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
2014 Year 05 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 29 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 07 Month 28 Day
Last modified on
2014 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016877

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.