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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026213
Receipt No. R000029385
Scientific Title Phase II trial of stereotactic body radiotherapy with a hydrogel spacer for prostate cancer
Date of disclosure of the study information 2017/02/20
Last modified on 2019/08/23

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Basic information
Public title Phase II trial of stereotactic body radiotherapy with a hydrogel spacer for prostate cancer
Acronym Prostate stereotactic body radiotherapy with a hydrogel spacer
Scientific Title Phase II trial of stereotactic body radiotherapy with a hydrogel spacer for prostate cancer
Scientific Title:Acronym Prostate stereotactic body radiotherapy with a hydrogel spacer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety and efficacy of stereotactic body radiotherapy (SBRT) with the use of hydrogel spacer for prostate cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes All acute gastrointestinal toxicity
Key secondary outcomes Dose Volume Histogram
Adverse events related to spacer insertion
Success rate of spacer insertion
Position of the spacer at the last day of radiotherapy
Acute genitourinary toxicity
Late gastrointestinal and genitourinary toxicity
Other toxicities related to radiotherapy
QOL:Expanded Prostate Cancer Index Composite (EPIC) and Functional Assessment of Cancer Therapy Prostate (FACT P)
The International Prostate Symptom Score (IPSS)
Biochemical failure free survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Insertion of the hydrogel spacer
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 Prostate cancer patients
Pathologically diagnosed adenocarcinoma
Age >= 20 years, <= 80 years
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade 0-2
Number of prostate core needle biopsies >= 8
Patients must provide written, informed consent before any study procedures occur
Key exclusion criteria Patients with lymph node metastasis and or distant metastasis
History of prostate cancer treatment (surgery, high intensity focused ultrasound, chemotherapy)
Hormone therapy >= 12 months before radiotherapy
History of pelvic radiotherapy
History of any other malignancy within 2 years (except carcinoma in situ)
Severe cardiovascular disease
Severe respiratory disease
Liver disease (AST, ALT >20 x ULN)
Severe kidney disease requiring hemodialysis
Unable to provide written informed consent
Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
History of lowerpelvic surgery
Metal in pelvic or near pelvic area (e.g. total hip replacement) affecting pelvic CT scan
Bleeding tendency that may disrupt hydrogel spacer insertion (Plt <= 100000, PT INR > 1.5 ULN (with anticoagulant, PT INR > 2.5 ULN), APTT >= 2 x ULN)
Unable to insert ultrasound probe (e.g. anal stenosis)
Allergic to local anesthetics
Considered not appropriate for the study by investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Mami
Middle name
Last name Ogita
Organization The University of Tokyo Hospital
Division name Radiology
Zip code Mami
Address 7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL 08031373772
Email ogitam-rad@h.u-tokyo.ac.jp

Public contact
Name of contact person
1st name Mami
Middle name
Last name Ogita
Organization The University of Tokyo Hospital
Division name Radiology
Zip code 1138655
Address 7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL 03-3815-5411
Homepage URL
Email ogitam-rad@h.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address 7-3-1 Hongo Bunkyo-ku Tokyo Japan
Tel 03-5841-0818
Email ethics@m.u-tokyo.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 東京大学医学部附属病院/The University of Tokyo Hospital

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 20 Day

Related information
URL releasing protocol http://www.u-tokyo-rad.jp/index.html
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 42
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
2017 Year 02 Month 08 Day
Date of IRB
2017 Year 02 Month 08 Day
Anticipated trial start date
2017 Year 02 Month 20 Day
Last follow-up date
2021 Year 09 Month 01 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 02 Month 19 Day
Last modified on
2019 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029385

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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