UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026213 |
|---|---|
| Receipt number | 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 | 2021/08/23 10:26:38 |
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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
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
ogitam-rad@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Partially published
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
Main results already published
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
| 2021 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029385
