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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039444
Receipt No. R000043559
Scientific Title Phase I dose-escalation study of stereotactic body radiation therapy for prostate cancer
Date of disclosure of the study information 2020/02/10
Last modified on 2020/02/10

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Basic information
Public title Phase I dose-escalation study of stereotactic body radiation therapy for prostate cancer
Acronym Phase I dose-escalation study of stereotactic body radiation therapy for prostate cancer
Scientific Title Phase I dose-escalation study of stereotactic body radiation therapy for prostate cancer
Scientific Title:Acronym Phase I dose-escalation study of stereotactic body radiation therapy for prostate cancer
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to evaluate the maximum tolerated dose of stereotactic body radiation therapy for localized prostate cancer with or without injection of hydrogel spacer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes The incidence of CTCAE grade 3-5 toxicity during the initiation of radiotherapy and 180 days from the end of radiotherapy.
Toxicities will be graded using CTCAE version 5.0.
Key secondary outcomes The incidence of toxicity during the initiation of radiotherapy and 90 days from the end of radiotherapy
The incidence of toxicity during the follow-up period after 91 days from the end of radiotherapy
The incidence of toxicity caused by injection of hydrogel spacer
The incidence of patient-reported toxicity based on PRO-CTCAE version 1.0
Quality of life using EPIC and FACT-P
The International Prostate Symptom Score (IPSS)
Overall survival
biochemical recurrence-free survival using the Phoenix definition of biochemical failure

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
Other
Interventions/Control_1 Patients received five-fraction stereotactic body radiation therapy (SBRT) every other day in weekdays. Total dose was 42.5 Gy, 45 Gy, or 47.5 Gy using 6+6 design. Dose-escalation was independently performed among each of the patients who received SBRT with hydrogel spacer and those who received SBRT without 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
85 years-old >=
Gender Male
Key inclusion criteria a) Pathologically proven prostate cancer
b) ECOG performance status of 0-2
c) Aged 20 to 85 years old at the time of informed consent
d) Written informed consent
Key exclusion criteria a) Refusal to participate
b) Lymph node or distant metastasis
c) History of treatment except hormone therapy for prostate cancer
d) History of radiotherapy for pelvic region
e) Inflammatory bowel disease like ulcerative colitis and Crohn's disease
f) History of surgery for rectal disease
g) Participants of other clinical trial that may affect the result of this study
h) Ineligible patients judged by investigators

Following patients were ineligible for injection of hydrogel spacer
i) Difficult to insert the ultrasound probe into the rectum
j) Allergic to local anesthetic agents
k) Rectum invasion or dorsal extracapsular invasion
Target sample size 72

Research contact person
Name of lead principal investigator
1st name Hideomi
Middle name
Last name Yamashita
Organization The University of Tokyo Hospital
Division name Radiology
Zip code 113-8655
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Email yamachan07291973@yahoo.co.jp

Public contact
Name of contact person
1st name Hideomi
Middle name
Last name Yamashita
Organization The University of Tokyo Hospital
Division name Radiology
Zip code 113-8655
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Homepage URL
Email yamachan07291973@yahoo.co.jp

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 10 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 Enrolling by invitation
Date of protocol fixation
2020 Year 01 Month 15 Day
Date of IRB
2020 Year 01 Month 22 Day
Anticipated trial start date
2020 Year 02 Month 10 Day
Last follow-up date
2026 Year 12 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
2020 Year 02 Month 10 Day
Last modified on
2020 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043559

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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