UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039444 |
|---|---|
| Receipt number | 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 13:17:21 |
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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
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
yamachan07291973@yahoo.co.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043559
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