UMIN-CTR Clinical Trial

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