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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038279
Receipt No. R000043633
Scientific Title Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer
Date of disclosure of the study information 2020/01/06
Last modified on 2019/10/11

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Basic information
Public title Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer
Acronym Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer
Scientific Title Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer
Scientific Title:Acronym Phase I/II clinical trial of hypofractionated image-guided proton therapy for prostate cancer
Region
Japan

Condition
Condition localized prostate cancer
Classification by specialty
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of hypofractionated image-guided proton therapy for prostate cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The ratio of grade 2 or more acute genitourinary toxicity
Key secondary outcomes 5-year OS, bRFS, cRFS, bRF, cRF, Grade 2 or more late toxicity, QOL change

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
Other
Interventions/Control_1 image-guided proton therapy
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) histologically-confirmed prostate cancer
2) T1-T3bN0M0
3) ECOG-PS: 0-2
4) age: more than 20 years old
5) serious underlying disease or other cancers
6) capable of maintaining their position during irradiation
7) technically capable of proton therapy
8) written informed consent
Key exclusion criteria 1)pathological specimen is not available to confirm the diagnosis
2)previous radiotherapy around the lesion
3)surgery for prostate cancer is performed prior to registration
4)active and uncontrolled infection
5)two or more anticoagulants and antiplatelets
6)bowel disease such as ulcerative colitis or postoperative rectal cancer
7)patients who cannot or refuse gold markers and Space OAR
8)serious complication
9)cases in which the doctor is judged inappropriate for medical or other reasons
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Ogino
Organization Nagoya City West Medical Center,Nagoya Proton Therapy Center
Division name Radiation oncology
Zip code 462-8508
Address 1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture
TEL 052-991-8577
Email oginogio@gmail.com

Public contact
Name of contact person
1st name Hiromitsu
Middle name
Last name Iwata
Organization Nagoya City West Medical Center,Nagoya Proton Therapy Center
Division name Radiation oncology
Zip code 462-8508
Address 1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture
TEL 052-991-8577
Homepage URL
Email h-iwa-ncu@nifty.com

Sponsor
Institute Nagoya City West Medical Center
Institute
Department

Funding Source
Organization Takeda Science Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Clinical Study Committees of the Nagoya City Hospital
Address 1-2-23 Wakamizu, Chikusa-ku, Nagoya-city, Aichi-prefecture
Tel 052-721-7171
Email rinsho1@higashi-hosp.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 01 Month 06 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 Preinitiation
Date of protocol fixation
2019 Year 08 Month 07 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 06 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
2019 Year 10 Month 11 Day
Last modified on
2019 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043633

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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