UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational safety and efficacy study of the carbon ion radiotherapy in 16 fractions for localized prostate cancer
Acronym	GUNMA1302
Scientific Title	Prospective observational safety and efficacy study of the carbon ion radiotherapy in 16 fractions for localized prostate cancer
Scientific Title:Acronym	GUNMA1302
Region	Japan

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

Objectives
Narrative objectives1	To confirm the safety and efficacy of the carbon ion radiotherapy in 16 fractions for T1c-T3N0M0 prostate cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	5-yr biochemical relapse free survival
Key secondary outcomes	1) 5-yr overall survival 2) 5-yr cause specific survival 3) 5-yr local control 4) acute toxicity 5) late toxicity 6) QOL

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	1) Histologically proven primary prostate adenocarcinoma 2) Gleason score is diagnosed 3) T1c-T3N0M0(2009, UICC 7th) 4) PSA value before biopsy is measured 5) Age at registration is 20-80 6) Performance status is 0-2 7) Diagnosis is informed 8) Having the ability to consent
Key exclusion criteria	1) Past radiotherapy to the pelvic region 2) Past physical treatment of the prostate (TUR-P, HIFU, etc.) 3) Past chemotherapy within 4 weeks 4) Life expectancy is less than 6 months 5) Multiple malignancies within 5 years 6) Androgen deprivation therapy period will be over than 8 months at the end of carbon ion radiotherapy 7) Castration refractory 8) Denial for the protocol androgen deprivation therapy 9) Steroid and anti-androgen therapy for other disease 10) Severe comorbidity 11) Judged inappropriate for this study by physicians
Target sample size	280

Research contact person
Name of lead principal investigator	1st name Kazuhiro Middle name Last name Suzuki
Organization	Gunma University
Division name	Urology
Zip code	371-8511
Address	3-39-22 Showa-machi, Maebashi
TEL	(027)220-8300
Email	kazu@gunma-u.ac.jp

Public contact
Name of contact person	1st name Hidemasa Middle name Last name Kawamura
Organization	Gunma University
Division name	Heavy ion medical center
Zip code	371-8511
Address	3-39-22 Showa-machi, Maebashi
TEL	027-220-8378
Homepage URL
Email	kawa@gunma-u.ac.jp

Sponsor
Institute	working group of heavy ion therapy for genitourinary tumor, Gunma university
Institute
Department

Funding Source
Organization	Gunma University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Gunma University Hospital IRB
Address	3-39-22 Showa-machi, Maebashi
Tel	027-220-8740
Email	gunmaciru-office@umin.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	2015 Year 03 Month 01 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	Completed
Date of protocol fixation	2013 Year 06 Month 10 Day
Date of IRB	2013 Year 06 Month 27 Day
Anticipated trial start date	2013 Year 07 Month 01 Day
Last follow-up date	2020 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Check the symptoms, laboratory tests, radiological tests and QOL scores periodically.

Management information
Registered date	2015 Year 02 Month 26 Day
Last modified on	2022 Year 03 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019300