UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016646
Receipt number R000019300
Scientific Title Prospective observational safety and efficacy study of the carbon ion radiotherapy in 16 fractions for localized prostate cancer
Date of disclosure of the study information 2015/03/01
Last modified on 2022/03/03 10:07:48

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019300


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name