UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035990
Receipt number R000040993
Scientific Title Practice in the Radiation Therapy for Stage D1 Prostate Cancer: Survey of the Japanese Radiation Oncology Study Group (JROSG)
Date of disclosure of the study information 2019/02/24
Last modified on 2022/02/26 14:50:59

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Basic information

Public title

Practice in the Radiation Therapy for Stage D1 Prostate Cancer: Survey of the Japanese Radiation Oncology Study Group (JROSG)

Acronym

D1 prostate

Scientific Title

Practice in the Radiation Therapy for Stage D1 Prostate Cancer: Survey of the Japanese Radiation Oncology Study Group (JROSG)

Scientific Title:Acronym

D1 prostate

Region

Japan


Condition

Condition

Radiation therapy for stage D1 prostate cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To retrospectively analyze the clinical outcomes of radiation therapy for stage D1 prostate cancer in Japan.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall Survical

Key secondary outcomes

Progression-free survival, disease-free survival, adverse events rate


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


Not applicable

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

Radiation therapy for stage D1 prostate cancer

Key exclusion criteria

There is no pathological diagnosis
Patients undergoing surgery for prostate cancer

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Toshiya
Middle name
Last name Maebayashi

Organization

Nihon University school of medicine

Division name

Radiology

Zip code

173-8610

Address

Itabashi-ku

TEL

0339728111

Email

maebayashi.toshiya@nihon-u.ac.jp


Public contact

Name of contact person

1st name Toshiya
Middle name
Last name Maebayashi

Organization

Nihon University school of medicine

Division name

Radiology

Zip code

173-8610

Address

Itabashi-ku

TEL

0339728111

Homepage URL


Email

maebayashi.toshiya@nihon-u.ac.jp


Sponsor or person

Institute

Nihon University school of medicine

Institute

Department

Personal name



Funding Source

Organization

Nihon University school of medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nihon University School of Medicine

Address

30-1 Oyaguchi Kami-cho Itabashi-ku

Tel

0339728111

Email

maebayashi.toshiya@nihon-u.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

日本大学医学部附属板橋病院


Other administrative information

Date of disclosure of the study information

2019 Year 02 Month 24 Day


Related information

URL releasing protocol

https://jrosg.jp/%E3%83%97%E3%83%AD%E3%83%88%E3%82%B3%E3%83%BC%E3%83%AB/%E3%83%97%E3%83%AD%E3%83%88%

Publication of results

Partially published


Result

URL related to results and publications

2020 Annual Meeting American Society for Radiation Oncology (ASTRO)

Number of participants that the trial has enrolled

169

Results

The median follow-up period was 53 months (range, 9-99). Estimated 5-year overall and progression free survival rates were 84.6% and 69.3%, respectively.
Fifty-one (30.2%) patients developed biochemical recurrence.Multivariate analyses indicated that BED was the only significant prognostic factor for overall survival (p=0.01) and DSS (p=0.04).

Results date posted

2021 Year 08 Month 27 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Clinical records of 169 patients with cT1-4N1M0 prostate cancer treated with definitive radiotherapy between 2011 and 2015

Participant flow

Clinical records of 169 patients with cT1-4N1M0 prostate cancer treated with definitive radiotherapy between 2011 and 2015

Adverse events

Regarding late adverse events, 12 (7.1%) and 11 (6.5%) patients experienced grade 2 or higher gastrointestinal and genitourinary toxicities, respectively.

Outcome measures

Multivariate analyses indicated that BED was the only significant prognostic factor for overall survival (p=0.01) and DSS (p=0.04)

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2019 Year 02 Month 13 Day

Date of IRB

2019 Year 01 Month 11 Day

Anticipated trial start date

2011 Year 01 Month 01 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry

2022 Year 02 Month 26 Day

Date trial data considered complete

2022 Year 09 Month 01 Day

Date analysis concluded

2023 Year 09 Month 01 Day


Other

Other related information

None


Management information

Registered date

2019 Year 02 Month 24 Day

Last modified on

2022 Year 02 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040993


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name