UMIN-CTR Clinical Trial

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
Institute	Nihon University school of medicine
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040993