UMIN-CTR Clinical Trial

Basic information
Public title	Biochemistry-like based on the prostate-specific antigen (Prostate specific antigen: PSA) change by which recurrence relief is receiving radiation treatment after a prostatic cancer operation, adaptation will receive radiation treatment immediately.
Acronym	Prostate relief
Scientific Title	Biochemistry-like based on the prostate-specific antigen (Prostate specific antigen: PSA) change by which recurrence relief is receiving radiation treatment after a prostatic cancer operation, adaptation will receive radiation treatment immediately.
Scientific Title:Acronym	Prostate relief
Region	Japan

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

Objectives
Narrative objectives1	When the most suitable relief radiation treatment from which surplus treatment was put aside can be achieved, it's hypothesized to do pelvis lymph node prevention irradiation about PSA fuourei which is being treated in PBRT, and safety and the validity are estimated.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	5th year, Biochemistry-like non-recurrence survival rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Treatment measures PSA before treatment and makes PBRT precedent first. PSA is checked in the time 46 Gy applied, and when it's in the standard value calculated based on PSA before treatment, PBRT is continued and irradiation is ended by 68 Gy. When exceeding the standard value, PBRT begins PWRT, and makes PWRT irradiation to 50 Gy to 68 Gy. Treatment lead period 1~14 days Radiation treatment period 2~3 months Post-observation period 60 months
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	85 years-old >
Gender	Male
Key inclusion criteria	1 cT1~3bN0~1M0,Total prostatectomy,Biochemical recurrence 2 Adenocarcinoma or Tubular adenocarcinoma 3 Performance status0-1
Key exclusion criteria	1.Chemotherapy has received the whole body method of treatment including hormone treatment. 2.There is radiation treatment in the pelvis in the past. 3.Active overlap cancer
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Toshiki Middle name Last name Ohno
Organization	Kamagaya General Hospital
Division name	Radiation therapy
Zip code	273-0121
Address	929-6 Hatsutomi, Kamagaya-City Chiba
TEL	047-498-8111
Email	chiken@kamagaya-hp.jp

Public contact
Name of contact person	1st name Toshiki Middle name Last name Ohno
Organization	Kamagaya General Hospital
Division name	Radiation therapy
Zip code	273-0121
Address	929-6 Hatsutomi, Kamagaya-City Chiba
TEL	047-498-8111
Homepage URL
Email	chiken@kamagaya-hp.jp

Sponsor
Institute	Kamagaya General Hospital
Institute
Department

Funding Source
Organization	Kamagaya General Hospital
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	The TOKUSHUKAI GROUP ETHICS COMMITTEE
Address	Emina Building 3F,1-8-7 Koji-machi,Chiyoda-ku,Tokyo
Tel	03-3263-4801
Email	mirai-ec4@mirai-iryo.com

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	2022 Year 05 Month 20 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	Open public recruiting
Date of protocol fixation	2022 Year 03 Month 01 Day
Date of IRB	2022 Year 05 Month 17 Day
Anticipated trial start date	2022 Year 05 Month 17 Day
Last follow-up date	2029 Year 07 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	2022 Year 04 Month 20 Day
Last modified on	2022 Year 06 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054210

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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