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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047536
Receipt No. R000054210
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.
Date of disclosure of the study information 2022/05/20
Last modified on 2022/06/13

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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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