UMIN-CTR Clinical Trial

Basic information
Public title	Active surveillance for favorable and intermediate risk prostate cancer (PRIAS-JAPAN)
Acronym	Active surveillance for prostate cancer (PRIAS-JAPAN)
Scientific Title	Active surveillance for favorable and intermediate risk prostate cancer (PRIAS-JAPAN)
Scientific Title:Acronym	Active surveillance for prostate cancer (PRIAS-JAPAN)
Region	Japan

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

Objectives
Narrative objectives1	To validate the inclusion criteria and follow-up protocol of active surveillance
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	metastasis-free survival
Key secondary outcomes	cancer-specific survival, the rate of reclassification, continuation rate of active surveillance, Quality Of Life(QOL)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	active surveillance
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	1)Histologically proven adenocarcinoma of the prostate. 2)Men should be fit for curative treatment. 3) PSA level at diagnosis 10 ng/mL or less, or 20 ng/mL or less if MRI is used at diagnosis or during follow up 4) PSA density (PSA D) less than 0.2, or if MRI is used and negative or if targeted biopsies show no more than Gleason score 3+3 or 3+4 without invasive cribriform and intraductal carcinoma (CR/IDC) PSA D of less than 0.25 is acceptable. Patients with a PSA D more than 0.25 at inclusion can be followed outside the actual PRIAS protocol. 5) Clinical stage T1C or T2. 6) Gleason score 3+3=6 or Gleason score 3+4 without invasive CR/IDC. Total number of positive cores allowed: a. If an MRI, including targeted biopsies on positive lesions, is done at inclusion, there is no limit in the number of positive cores (that is, more than two, and no limit in the % of cancer present in the cores). b. If saturation biopsies (either transperineal or transrectal) are done 15% of the cores can be positive with a maximum of 4. (i.e. less than 20 cores: 2 cores can be positive (standard), 20-26 cores: 3 cores can be positive, more than 26 cores: 4 cores can be positive) (all other inclusion criteria still apply). c. If more than 2 TRUS-guided biopsy cores are positive (Gleason score 3+3 or 3+4 without CR/IDC) an MRI is indicated. If the MRI is negative or if targeted biopsies show no more than Gleason score 3+3=6 or 3+4=7 without invasive CR/IDC, inclusion is possible. d. For patients with adenocarcinoma Gleason score 3+4 without invasive CR/IDC, the maximum number of positive cores should be less than 50%, where multiple positive cores from the same lesion on MRI count for one positive core. 7) Participants must be willing to attend the follow-up visits. 8) Signed informed consent
Key exclusion criteria	1) Men who can not or do not want to be radiated or operated. 2) A former therapy for prostate cancer. 3) For patients with a life expectancy <10yrs
Target sample size	1900

Research contact person
Name of lead principal investigator	1st name Mikio Middle name Last name Sugimoto
Organization	Kagawa University
Division name	Department of Urology
Zip code	761-0793
Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL	0878985111
Email	sugimoto.mikio@kagawa-u.ac.jp

Public contact
Name of contact person	1st name Takuma Middle name Last name Kato
Organization	Kagawa University
Division name	Department of Urology
Zip code	761-0793
Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL	0878985111
Homepage URL
Email	kato.takuma@kagawa-u.ac.jp

Sponsor
Institute	Kagawa University
Institute
Department

Funding Source
Organization	Kagawa University
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	Kagawa University
Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
Tel	0878985111
Email	uro-m@kagawa-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

Other administrative information
Date of disclosure of the study information	2022 Year 06 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	Enrolling by invitation
Date of protocol fixation	2022 Year 03 Month 31 Day
Date of IRB	2022 Year 03 Month 31 Day
Anticipated trial start date	2022 Year 03 Month 31 Day
Last follow-up date	2042 Year 09 Month 30 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 06 Month 18 Day
Last modified on	2022 Year 06 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054817

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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