UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002874
Receipt number R000003506
Scientific Title Active surveillance for early prostate cancer: international study (PRIAS-JAPAN)
Date of disclosure of the study information 2009/12/11
Last modified on 2021/01/31 16:50:15

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Basic information

Public title

Active surveillance for early prostate cancer: international study (PRIAS-JAPAN)

Acronym

PRIAS-JAPAN

Scientific Title

Active surveillance for early prostate cancer: international study (PRIAS-JAPAN)

Scientific Title:Acronym

PRIAS-JAPAN

Region

Japan Europe


Condition

Condition

Prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective of this research project is to study differences between men who elect immediate treatment and those who elect to postpone treatment for their prostate cancer. This will be measured by means of the need for treatment, spread of the cancer, death from prostate cancer and quality of life in Japanese patients. Also to validate the inclusion criteria and the follow-up protocol, and to compare the outcomes between races.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Actice surveillance remaining rate

Key secondary outcomes

Clinical progression rate
Evidenced by metastasis
Disease specific survival
QOL


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

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 or higher 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 50% or less, 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 of <10yr, watchful waiting is preferred above Active Surveillance.

Target sample size

1400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiyuki Kakehi

Organization

Kagawa university

Division name

Department of Urology

Zip code


Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa pref. 761-0793

TEL

+81-87-891-2202

Email

kakehi@med.kagawa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mikio Sugimoto

Organization

Kagawa university

Division name

Department of Urology

Zip code


Address

Kagawa pref.

TEL

+81-87-891-2202

Homepage URL


Email

micsugi@med.kagawa-u.ac.jp


Sponsor or person

Institute

Kagawa university

Institute

Department

Personal name



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


Address


Tel


Email



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

香川大学医学部附属病院(香川県)


Other administrative information

Date of disclosure of the study information

2009 Year 12 Month 11 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

2009 Year 10 Month 06 Day

Date of IRB


Anticipated trial start date

2010 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We are registrating participation institutes.


Management information

Registered date

2009 Year 12 Month 11 Day

Last modified on

2021 Year 01 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003506


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name