Unique ID issued by UMIN | UMIN000002874 |
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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 |
Active surveillance for early prostate cancer: international study (PRIAS-JAPAN)
PRIAS-JAPAN
Active surveillance for early prostate cancer: international study (PRIAS-JAPAN)
PRIAS-JAPAN
Japan | Europe |
Prostate cancer
Urology |
Malignancy
NO
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.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Actice surveillance remaining rate
Clinical progression rate
Evidenced by metastasis
Disease specific survival
QOL
Observational
Not applicable |
Not applicable |
Male
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.
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.
1400
1st name | |
Middle name | |
Last name | Yoshiyuki Kakehi |
Kagawa university
Department of Urology
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa pref. 761-0793
+81-87-891-2202
kakehi@med.kagawa-u.ac.jp
1st name | |
Middle name | |
Last name | Mikio Sugimoto |
Kagawa university
Department of Urology
Kagawa pref.
+81-87-891-2202
micsugi@med.kagawa-u.ac.jp
Kagawa university
Kagawa university
Other
NO
香川大学医学部附属病院(香川県)
2009 | Year | 12 | Month | 11 | Day |
Unpublished
Enrolling by invitation
2009 | Year | 10 | Month | 06 | Day |
2010 | Year | 01 | Month | 01 | Day |
We are registrating participation institutes.
2009 | Year | 12 | Month | 11 | Day |
2021 | Year | 01 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003506
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