Prostate cancer
Conditions
Interventions
None listed
Sponsors
Kagawa university
Eligibility
Sex/Gender
Male
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Actice surveillance remaining rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical progression rate Evidenced by metastasis Disease specific survival QOL | — |
Countries
Japan,Europe
Contacts
Public ContactMikio Sugimoto
Kagawa university Department of Urology
Outcome results
None listed