Criteria for inclusion in PRIAS:
1) Histologically proven adenocarcinoma of the prostate.
2) Men should be fit for curative treatment.
3) PSA-level at diagnosis ≤ 10 ng/mL.
4) PSA density (PSA D) less than 0.2.
5) Clinical stage T1C or T2.
6) Gleason score 3+3=6.
7) One or 2 biopsy cores invaded with prostate cancer:
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).
If saturation biopsies (either transperineal or transrectal) are done 15% of the cores can be positive with a maximum of 4. (i.e. <20 cores 2 cores can be positive (standard), 20-26 cores 3 cores can be positive, >26 cores 4 cores can be positive) (all other inclusion criteria still apply).
8) Participants must be willing to attend the follow-up visits.
Note: Patients with biopsy Gleason score 3+4 can be followed outside the actual PRIAS protocol.
The patient should be at least 70 years old and should have evidence of limited disease (maximum 10% tumor involvement per biopsy core, maximum 2 cores positive).
Risk reclassification is defined as any upgrading in Gleason score and/or more than 2 positive cores at repeat biopsy.
1) Men who can not or do not want to be radiated or operated.
2) A former therapy for prostate cancer.