Prostate cancer, overdiagnosis, overtreatment, active surveillance
Conditions
Interventions
Sponsors
Erasmus MC, Rotterdam.
Eligibility
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. 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: 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. 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.
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Prostate cancer specific and overall mortality. | — |
Contacts
Public ContactMonique Roobol-Bouts
Erasmus Medical Center, Department of Urology, P.O. Box 2040
Outcome results
None listed