Men without a suspicious prostate MRI (i.e. PI-RADS 1-2) can safely avoid (systematic) biopsy.
ID
Bron
Verkorte titel
Aandoening
Prostate cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The follow-up of men in different mpMRI-‘first’ pathways with regard to detection rates of indolent- and csPCa and prostate biopsy rates during a follow-up period of three years.
Achtergrond van het onderzoek
Prostate cancer (PCa) is one of the most commonly diagnosed malignancy in men. The limited diagnostic accuracy of systematic transrectal ultrasound guided biopsies (TRUSGB) raised an emerging interest in the diagnostic value of multiparametric magnetic resonance imaging (mpMRI). Recent studies have shown the superiority and feasibility of an mpMRI-‘first’ pathway with upfront mp-MRI in biopsy-naïve men suspected with prostate cancer. This diagnostic approach can accurately detect clinically significant prostate cancer (csPCa) while minimizing the amount biopsies and over-detection of indolent PCa, by only performing a prostate biopsy in case of suspicious mpMRI. However, this is at the risk of under-detecting csPCa. Negative predictive values are reported to be high, but mid-long-term outcomes in clinical practice have not yet been described. Furthermore, the diagnostic follow-up of men in case of high suspicion for csPCa at mpMRI with benign biopsy results is still unclear. This multi-center observational study will investigate mpMRI-‘first’ diagnostic pathways in biopsy-naïve men with suspected prostate cancer, including follow-up.
Doel van het onderzoek
Men without a suspicious prostate MRI (i.e. PI-RADS 1-2) can safely avoid (systematic) biopsy.
Onderzoeksopzet
Time of inclusion: 24 months
Time of follow-up: 36 months (interim analysis after 12 and 24 months).
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Biopsy-naïve men, aged 18-80 years.
- Clinical suspicion of prostate cancer (i.e. PSA ≥ 3.0 ng/ml and/or abnormal DRE).
- Men must be able to comprehend and sign an informed consent and must be able to comprehend and sign an MRI screening form (to search for metal device/foreign bodies/claustrophobia).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- History of previous prostate biopsy.
- Already proven prostate cancer or history of PCa.
- Contraindications for an MRI scan (with gadolinium contrast).
- History of invasive treatments for BPH or lower urinary tract symptoms (LUTS), e.g. transurethral
resection of the prostate; heat, laser or ultrasound treatments in the last 12 months.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8331 |
| Ander register | METC Radboudumc : CMO 2019-5191 |