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ID
Source
Brief title
Health condition
Prostate cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
- For different biopsy strategies, the accuracy of the Gleason score (GS) of (MRDB) biopsies in predicting the definite GS at whole mount radical prostatectomy specimens.
- A cost-effectiveness assessment to analyze the different biopsy strategies.
- The histopathological results of biopsies in relation to mpMRI assessment.
- The value of the (MRI-based) risk calculator (e.g. ERSPC-RC3).
- The role of multidisciplinary team meetings in clinical shared-decision making.
- How to manage equivocal (PI-RADS 3) lesions.
- A comparison of targeted biopsy methods (MR-in bore, MR-TRUS fusion and MR-cognitive biopsies) and the additional value of systematic biopsy.
Background summary
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.
Study objective
Men without a suspicious prostate MRI (i.e. PI-RADS 1-2) can safely avoid (systematic) biopsy.
Study design
Time of inclusion: 24 months
Time of follow-up: 36 months (interim analysis after 12 and 24 months).
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8331 |
| Other | METC Radboudumc : CMO 2019-5191 |