Met prostaat MRI Meer Mans

Rationale: Prostate cancer is the most common malignancy in men in the Netherlands. In 2009, 10,166 new cases were seen with a mortality of 2,492. With an increasing incidence, a growing economic burden presses the community. Furthermore, PSA testing is not specific and subsequent transrectal ultrasound (TRUS) biopsy result in over-diagnosis, and subsequent overtreatment. The disadvantages of PSA have led to the development of multivariate risk prediction tools, for example the Prostate Cancer Risk Calculator based on ERSPC data and the discovery of PCa-specific biomarkers that have a higher specificity for detecting significant prostate cancer and can preferably be obtained through non-invasive methods, for example Quattro urine test,[referentie] It has been shown that MRI and MRI-guided biopsy are accurate in localizing aggressive cancer in selected patient populations. We expect that MRI may also be of additional value in the population of men with an elevated PSA in selectively detecting significant cancers. If so, it will result in a more accurate therapy choice –specifically reduction of overdiagnosis and thus overtreatment– and reduced number of biopsies, with subsequent lower morbidity and lower costs. However, empirical evidence in this population is lacking.
Objective: To investigate the additional value of MRI and MRI-guided biopsy in men with an elevated PSA upon first visit to the urologist regarding the detection of both insignificant and significant cancer, and the reduction of biopsy numbers. Combined with evaluation of the added value of the prostate risk calculator and Quattro urine test in predicting significant PCa.


Study design: Clinical trial with a follow-up of 24 months.
Study population: Men aged 50-75 years who visit the urologist after PSA screening and have a subsequent PSA ≥ 3 ng/ml.


Intervention (if applicable): Men with an elevated PSA will undergo standard DRE and donate urine for Quattro biomarker analysis, subsequently an MRI and MRI-guided biopsies of MR-suspicious lesions are performed followed by the usually performed random TRUS-guided biopsies.
Main study parameters/endpoints: Primary endpoint: clinical insignificant versus significant cancers detected. Secondary endpoints: health-related quality of life, accuracy of MR-guided biopsies, cost-effectiveness, number of biopsies taken per patient, the added value of the prostate risk calculator and Quattro urine test, defining a cut-off point to undergo prostate biopsies for PSA values above 3 ng/ml.
To study the primary endpoint, the following analyses will be performed: comparison of the pathology outcomes of TRUS- and MR-guided biopsies within the patient group who underwent both biopsies, and comparison of the pathology outcomes of all performed TRUS-guided biopsies and MR-guided biopsies.


Nature and extent of the burden and risks associated with participation, benefit and group relatedness: MR imaging may cause some discomfort, such as feelings of claustrophobia and discomfort due to loud sounds of the MR instrument during the study. Patients are screened for prior claustrophobic symptoms using a screening form, which is also used to search for metal device and foreign bodies. Around 330 patients also undergo MR-biopsies (2 to 3 needles), which causes inconvenience and takes more time. The donation of urine for the Quattro urine test does not cause any additional risk and the burden of providing a urine sample is considered to be minimal.

We expect that mp-MRI, molecular urine test and Prostate Cancer Risk Calculator may be of additional value in differentiating between significant and insignificant cancers in men with an elevated PSA in the primairy diagnosis. If so, it will result in a better and more accurate diagnosis while needing less biopsy cores, resulting in a more accurate therapy choice with subsequent lower morbidity, an increased quality of life and at lower costs. However, empirical evidence in men with increased PSA is lacking.

T1: Inventation to participate in trial, Questionnaire set, urine test, prostate risc calculator

T2: MRI scan performed, Questionnaire set, MRI guided biopsy if suspicious lesion is detected.

T3: TRUS guided biopsy, Questionnaire set

T4: Questionnaire set

T5: Questionnaire set

T6: Questionnaire set

Men with an elevated PSA will undergo standard DRE and donate urine for urine biomarker analysis, subsequently an MRI and MRI-guided biopsies of MR-suspicious lesions are performed followed by the usually performed random TRUS-guided biopsies.