Prostate cancer, molecular urine test, mri prostate, mri guided biopsy, prostate risc calculator, PSA, TRUS biopsy Dutch: Prostaatkanker, moleculaire biomarker, prostaat risico calculator, MRI, MRI geleide biopsie, echo gelede transrectale biopsie, PSA
Conditions
Interventions
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 usu
Sponsors
Radboudumc
Eligibility
Inclusion criteria
Inclusion criteria: • Men aged 50-75 years • PSA ≥ 3.0 ng/ml • Subject must be able to comprehend and sign an informed consent by patient • Subject must be able to comprehend and sign an MRI screening form (to search for metal device/foreign bodies/claustrophobia) • No contraindications for and are eligible to have a MR scan of their prostate utilizing a surface coil
Exclusion criteria
Exclusion criteria: • Impossibility to obtain a valid informed consent • History of previous prostate biopsy • Already proven prostate cancer or history of PCa. Patients unable to undergo MR imaging, including those with contra-indications • Allergic reaction to gadolinium in the past or eGFR <60 ml/min/1.73m2 • Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging • Use of finasteride (PROSCAR®, Propecia®), dutasteride (AVODART®), leuprolide acetate (Lupron Depot®), or other medications or hormones (within the past 3 months) that are known to affect serum PSA levels. • Symptoms of urinary tract infection (including prostatitis) at the time of enrolment. • History of invasive treatments for BPH or lower urinary tract symptoms (LUTS), e.g. transurethral resection of the prostate (TURP), heat, laser, or ultrasound treatments in the last 6 months. • History of illness that the investigator/physician considers to interfere with or affect the conduct, results, and/or completion of the study. • Participation in a pharmaceutical or treatment-related clinical study or receipt of treatment for a prostate-related condition within the last six months of enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the additional value of mp-MRI and MRI-guided biopsy in men with an elevated PSA regarding the detection of both insignificant and significant cancer, and reducing biopsies. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the cost-effectiveness of such an additional mp-MRI-procedure compared to random TRUS-guided biopsy, which is “standard of care”. To determine the influence of both procedures on quality of life. To determine the added value of the prostate risk calculator, Quattro urine test and mp-MRI. To define the optimal PSA threshold as from 3 ng/ml for proceeding to performing prostate biopsies To investigate the accuracy of the Gleason scores of positive biopsies in predicting the definite Gleason score of available radical prostatectomy specimens | — |
Contacts
Public ContactJ.O. Barentsz
Geert Grooteplein-Zuid 10
Outcome results
None listed