Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Michal Standara, MD
CONTACT
Jan Křístek, MD, PhD
CONTACT
Lead
Masaryk Memorial Cancer Institute
With
A prospective cross-sectional (with a longitudinal component, 2nd screening round) study evaluating the possibility of using the biparametric MRI protocol technique for screening clinically significant prostate cancer in men from the general population. Tests performed: * Serum PSA * PHI calculation (Prostate Health Index) to be performed only if the PSA values are in the range of 2-10 ng/l * MRI of the prostate (abbreviated biparametric protocol) * Digital rectal examination (DRE) as part of a clinical visit at a urologist in patients with a positive PSA test * Biopsy - if indicated MRI specifications: * Protocol with anatomical T2 sequence and diffusion-weighted images (DWI), according to the standards * Typical complete examination time does not exceed 20 minutes, planned acquisition time less than 15 minutes. * No contrast agent or spasmolytics is injected. Blinding: * Every test evaluator (radiologist/urologist) does not know the results of other tests. · MRI reports entered in the registry obligatorily before the biopsy. * The patient is not informed which test was positive and resulted in an indication for biopsy. * The pathologist does not know the results of MRI or laboratory tests. The sequence of tests: The MRI is assessed with the PI-RADS 2.1 system, each finding is reported on a scale of 1-5. To minimize the detection of non-significant cancers and to reduce the number of biopsies according to the results of the IP1-Prostagram study, a PI-RADS value of 4-5 was chosen as a positive test representation. Consensual double reading by 2 experienced uroradiologists (at least 400 MRI of the prostate read by the beginning of the study). Men with a positive MRI test are planned for a targeted MRI/US fusion and systematic prostate biopsy. Men with a positive blood marker (either PSA, PSAD, or PHI) are planned for a systematic 12 core biopsy. Positive test results are PSA ≥ 3, integrated marker PSAD ≥ 0.15, and PHI ≥ 35. Study participants are invited to repeat the screening tests after 2 years by letter. If they do not respond to a written offer, also by e-mail and SMS. Definition of clinically significant cancer: • ISUP Grade Group ≥ 2.
Age
50–69
Sex
MALE
Healthy volunteers
Accepted
