To evaluate the diagnostic performance and cost-effectiveness of the MRI-driven diagnostic pathway of prostate cancer, with upfront individual multivariate risk stratification.
Screening for prostate cancer (PCa) remains one of the most controversial issues in urological practice. Although robust data from the European Randomised study of Screening for Prostate Cancer (ERSPC) suggest a disease specific survival benefit in favor of prostate-specific antigen (PSA)-based PCa screening, the coinciding unfavorable harm-benefit precludes that PCa screening can be adopted as a public health policy. The diagnostic pathway needs to be optimized to reduce unnecessary testing and to avoid diagnosing those cancers that will never harm a patient if not detected through screening. Some men may thus benefit from PCa screening, but with the currently used diagnostics (i.e. the PSA test and systematic TRUS (transrectal ultrasound )-guided prostate biopsy) many more men are harmed by unnecessary testing and the cascade of diagnostic and treatment related events that follow. Further refinements to screening strategies, focusing on detecting only those PCa that are potentially life threatening (clinically significant) are needed to become acceptable to the general population and health care providers. The investigators propose such a refinement within this protocol, with upfront individual risk prediction and in addition a MRI-driven diagnostic pathway in only those men that are considered to be at intermediate/high-risk of having a potentially life threatening PCa (in general defined as Gleason sum Score (GS) =7).
Study Type
OBSERVATIONAL
Enrollment
2,558
prostate biopsy
Erasmusmc
Rotterdam, South Holland, Netherlands
Proportion of detected csPCa
Proportion of study population with clinically significant prostate cancer (csPCa), correctly identified by Risk-assessment + MRI-driven pathway
Time frame: 36 months
Number of biopsy procedures in relation to detected csPCa.
Number of prostate biopsy procedures in relation to the detection of clinically significant prostate cancer.
Time frame: 36 months
Proportion of unnecessary TRUS-guided and targeted biopsies
Proportion of TRUS-guided and targeted biopsies that could have been avoided safely.
Time frame: 36 months
CEA Risk stratification-MRI
Diagnostic health care cost-effectiveness analysis (CEA) of Risicowijzer-MRI-driven pathway.
Time frame: 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.