Clinical trial NCT03225222: MRI in PROstate Cancer Diagnosis With Prior Risk Assessment
Official title: MRI in PROstate Cancer Diagnosis With Prior Risk Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate cancer
multivariate risk assessment
MRI
biopsy
screening
multicenter
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 2558
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men are eligible for the study if there is a clinical suspicion of harbouring prostate cancer without previous prostate biopsies. This essentially includes men with an elevated PSA (≥ 3 ng/ml) and/or a suspicious DRE, or family history of prostate cancer.

Brief summary: To evaluate the diagnostic performance and cost-effectiveness of the MRI-driven diagnostic pathway of prostate cancer, with upfront individual multivariate risk stratification.

Detailed description: 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).

Eligibility criteria: Inclusion criteria:

* men ≥ 50 years,
* no prior prostate biopsies,
* suspected of having prostate cancer based on PSA blood test (≥ 3 ng/ml) and/or DRE( digital rectal examination) and/or family history of prostate cancer,
* fit to undergo all protocol procedures,
* signed informed consent.

Exclusion criteria:

* contra-indications to MRI or TRUS biopsy procedures,
* any medical condition precluding procedures described in the protocol

Primary outcomes:
measure: Proportion of detected csPCa
timeFrame: 36 months
Secondary outcomes:
measure: Number of biopsy procedures in relation to detected csPCa.
timeFrame: 36 months
measure: Proportion of unnecessary TRUS-guided and targeted biopsies
timeFrame: 36 months
measure: CEA Risk stratification-MRI
timeFrame: 36 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmusmc
state: Zuid Holland
Study officials:
affiliation: Erasmus Medical Center
name: Ivo Schoots, Dr
role: PRINCIPAL_INVESTIGATOR
References: