MRI Versus PSA in Prostate Cancer Screening

In this open randomized controlled trial, we seek to study whether prostate cancer screening using multiparametric prostate magnetic resonance imaging (mpMRI) improves the detection rate of clinically-significant prostate cancer (defined as Gleason score ≥7 on prostate biopsy) compared with prostate cancer screening using prostate-specific antigen (PSA). The current paradigm of prostate cancer screening relies upon an initial PSA blood test, with subsequent investigations driven by the serum PSA level. This model has proven highly controversial due to the inability of PSA level to discern between indolent and aggressive forms of prostate cancer. As a result, numerous government-sponsored bodies have recommended against PSA screening. Evidence suggests that prostate cancer screening has led to an increased proportion of men being diagnosed with potentially curable prostate cancer. However, due to the inability of the PSA level to accurately distinguish patients with indolent and lethal forms of prostate cancer, it has led to a significant rate of over-diagnosis of indolent disease. Magnetic resonance imaging has been gaining an increasingly large role in the management of patients with clinically-localized prostate cancer including diagnosis in patients with abnormal PSA levels, monitoring of patients on active surveillance and staging prior to definitive interventions. MRI-based prostate cancer risk assessment has been shown to better distinguish between clinically-significant and insignificant tumors than PSA test. Therefore, a randomized controlled trial of MRI-based prostate cancer screening and PSA-based prostate cancer screening is warranted.

Sex

Male

Minimum age

50 Years

Inclusion Criteria:

* age greater than or equal to 50 years old
* life expectancy greater than or equal to 10 years, according to the clinical judgement of study investigators

Exclusion Criteria:

* history of previous prostate biopsy
* PSA level measurement within 3 years of recruitment date
* abnormal digital rectal examination of the prostate consistent with prostate cancer
* history of prostate cancer in one or more first-degree relatives diagnosed at less than 50 years of age
* lower urinary tract voiding symptoms (IPSS greater than or equal to 8)
* prior or current use of 5-alpha reductase inhibitor medications (finasteride or dutasteride)
* patient unable to communicate in English in order to give proper informed consent
* claustrophobia or other medical indication which would preclude MRI
* any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives

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