Prostate Cancer Screening: a Pilot Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Urology visit with Risk Calculator and MRI: Patients with PSA ≥3 ng/ml will undergo urology visit with risk calculator and MRI assessment of the prostate

Study summary

Prostate Cancer (PCa) is the second most frequently diagnosed tumour and the third most lethal among men in Europe. The lack of precise tools and examinations to precisely diagnose PCa has caused overtreatment of indolent and low-aggressive PCa, while in some other cases, with aggressive disease, diagnosis and treatment are dangerously delayed because cancer could be potentially missed. The present trial aims to study a new pathway to early diagnose PCa with Magnetic Resonance Imaging (MRI) to identify men who will not need treatment and those who will benefit from radical treatment, thus improving disease control and quality of life.

Eligibility

Primary outcome measure(s)

• Detection rate of clinically significant prostate cancer (Gleason Group ≥2) — 24 months
  No. of detected clinically significant prostate cancer with Gleason Group ≥ 2 over the total no. of men enrolled in the trial
• Comparison of the detection rate of clinically significant prostate cancer with and without screening — 24 months
  No. of detected clinically significant prostate cancer with Gleason Group ≥ 2 over the total no. of men enrolled in the trial compared to the same proportion of men calculated in the 2-year period before the introduction of the screening protocol
• Verify that the detection rate of clinically significant prostate cancer with the screening strategy is not inferior to that of the Italian cohort in the ERSPC study — 24 months
  No. of detected clinically significant prostate cancer with Gleason Group ≥ 2 over the total no. of men enrolled in the trial compared to the same proportion of men included in the Italian cohort of the ERSPC study screened using PSA only

Trial sites (1)

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