Multiparametric Magnetic Resonance Imaging in the Diagnosis of Clinically Significant Prostate Cancer

Guideline Objective:

To make recommendations with respect to:

1. a) The use of multiparametric magnetic resonance imaging (MPMRI) in patients with an elevated risk of clinically significant prostate cancer (CSPCa) who are biopsy naïve,

b) The use of MPMRI-targeted biopsy plus transrectal ultrasound systematic biopsy (TRUS-SB) or MPMRI-TB alone for biopsy-naïve patients who have undergone MPMRI;

2. a) The use of MPMRI in patients with an elevated risk of CSPCa who have had a prior negative TRUS-SB for any prostate cancer,

b) The use of MPMRI-TB plus TRUS-SB or MPMRI-TB alone for patients who have had a prior negative TRUS-SB defined as no prostate cancer on biopsy of any grade group,

3. The minimum acceptable standards in the acquisition, interpretation and reporting of MPMRI and the minimal acceptable standards for performance of MPMRI-TB.

Patient Population:

Patients with an elevated risk of CSPCa (defined as International Society of Urologic Pathology [ISUP] Grade Group [GG] ≥2), as estimated by available clinical information and tools such as risk calculators and nomograms, of who are A) biopsy naïve or B) have had a prior negative TRUS-SB defined as no prostate cancer on biopsy of any grade group.

Intended Guideline Users:

Radiologists, oncologists, urologists, and other clinicians who provide care for patients defined by the target population.

Research Questions:

Q1a. For biopsy-naïve patients at elevated risk (according to PSA levels and/or nomograms), how accurately does MPMRI or MPMRI followed by targeted biopsy diagnose CSPCa (GG ≥2), compared with the reference standard?

Q1b. For biopsy-naïve patients at elevated risk, does MPMRI followed by targeted biopsy increase the detection rate of CSPCa (GG ≥2) and reduce the detection rate of CISPCa positively change patient management, or improve patient outcomes (including side effects and survival outcomes), compared with TRUS-SB (of at least eight cores)?

Q1c. For biopsy-naïve patients at elevated risk, does MPMRI followed by targeted and systematic biopsies improve the detection rate of CSPCa and reduce the detection rate of CISPCa, positively change patient management, or improve patient outcomes (including side effects and survival outcomes), compared with TRUS-SB alone (of at least eight cores) or targeted biopsy alone?

Q2a. For patients with prior negative TRUS-guided biopsy at elevated risk, how accurately does MPMRI or MPMRI followed by targeted biopsy diagnose CSPCa, compared with the reference standard?

Q2b. For patients with prior negative TRUS-SB at elevated risk, does MPMRI followed by targeted biopsy increase the detection rate of CSPCa and reduce the detection rate of CISPCa, positively change patient management, or improve patient outcomes (including survival outcomes and adverse events), compared with TRUS-SB (of at least eight cores)?

Q2c. For patients with prior negative TRUS-SB at elevated risk, does MPMRI followed by targeted and systematic biopsies improve the detection rate of CSPCa and reduce the detection rate of CISPCa, positively change patient management, or improve patient outcomes (including side effects and survival outcomes), compared with TRUS-SB alone (of at least eight cores) or targeted biopsy alone?

Q3a. What are the minimum acceptable standards to perform and report MPMRI for patients with an elevated risk of CSPCa who have been decided to undergo MPMRI examination?

Q3b. What are the minimum acceptable standards for performance of image-guided targeted biopsy for patients with an elevated?