Evidence-based guideline recommendations on multiparametric magnetic resonance imaging in the diagnosis of clinically significant prostate cancer

Question 1

What is the primary purpose of the clinical practice guideline discussed in the abstract?

Answer 1

The clinical practice guideline assesses the use of multiparametric magnetic resonance imaging (mpMRI) in the diagnosis of clinically significant prostate cancer (csPCa) for biopsy-naive men and men with a prior negative transrectal ultrasound-guided systematic biopsy (TRUS-SB) at elevated risk.

Question 2

For biopsy-naive patients at elevated risk of csPCa, when is an mpMRI recommended?

Answer 2

mpMRI is recommended prior to biopsy in patients who are candidates for curative management with suspected clinically localized prostate cancer.

Question 3

If the mpMRI is positive for a biopsy-naive patient at elevated risk of csPCa, what is the recommended next step?

Answer 3

Perform both an mpMRI-targeted biopsy (TB) and TRUS-SB together to maximize the detection of csPCa.

Question 4

What should be considered if the mpMRI is negative for a biopsy-naive patient?

Answer 4

Consider forgoing any biopsy, but only after discussing the risks and benefits with the patient as part of shared decision-making and committing to ongoing follow-up.

Question 5

For patients with a prior negative TRUS-SB at high risk of csPCa, what is the recommended approach if their mpMRI is positive?

Answer 5

For patients with a prior negative TRUS-SB at high risk of csPCa, what is the recommended approach if their mpMRI is positive?

Question 6

For patients with a prior negative TRUS-SB and a negative mpMRI, what is the guideline’s recommendation?

Answer 6

Consider forgoing a TRUS-SB, but only after discussing the risks and benefits with the patient as part of shared decision-making and committing to ongoing follow-up.

Question 7

What specific guidelines should the interpretation of mpMRI comply with?

Answer 7

mpMRI should be interpreted in compliance with the current Prostate Imaging Reporting & Data System (PI-RADS) guidelines.

Question 8

What is the most common cancer among Canadian men, excluding non-melanoma skin cancers?

Answer 8

Prostate cancer.

Question 9

What position does prostate cancer hold in terms of causing death among Canadian male cancer patients?

Answer 9

It is the third leading cause.

Question 10

What is the current standard for diagnosing clinically significant prostate cancer (csPCa) in biopsy-naive men at risk in most clinical practices?

Answer 10

TRUS-guided systematic biopsy (TRUS-SB) of 10–12 cores.

Question 11

Which alternative biopsy method is less commonly applied in Canada compared to TRUS-SB?

Answer 11

Transperineal systematic biopsy.

Question 12

Why can TRUS-SB lead to over-detection of clinically insignificant prostate cancer (cisPCa)?

Answer 12

Because it systematically samples areas from the prostate and not a specific imaged target.

Question 13

Over the recent years, which non-invasive tool has been growing in use to diagnose and localize csPCa?

Answer 13

Multiparametric magnetic resonance imaging (mpMRI).

Question 14

For what specific group might mpMRI followed by targeted biopsy (mpMRI-TB) be considered, particularly in men with what history?

Answer 14

It may be considered in the detection of csPCa, particularly in men with prior negative biopsy.

Question 15

At the time of the previous Ontario provincial guidelines, what was lacking concerning the use of mpMRI-TB in biopsy-naive men?

Answer 15

There was a paucity of high-quality data supporting its use.

Question 16

Were there Canadian guidelines addressing the minimum acceptable standards in the acquisition, interpretation, and reporting of mpMRI or mpMRI-TB performance?

Answer 16

No, there were no Canadian guidelines published for these standards.

Question 17

Who conducted the update of the systematic review to develop a clinical practice guideline assessing the use of mpMRI in the diagnosis of csPCa?

Answer 17

The Working Group (WG) guideline authors (with expertise in diagnostic imaging, radiation oncology, urology, and health research methodology), in association with the Program in Evidence-based Care (PEBC) of Ontario Health (Cancer Care Ontario) and the mpMRI in Prostate Cancer Guideline Development Group (GDG).

Question 18

When was the systematic review for the updated clinical practice guideline on mpMRI in prostate cancer diagnosis conducted?

Answer 18

The systematic review was conducted from May 2013 through September 1, 2020.

Question 19

Which databases were searched during the systematic review?

Answer 19

MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (OVID CCTR), and the Database of Abstracts of Reviews of Effects (OVID DARE).

Question 20

What types of publications were searched for in the systematic review?

Answer 20

Systematic reviews, review-based guidelines, original studies, and conference abstracts.

Question 21

Who assessed and approved the report?

Answer 21

The PEBC Report Approval Panel (RAP) assessed and approved the report. It consisted of two oncologists with expertise in clinical and methodological issues.

Question 22

What is the role of the mpMRI in the Diagnosis of Clinically Significant Prostate Cancer Expert Panel (EP)?

Answer 22

The EP is a larger group of radiologists, urologists, and surgical oncologists. Some members of this panel were selected to form the Working Group (WG) which reviewed and approved the report.

Question 23

After the RAP and EP’s approval, what two significant steps were taken?

Answer 23

A targeted peer review was conducted with specified content experts, followed by a professional consultation intended to facilitate the dissemination of the final guidance report to Ontario practitioners.

Question 24

What was the purpose of the study on multiparametric MRI in the diagnosis of clinically significant prostate cancer?

Answer 24

To provide evidence-based guideline recommendations.

Question 25

How many studies were identified in the literature search?

Answer 25

3754 studies.

Question 26

How many of the identified studies met the inclusion criteria?

Answer 26

36 studies from 39 publications.

Question 27

What was the range of the overall risk of bias for the included studies?

Answer 27

The risk ranged from low to high.

Question 28

What are the guidelines related to?

Answer 28

The guidelines are related to the use of multiparametric magnetic resonance imaging (mpMRI) in diagnosing clinically significant prostate cancer (csPCa).

Question 29

For biopsy-naive patients at elevated risk of csPCa, when is mpMRI recommended?

Answer 29

mpMRI is recommended prior to biopsy in patients who are candidates for curative management with suspected clinically localized prostate cancer.

Question 30

If the mpMRI is positive, what procedures should be performed?

Answer 30

If the mpMRI is positive, both mpMRI-TB (Targeted Biopsy) and TRUS-SB (Transrectal Ultrasound-guided Systematic Biopsy) should be performed together to maximize the detection of csPCa.

Question 31

If the mpMRI is negative, what should be considered?

Answer 31

If the mpMRI is negative, consider forgoing any biopsy. However, this should be done after discussing the risks and benefits with the patient as part of shared decision-making, followed by ongoing follow-up.

Question 32

What were the sensitivity and specificity ranges of mpMRI in the studies where TTMB was the reference standard?

Answer 32

Sensitivity ranged from 87-96% and specificity ranged from 29-45%.

Question 33

In the PROMIS study, how did the sensitivity and specificity of mpMRI compare to TRUS-SB?

Answer 33

In the PROMIS study, how did the sensitivity and specificity of mpMRI compare to TRUS-SB?

Question 34

How did the detection rates of csPCa and cisPCa in two RCTs compare between mpMRI-TB and TRUS-SB?

Answer 34

csPCa detection favored mpMRI by 18%. For cisPCa, detection favored mpMRI by 9%

Question 35

In the MRI-FIRST study, were there significant differences in csPCa detection between mpMRI-TB and TRUS-SB?

Answer 35

No, the detection of csPCa was similar (32% vs. 30%). However, mpMRI-TB detected significantly less cisPCa than TRUS-SB.

Question 36

What is the principal value of mpMRI in biopsy-naive patients?

Answer 36

: The principal value is biopsy avoidance, with up to a 49% reduction in biopsies if mpMRI-negative patients are not biopsied.

Question 37

What are some complications associated with TRUS-SB?

Answer 37

Complications include urosepsis, urinary retention, hematuria, and rectal bleeding.

Question 38

: Why is targeted biopsy plus systematic biopsy believed to be necessary if mpMRI is positive in biopsy-naive patients?

Answer 38

: Why is targeted biopsy plus systematic biopsy believed to be necessary if mpMRI is positive in biopsy-naive patients?

Question 39

What is the recommendation for patients with a prior negative TRUS-SB demonstrating a high risk of having csPCa and considering curative management?

Answer 39

Perform an mpMRI.
If mpMRI is positive, execute a targeted biopsy. Depending on the patient’s risk profile and time since the prior TRUS-SB biopsy, a concomitant TRUS-SB can also be considered.
If mpMRI is negative, consider bypassing a TRUS-SB, but only after discussing the risks and benefits with the patient, ensuring shared decision-making and continuous follow-up.

Question 40

How many trials compared mpMRI with a reference standard or with TRUS-SB for men with previously negative results?

Answer 40

Twenty-two trials. 15 of these studies showed low to moderate or unclear risk of bias based on the GRADE approach.

Question 41

What were the reported diagnostic accuracy metrics of mpMRI for previously negative patients?

Answer 41

Sensitivities between 78-100%, specificities of 30-100%, PPVs of 36-100%, and NPVs of 69-100%.

Question 42

What was the overall improvement in csPCa detection rate when comparing mpMRI-TB alone to TRUS-SB?

Answer 42

5% improvement (95% CI 3–7, p<0.0001), with a reduction of cisPCa detection of 7% (95% CI 4–9, p<0.00001).

Question 43

How did the csPCa detection rate change when comparing mpMRI-TB plus TRUS-SB to mpMRI-TB alone?

Answer 43

5% improvement (95% CI 2–8, p=0.0005).

Question 44

What was the overall csPCa detection improvement when comparing mpMRI-TB plus TRUS-SB to TRUS-SB alone?

Answer 44

11% improvement (95% CI 8–14, p<0.00001).

Question 45

According to the justification for the recommendation, how does mpMRI-TB fare against TRUS-SB in detecting csPCa?

Answer 45

All eligible studies indicate that mpMRI-TB detects a higher number of csPCa compared to TRUS-SB.

Question 46

What is the main focus of Recommendation 3 in the provided guideline?

Answer 46

The main focus is the use and interpretation of mpMRI in the diagnosis of clinically significant prostate cancer.

Question 47

According to Recommendation 3, with which system should the mpMRI be performed and interpreted?

Answer 47

The mpMRI should be performed and interpreted in compliance with the current Prostate Imaging Reporting & Data System (PI-RADS) guidelines (v2.1 as of summer 2020).

Question 48

What is the recommended action for MRI lesions with a PI-RADS score of 4 or 5?

Answer 48

mpMRI-TB (targeted biopsy) is recommended.

Question 49

mpMRI-TB (targeted biopsy) is recommended.

Answer 49

Either mpMRI-TB (targeted biopsy) or follow-up is recommended.

Question 50

What should be considered when the maximum PI-RADS score is 1 or 2?

Answer 50

Biopsy avoidance should be considered.

Question 51

What type of reporting template is recommended when interpreting mpMRI results?

Answer 51

A structured mpMRI reporting template as recommended by the PI-RADS committee.

Question 52

When a targeted biopsy is performed, what is the recommended minimum and maximum number of cores to be taken per target

Answer 52

A minimum of two cores should be taken per target, with a recommendation of four cores for the index lesion.

Question 53

If multiple lesions are described on mpMRI, what should the biopsy operator consider?

Answer 53

The biopsy operator may distribute the number of biopsies to keep a reasonable overall core count during the biopsy session.

Question 54

Who should perform mpMRI interpretation and mpMRI-TB?

Answer 54

Experienced operators.

Question 55

What is recommended regarding quality assurance for mpMRI interpretation and mpMRI-TB?

Answer 55

A provincial quality assurance program should be developed. Until this is in place, practitioners should have some form of local quality assurance.

Question 56

On what is Recommendation 3 primarily based?

Answer 56

It’s based on expert opinion, review of the PI-RADS committee guidelines, and the Standard Operating Procedure of the American Urological Association (AUA).

Question 57

How many cores per lesion have been performed in recent MCTs evaluating mpMRI?

Answer 57

: Four cores per lesion.

Question 58

Why is it important for radiologists and practitioners to have experience and demonstrate consistent performance levels for mpMRI and mpMRI-TB?

Answer 58

Why is it important for radiologists and practitioners to have experience and demonstrate consistent performance levels for mpMRI and mpMRI-TB?

Question 59

Before implementing mpMRI in clinical practice, what key considerations should be made?

Answer 59

Radiologists and treating physicians should be familiar with current PI-RADS prostate MRI technical specifications and reporting standards. The patient care pathway and incorporation of mpMRI in Ontario requires ongoing evaluation for impact on patient care and outcomes.

Question 60

Why is attention to quality assurance critical when considering the value of mpMRI?

Answer 60

Due to moderate agreement in PI-RADS scoring and a wide CI for PPVs of PI-RADS score ≥3 (35%, 95% CI 27–43%). There’s no quality assurance program in place for mpMRI in Ontario or nationally. Quality assurance ensures accurate, consistent, and reliable interpretations.

Question 61

Which metrics are suggested for collecting when developing a quality assurance program for mpMRI?

Answer 61

Target yield (number of csPCa detected per lesion biopsied), stratified by PI-RADS score, and the number of false-negative mpMRI instances (where mpMRI is negative but csPCa is diagnosed at TRUS-SB or prostatectomy).

Question 62

What are some of the resource implications and concerns when implementing the guidelines on mpMRI?

Answer 62

Limited MRI resources in Canada, potential requirement for cognitive fusion biopsy due to lack of computer/software-aided fusion biopsy systems, and cost implications, especially in the biopsy-naive populatio

Question 63

Why is the use of bpMRI being considered and what are its potential benefits?

Answer 63

By omitting the dynamic contrast-enhanced MRI (DCEMRI) from mpMRI, savings in contrast agent cost and MRI time can be achieved. Relevant due to expected increase in prostate MRI volume. Some studies show non-inferiority of bpMRI to mpMRI.

Question 64

What are the prevailing concerns regarding bpMRI use over mpMRI?

Answer 64

Concerns stem from the retrospective nature of studies and potential increase in indeterminate (PI-RADS 3) interpretations using only bpMRI. Prospective trials comparing bpMRI and mpMRI are lacking.

Question 65

What is anticipated regarding the use of bpMRI vs. mpMRI in the future?

Answer 65

Additional evidence on tradeoffs between mpMRI and bpMRI related to cost, safety, decision-making, and outcomes may alter practice. Given resource pressures, bpMRI can be an alternative to mpMRI if monitored carefully.