MRI matches standard biopsy at detecting significant prostate cancers

Men who dread the prospect of multicore prostate biopsies can take heart in the news that multiparametric MRI with or without targeted biopsy was noninferior to transrectal ultrasound at detecting clinically significant cancers, results of a multicenter randomized trial indicate.

The rate of clinically significant cancers detected in men with clinical suspicion of prostate cancer who were randomly assigned to undergo MRI was 38%, compared with 26% (P = .005) for men assigned to standard transrectal ultrasound guided biopsy with 10 or 12 biopsy cores, reported Veeru Kasivisvanathan, MRCS, of University College London, and colleagues in the PRECISION trial (Prostate Evaluation for Clinically Important Disease: Sampling Using Image-guidance or Not?).

Significantly fewer men assigned to MRI-targeted biopsy were diagnosed with clinically insignificant cancers, suggesting that MRI could help to reduce the number of invasive biopsies and the associated pain, discomfort, and infection risks, the investigators stated in the New England Journal of Medicine.

“MRI, with or without targeted biopsy, led to fewer men undergoing biopsy, more clinically significant cancers being identified, less overdetection of clinically insignificant cancer, and fewer biopsy cores being obtained than did standard transrectal ultrasonography-guided biopsy,” they wrote.

Multiparametric MRI combines several different imaging modalities, including standard T1- and T2-weighted scans with dynamic contrast–enhanced and/or diffusion-weighted imaging to provide a wealth of information to aid in diagnosis. The technique has been shown in single-center studies to be similar or superior to ultrasound guided biopsy at detecting clinically significant cancers and minimizing detection of cancers that turn out to be clinically insignificant, the investigators said.

To add to the body of evidence, investigators from 25 centers in 11 countries randomized a total of 500 men with clinical suspicion of prostate cancer and no history of prostate biopsy to undergo either MRI plus targeted biopsy (not 10- or 12-core biopsy) if the scans indicated suspicion of malignancy, or standard transrectal ultrasound-guided biopsy with 10 or 12 core samples.

The investigators defined clinically significant cancer as the presence of a single biopsy core indicating disease of Gleason score 3 plus 4 (Gleason sum of 7), or greater.

 

Of the 252 men assigned to MRI, 71 (28%) had results that did not suggest prostate cancer, and these men did not undergo biopsy.

As noted before, MRI was noninferior to standard ultrasound-guided biopsy. In the MRI group, 95 men (38%) were determined to have clinically significant tumors, compared with 64 of 248 men (26%) in the standard biopsy group.

Getting down into the statistical weeds, the lower boundary of the 95% confidence interval for the difference was greater than −5%, showing that MRI with or without targeted biopsy was noninferior to standard transrectal ultrasonography-guided biopsy for the detection of clinically significant cancers. In fact, the 95% confidence interval for the 12-point difference between the two techniques (95% confidence interval, 4-20) showed that MRI was superior to standard biopsy, the authors stated.

There were no health-related quality of life differences at either 24 hours or 30 days after the procedure, and immediate postintervention discomfort and pain were also similar between the groups. However, patient-reported complications were lower in patients assigned to MRI, including blood in urine (30% vs. 63% for standard biopsy), blood in semen (32% vs. 60%), procedural-site pain (13% vs. 23%), rectal bleeding (14% vs. 22%), and erectile dysfunction (11% vs. 16%).

 

“We found that a diagnostic pathway including risk assessment with MRI before biopsy and MRI-targeted biopsy in the presence of a lesion suggestive of cancer was superior to the diagnostic pathway of standard transrectal ultrasonography-guided biopsy,” Dr. Kasivisvanathan and his associates concluded.

The study was supported by awards to Dr. Kasivisvanathan from the U.K. National Institute for Health Research and by the European Association of Urology Research Foundation. He reported no other significant conflicts of interest to disclose.

 

SOURCE: Kasivisvanathan V et al. N Engl J Med. 2018 Mar 19. doi: 10.1056/NEJMoa1801993.

Men who dread the prospect of multicore prostate biopsies can take heart in the news that multiparametric MRI with or without targeted biopsy was noninferior to transrectal ultrasound at detecting clinically significant cancers, results of a multicenter randomized trial indicate.

The rate of clinically significant cancers detected in men with clinical suspicion of prostate cancer who were randomly assigned to undergo MRI was 38%, compared with 26% (P = .005) for men assigned to standard transrectal ultrasound guided biopsy with 10 or 12 biopsy cores, reported Veeru Kasivisvanathan, MRCS, of University College London, and colleagues in the PRECISION trial (Prostate Evaluation for Clinically Important Disease: Sampling Using Image-guidance or Not?).

Significantly fewer men assigned to MRI-targeted biopsy were diagnosed with clinically insignificant cancers, suggesting that MRI could help to reduce the number of invasive biopsies and the associated pain, discomfort, and infection risks, the investigators stated in the New England Journal of Medicine.

“MRI, with or without targeted biopsy, led to fewer men undergoing biopsy, more clinically significant cancers being identified, less overdetection of clinically insignificant cancer, and fewer biopsy cores being obtained than did standard transrectal ultrasonography-guided biopsy,” they wrote.

Multiparametric MRI combines several different imaging modalities, including standard T1- and T2-weighted scans with dynamic contrast–enhanced and/or diffusion-weighted imaging to provide a wealth of information to aid in diagnosis. The technique has been shown in single-center studies to be similar or superior to ultrasound guided biopsy at detecting clinically significant cancers and minimizing detection of cancers that turn out to be clinically insignificant, the investigators said.

To add to the body of evidence, investigators from 25 centers in 11 countries randomized a total of 500 men with clinical suspicion of prostate cancer and no history of prostate biopsy to undergo either MRI plus targeted biopsy (not 10- or 12-core biopsy) if the scans indicated suspicion of malignancy, or standard transrectal ultrasound-guided biopsy with 10 or 12 core samples.

The investigators defined clinically significant cancer as the presence of a single biopsy core indicating disease of Gleason score 3 plus 4 (Gleason sum of 7), or greater.

 

Of the 252 men assigned to MRI, 71 (28%) had results that did not suggest prostate cancer, and these men did not undergo biopsy.

As noted before, MRI was noninferior to standard ultrasound-guided biopsy. In the MRI group, 95 men (38%) were determined to have clinically significant tumors, compared with 64 of 248 men (26%) in the standard biopsy group.

Getting down into the statistical weeds, the lower boundary of the 95% confidence interval for the difference was greater than −5%, showing that MRI with or without targeted biopsy was noninferior to standard transrectal ultrasonography-guided biopsy for the detection of clinically significant cancers. In fact, the 95% confidence interval for the 12-point difference between the two techniques (95% confidence interval, 4-20) showed that MRI was superior to standard biopsy, the authors stated.

There were no health-related quality of life differences at either 24 hours or 30 days after the procedure, and immediate postintervention discomfort and pain were also similar between the groups. However, patient-reported complications were lower in patients assigned to MRI, including blood in urine (30% vs. 63% for standard biopsy), blood in semen (32% vs. 60%), procedural-site pain (13% vs. 23%), rectal bleeding (14% vs. 22%), and erectile dysfunction (11% vs. 16%).

 

“We found that a diagnostic pathway including risk assessment with MRI before biopsy and MRI-targeted biopsy in the presence of a lesion suggestive of cancer was superior to the diagnostic pathway of standard transrectal ultrasonography-guided biopsy,” Dr. Kasivisvanathan and his associates concluded.

The study was supported by awards to Dr. Kasivisvanathan from the U.K. National Institute for Health Research and by the European Association of Urology Research Foundation. He reported no other significant conflicts of interest to disclose.

 

SOURCE: Kasivisvanathan V et al. N Engl J Med. 2018 Mar 19. doi: 10.1056/NEJMoa1801993.

Men who dread the prospect of multicore prostate biopsies can take heart in the news that multiparametric MRI with or without targeted biopsy was noninferior to transrectal ultrasound at detecting clinically significant cancers, results of a multicenter randomized trial indicate.

The rate of clinically significant cancers detected in men with clinical suspicion of prostate cancer who were randomly assigned to undergo MRI was 38%, compared with 26% (P = .005) for men assigned to standard transrectal ultrasound guided biopsy with 10 or 12 biopsy cores, reported Veeru Kasivisvanathan, MRCS, of University College London, and colleagues in the PRECISION trial (Prostate Evaluation for Clinically Important Disease: Sampling Using Image-guidance or Not?).

Significantly fewer men assigned to MRI-targeted biopsy were diagnosed with clinically insignificant cancers, suggesting that MRI could help to reduce the number of invasive biopsies and the associated pain, discomfort, and infection risks, the investigators stated in the New England Journal of Medicine.

“MRI, with or without targeted biopsy, led to fewer men undergoing biopsy, more clinically significant cancers being identified, less overdetection of clinically insignificant cancer, and fewer biopsy cores being obtained than did standard transrectal ultrasonography-guided biopsy,” they wrote.

Multiparametric MRI combines several different imaging modalities, including standard T1- and T2-weighted scans with dynamic contrast–enhanced and/or diffusion-weighted imaging to provide a wealth of information to aid in diagnosis. The technique has been shown in single-center studies to be similar or superior to ultrasound guided biopsy at detecting clinically significant cancers and minimizing detection of cancers that turn out to be clinically insignificant, the investigators said.

To add to the body of evidence, investigators from 25 centers in 11 countries randomized a total of 500 men with clinical suspicion of prostate cancer and no history of prostate biopsy to undergo either MRI plus targeted biopsy (not 10- or 12-core biopsy) if the scans indicated suspicion of malignancy, or standard transrectal ultrasound-guided biopsy with 10 or 12 core samples.

The investigators defined clinically significant cancer as the presence of a single biopsy core indicating disease of Gleason score 3 plus 4 (Gleason sum of 7), or greater.

 

Of the 252 men assigned to MRI, 71 (28%) had results that did not suggest prostate cancer, and these men did not undergo biopsy.

As noted before, MRI was noninferior to standard ultrasound-guided biopsy. In the MRI group, 95 men (38%) were determined to have clinically significant tumors, compared with 64 of 248 men (26%) in the standard biopsy group.

Getting down into the statistical weeds, the lower boundary of the 95% confidence interval for the difference was greater than −5%, showing that MRI with or without targeted biopsy was noninferior to standard transrectal ultrasonography-guided biopsy for the detection of clinically significant cancers. In fact, the 95% confidence interval for the 12-point difference between the two techniques (95% confidence interval, 4-20) showed that MRI was superior to standard biopsy, the authors stated.

There were no health-related quality of life differences at either 24 hours or 30 days after the procedure, and immediate postintervention discomfort and pain were also similar between the groups. However, patient-reported complications were lower in patients assigned to MRI, including blood in urine (30% vs. 63% for standard biopsy), blood in semen (32% vs. 60%), procedural-site pain (13% vs. 23%), rectal bleeding (14% vs. 22%), and erectile dysfunction (11% vs. 16%).

 

“We found that a diagnostic pathway including risk assessment with MRI before biopsy and MRI-targeted biopsy in the presence of a lesion suggestive of cancer was superior to the diagnostic pathway of standard transrectal ultrasonography-guided biopsy,” Dr. Kasivisvanathan and his associates concluded.

The study was supported by awards to Dr. Kasivisvanathan from the U.K. National Institute for Health Research and by the European Association of Urology Research Foundation. He reported no other significant conflicts of interest to disclose.

 

SOURCE: Kasivisvanathan V et al. N Engl J Med. 2018 Mar 19. doi: 10.1056/NEJMoa1801993.