📃 Paper Title: MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis
🧍 Author: Kasivisvanathan
🕒 Year: 2018
📚 Journal: NEJM
🌎 Country: UK
ㅤContext to the study:
Can you tell me about multiparametric MRI with targeted biopsy for detecting prostate cancer in biopsy naive patients?
ㅤ✅ Take-home message of study:
The study evaluated whether multiparametric MRI, with targeted biopsy in the presence of an abnormal lesion, was non-inferior to conventional transrectal ultrasound-guided biopsy in the detection of clinically significant prostate cancer in biopsy naive patients.
It found that the use of risk assessment with MRI before biopsy and MRI-targeted biopsy was superior to standard transrectal ultrasonagraphy-guided biopsy in men at clinical risk for prostate cancer who had not undergone biopsy previously
ㅤ Multi-center, randomized non-inferiority prospective trial
ㅤ
Study participants:
Number included: 500 participants
Randomized at 23 sites, with 252 participants assigned to MRI-targeted biopsy group and 248 to the standard-biopsy group.
Inclusion Criteria
Participants had not undergone a prostate biopsy previously
Men were referred with a clinical suspicion of prostate cancer on the basis of an elevated PSA and/or abnormal DRE
Suitable candidate for biopsy of the prostate and for MRI imaging
ㅤ
ㅤ
Key study outcomes:
Primary Outcome:
The proportion of men with clinically significant prostate cancer:
Clinically significant cancer was detected in 95 men (38%) in the MRI-targeted biopsy group, compared with 64 men (26%) in the standard-biopsy group (adjusted difference, 12 percentage points, 95% confidence interval 4 to 20; p=0.005)
Secondary Outcome(s):
The proportion of men with clinically insignificant prostate cancer:
Clinically insignificant cancer was detected in 23 men (9%) in the MRI-targeted biopsy group, compared with 55 men (22%) in the standard-biopsy group (adjusted difference, -13 percentage points, 95% confidence interval -19 to -7; p<0.001).
ㅤ
ㅤ
Study Limitations:
Variations in reporting of multiparametric MRIs between centres
Small proportion of pathological test results were upgraded or downgraded
Men with a negative result on multiparametric MRI who do not undergo a biopsy as per the protocol may still have clinically significant prostate cancer according to the literature
Clinically significant cancers may have been missed by the omission of standard biopsy cores in men in the MRI-targeted biopsy group
ㅤ