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PSA Screening Combined With MRI-Targeted Biopsy for Detecting Prostate Cancer
TAKE-HOME MESSAGE
- This population-based trial evaluated the outcomes of using PSA screening combined with MRI-targeted biopsy for detecting prostate cancer. It compared the detection rates of clinically insignificant and significant prostate cancers between two groups: patients who underwent a systematic biopsy and those who underwent a biopsy only when the MRI results were positive. Over a median follow-up of 3.9 years, the MRI-targeted biopsy group had significantly fewer diagnoses of clinically insignificant cancers (RR, 0.43; P < .001) while maintaining a low risk of missing clinically significant or advanced cancers (RR, 0.84).
- The results of this study indicate that the use of MRI-targeted biopsy in screening could reduce overdiagnosis and unnecessary treatment of prostate cancer.
abstract
This abstract is available on the publisher's site.
Access this abstract nowBACKGROUND
Data on the efficacy and safety of screening for prostate cancer with magnetic resonance imaging (MRI) are needed from studies of follow-up screening.
METHODS
In a population-based trial that started in 2015, we invited men who were 50 to 60 years of age to undergo prostate-specific antigen (PSA) screening. Men with a PSA level of 3 ng per milliliter or higher underwent MRI of the prostate. Men were randomly assigned to the systematic biopsy group, in which they underwent systematic biopsy and, if suspicious lesions were found on MRI, targeted biopsy, or the MRI-targeted biopsy group, in which they underwent MRI-targeted biopsy only. At each visit, men were invited for repeat screening 2, 4, or 8 years later, depending on the PSA level. The primary outcome was detection of clinically insignificant (International Society of Urological Pathology [ISUP] grade 1) prostate cancer; detection of clinically significant (ISUP grade ≥2) cancer was a secondary outcome, and detection of clinically advanced or high-risk (metastatic or ISUP grade 4 or 5) cancer was also assessed.
RESULTS
After a median follow-up of 3.9 years (approximately 26,000 person-years in each group), prostate cancer had been detected in 185 of the 6575 men (2.8%) in the MRI-targeted biopsy group and 298 of the 6578 men (4.5%) in the systematic biopsy group. The relative risk of detecting clinically insignificant cancer in the MRI-targeted biopsy group as compared with the systematic biopsy group was 0.43 (95% confidence interval [CI], 0.32 to 0.57; P<0.001) and was lower at repeat rounds of screening than in the first round (relative risk, 0.25 vs. 0.49); the relative risk of a diagnosis of clinically significant prostate cancer was 0.84 (95% CI, 0.66 to 1.07). The number of advanced or high-risk cancers detected (by screening or as interval cancer) was 15 in the MRI-targeted biopsy group and 23 in the systematic biopsy group (relative risk, 0.65; 95% CI, 0.34 to 1.24). Five severe adverse events occurred (three in the systematic biopsy group and two in the MRI-targeted biopsy group).
CONCLUSIONS
In this trial, omitting biopsy in patients with negative MRI results eliminated more than half of diagnoses of clinically insignificant prostate cancer, and the associated risk of having incurable cancer diagnosed at screening or as interval cancer was very low. (Funded by Karin and Christer Johansson's Foundation and others; GÖTEBORG-2 ISRCTN registry number, ISRCTN94604465.)
Additional Info
Disclosure statements are available on the authors' profiles:
Results after Four Years of Screening for Prostate Cancer with PSA and MRI
N. Engl. J. Med 2024 Sep 26;391(12)1083-1095, J Hugosson, RA Godtman, J Wallstrom, U Axcrona, A Bergh, L Egevad, K Geterud, A Khatami, A Socratous, V Spyratou, L Svensson, J Stranne, M Månsson, M HellstromFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
MRI for elevated PSA
In 2021, the European Association of Urology published a recommended approach that encouraged the use of an MRI evaluation to guide response to an elevated prostate-specific antigen (PSA; >3 ng/mL) level.
This current study tested this recommendation. The study randomized 38,316 men with a PSA level greater than 3 ng/mL to MRI followed by systematic biopsy regardless of MRI results or a targeted MRI group where a biopsy was only performed if there was a concerning lesion detected on MRI or if the PSA level was greater than 10 ng/mL.
MRI-targeted biopsy eliminated half the diagnosis of clinically insignificant prostate cancer and the associated costs, risks, and harm from the intervention. The risk of needing a prostate biopsy was reduced by 59% in the targeted MRI group. The authors concluded that most aggressive prostate cancers become visible on MRI before these cancers become incurable.
The clinical bottom line of this study and the recommendations from the European Association of Urology is to use MRI to further evaluate individuals with elevated PSA levels, particularly high-risk populations.
PSA assay is still an imperfect screening test, and shared decision–making should be used before it is ordered.