Prostate Cancer Screening with PSA and MRI Followed by Targeted Biopsy Only
Mené sur 17 980 hommes dont le niveau du PSA est supérieur ou égal à 3ng/ml (âge : de 50 à 60 ans), cet essai évalue l'efficacité, du point de vue du taux de détection de tumeurs avec score de Gleason 3+3 et du taux de détection de tumeurs avec score de Gleason 3+4 ou supérieur, et la sécurité d'une IRM de dépistage suivie, si présence de lésions suspectes, d'une biopsie ciblée
BACKGROUND : Screening for prostate cancer is burdened by a high rate of overdiagnosis. The most appropriate algorithm for population-based screening is unknown.
METHODS : We invited 37,887 men who were 50 to 60 years of age to undergo regular prostate-specific antigen (PSA) screening. Participants with a PSA level of 3 ng per milliliter or higher underwent magnetic resonance imaging (MRI) of the prostate; one third of the participants were randomly assigned to a reference group that underwent systematic biopsy as well as targeted biopsy of suspicious lesions shown on MRI. The remaining participants were assigned to the experimental group and underwent MRI-targeted biopsy only. The primary outcome was clinically insignificant prostate cancer, defined as a Gleason score of 3+3. The secondary outcome was clinically significant prostate cancer, defined as a Gleason score of at least 3+4. Safety was also assessed.
RESULTS : Of the men who were invited to undergo screening, 17,980 (47%) participated in the trial. A total of 66 of the 11,986 participants in the experimental group (0.6%) received a diagnosis of clinically insignificant prostate cancer, as compared with 72 of 5994 participants (1.2%) in the reference group, a difference of −0.7 percentage points (95% confidence interval [CI], −1.0 to −0.4; relative risk, 0.46; 95% CI, 0.33 to 0.64; P<0.001). The relative risk of clinically significant prostate cancer in the experimental group as compared with the reference group was 0.81 (95% CI, 0.60 to 1.1). Clinically significant cancer that was detected only by systematic biopsy was diagnosed in 10 participants in the reference group; all cases were of intermediate risk and involved mainly low-volume disease that was managed with active surveillance. Serious adverse events were rare (<0.1%) in the two groups.
CONCLUSIONS : The avoidance of systematic biopsy in favor of MRI-directed targeted biopsy for screening and early detection in persons with elevated PSA levels reduced the risk of overdiagnosis by half at the cost of delaying detection of intermediate-risk tumors in a small proportion of patients. (Funded by Karin and Christer Johansson’s Foundation and others; GÖTEBORG-2 ISRCTN Registry number, ISRCTN94604465. opens in new tab.)
New England Journal of Medicine , résumé, 2021