AbstractObjectiveTo evaluate the diagnostic performance of multiparametric MRI (mpMRI), mpMRI combined with PSA density (PSAd) and combined biopsy (CBx) in detecting clinically significant prostate cancer (csPCa) in men undergoing active surveillance, using radical prostatectomy (RP) specimens as the reference standard.Patients and MethodsIn this prospective single‐centre study, 91 patients with low‐risk prostate cancer under active surveillance underwent mpMRI, PSAd measurement, CBx and ultimately RP. mpMRI was reported using PI‐RADS v2.0, and PSAd was dichotomised at 0.12 ng/ml/cm3. Diagnostic accuracy was compared using ISUP grade ≥2 and ≥3 thresholds. Radical prostatectomy pathology served as the reference standard.ResultsFor detecting ISUP ≥3 cancer, mpMRI combined with PSAd achieved the highest sensitivity (93.3%) and negative predictive value (94.4%). CBx demonstrated the highest specificity (88.2%) and overall diagnostic balance (Youden index = 0.348). mpMRI alone showed intermediate performance. Differences in classification between strategies were statistically significant (McNemar p < 0.001).ConclusionsmpMRI combined with PSAd provides high sensitivity and negative predictive value for ruling out aggressive prostate cancer, supporting its use as a non‐invasive triage tool in active surveillance. CBx remains the most specific method for histological confirmation. These strategies should be used complementarily to optimise decision‐making in active surveillance protocols.
Biparametric vs Multiparametric MRI for Prostate Cancer Diagnosis
Importance Multiparametric magnetic resonance imaging (MRI), with or without prostate biopsy, has become the standard of care for diagnosing clinically significant prostate cancer. Resource capacity limits widespread adoption. Biparametric MRI, which omits the gadolinium contrast sequence, is a shorter and cheaper alternative offering time-saving capacity gains for health systems globally. Objective To assess whether biparametric MRI is noninferior to multiparametric MRI for diagnosis of clinically significant prostate cancer. Design, Setting, and Participants A prospective, multicenter, within-patient, noninferiority trial of biopsy-naive men from 22 centers (12 countries) with clinical suspicion of prostate cancer (elevated prostate-specific antigen [PSA] level and/or abnormal digital rectal examination findings) from April 2022 to September 2023, with the last follow-up conducted on December 3, 2024. Interventions Participants underwent multiparametric MRI, comprising T2-weighted, diffusion-weighted, and dynamic contrast–enhanced (DCE) sequences. Radiologists reported abbreviated biparametric MRI first (T2-weighted and diffusion-weighted), blinded to the DCE sequence. After unblinding, radiologists reported the full multiparametric MRI. Patients underwent a targeted biopsy with or without systematic biopsy if either biparametric MRI or multiparametric MRI was suggestive of clinically significant prostate cancer. Main outcomes and measures The primary outcome was the proportion of men with clinically significant prostate cancer. Secondary outcomes included the proportion of men with clinically insignificant cancer. The noninferiority margin was 5%. Results Of 555 men recruited, 490 were included for primary outcome analysis. Median age was 65 (IQR, 59-70) years and median PSA level was 5.6 (IQR, 4.4-8.0) ng/mL. The proportion of patients with abnormal digital rectal examination findings was 12.7%. Biparametric MRI was noninferior to multiparametric MRI, detecting clinically significant prostate cancer in 143 of 490 men (29.2%), compared with 145 of 490 men (29.6%) (difference, −0.4 [95% CI, −1.2 to 0.4] percentage points; P = .50). Biparametric MRI detected clinically insignificant cancer in 45 of 490 men (9.2%), compared with 47 of 490 men (9.6%) with the use of multiparametric MRI (difference, −0.4 [95% CI, −1.2 to 0.4] percentage points). Central quality control demonstrated that 99% of scans were of adequate diagnostic quality. Conclusion and relevance In men with suspected prostate cancer, provided image quality is adequate, an abbreviated biparametric MRI scan, with or without targeted biopsy, could become the new standard of care for prostate cancer diagnosis. With approximately 4 million prostate MRIs performed globally annually, adopting biparametric MRI could substantially increase scanner throughput and reduce costs worldwide. Trial registration ClinicalTrials.gov Identifier: NCT04571840
Angiotomografia Computadorizada com Descarte Triplo Convencional e Parcialmente Sincronizada ao ECG com Cobertura da Aorta Abdominal: Comparação da Dose de Radiação e da Qualidade da Imagem
Fundamento: A angiotomografia computadorizada (ATC) com descarte triplo (TRO; do inglês, triple rule-out) é um protocolo sincronizado ao eletrocardiograma (ECG) que permite a avaliação simultânea das artérias coronárias, da aorta torácica e das artérias pulmonares em um único exame. É especialmente útil para pacientes com risco baixo a moderado de síndrome coronariana aguda no pronto atendimento, particularmente quando dissecção aórtica e embolia pulmonar também são consideradas no diagnóstico diferencial. Objetivo: O presente estudo visou comparar, em termos de dose de radiação e qualidade da imagem, dois protocolos de TRO: totalmente sincronizado ao ECG (protocolo A) e parcialmente sincronizado ao ECG (protocolo B), ambos incluindo cobertura da aorta abdominal. Tal comparação de protocolos pode ser útil quando algoritmos de reconstrução iterativa não estiverem disponíveis e a transição manual entre em protocolos parcialmente sincronizados ao ECG for necessária. Métodos: A dose de radiação foi avaliada usando o produto dose-comprimento, a dose efetiva e a dose virtual. Os valores de atenuação foram medidos nas artérias coronárias e pulmonares, bem como na aorta descendente e abdominal. A qualidade da imagem e a conspicuidade dos vasos foram avaliadas por meio de uma escala Likert de 5 pontos. Resultados: Um total de 56 pacientes foi incluído. O protocolo B demonstrou exposição à radiação significativamente menor em comparação ao protocolo A em todas as métricas: mediana do produto dose-comprimento (1,1 mSv [intervalo interquartil: 0,9 a 1,1] versus 2,2 mSv [intervalo interquartil: 1,6 a 2,8]), dose efetiva (17,0 mSv [intervalo interquartil: 14,3 a 18,1] versus 32,6 mSv [intervalo interquartil: 24,4 a 42,7]) e dose virtual (16,2 [intervalo interquartil: 9,3 a 20,4] versus 34,7 [intervalo interquartil: 19,9 a 43,5]). Todas as diferenças foram estatisticamente significativas (p < 0,001). Não houve diferenças significativas nas medidas de atenuação ou na avaliação qualitativa das imagens entre os dois protocolos. Conclusão: A ATC com TRO parcialmente sincronizada ao ECG proporciona qualidade de imagem comparável à técnica totalmente sincronizada ao ECG, reduzindo significativamente a exposição à radiação, tornando-se uma alternativa mais eficiente em termos de dose de radiação, quando algoritmos de reconstrução iterativa não estiverem disponíveis e a transição manual for necessária.