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INTRODUCTION/BACKGROUND: Only 1 randomized controlled trial has compared focal therapy and active surveillance (AS) for the low-risk prostate cancer (PCa). We investigated whether focal HIFU (fHIFU) yields oncologic advantages over AS for low-risk PCa. MATERIALS AND METHODS: We included 2 non-randomized prospective series of 132 (fHIFU) and 421 (AS) consecutive patients diagnosed with ISUP 1 PCa between 2008 and 2018. A matched pair analysis was performed to decrease potential bias. Study main outcomes were freedom from radical treatment (RT) or androgen-deprivation therapy (ADT), treatment-free survival (TFS), time to metastasis, and overall survival (OS). RESULTS: Median fHIFU follow-up was 50 months (interquartile range, 29-84 months). Among matched variables, no major differences were recorded except for AS having more suspicious digital rectal examination findings (P = .0074) and recent enrollment year (P = .0005). Five-year intervention-free survival from RT or ADT was higher for the fHIFU cohort (67.4% vs. 53.8%; P = .0158). Time to treatment was approximately 10 months shorter for AS than for fHIFU (time to RT, P = .0363; time to RT or ADT, P = .0156; time to any treatment, P = .0319). No differences were found in any-TFS (fHIFU, 61.4% vs. AS, 53.8%; P = .2635), OS (fHIFU, 97% vs. AS, 97%; P = .9237), or metastasis (n = 0 in fHIFU and n = 2 in AS; P = .4981). Major complications (≥ Clavien 3) were rare (n = 4), although 36.4% of men experienced complications. No relevant changes were noted in continence (P = .3949). CONCLUSION: At a 4-year median follow-up, fHIFU for mainly low-risk PCa (ISUP grade 1) is safe, may decrease the need for radical treatment or ADT and may allow longer time to treatment compared to AS. Nonetheless, no advantages are seen in PCa progression and/or death (OS).
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Antagonistas de Andrógenos , Neoplasias de la Próstata , Masculino , Humanos , Neoplasias de la Próstata/patología , Análisis por Apareamiento , Espera Vigilante , Estudios Prospectivos , Resultado del TratamientoRESUMEN
CONTEXT: Prebiopsy multiparametric magnetic resonance imaging (mpMRI) is increasingly used in prostate cancer diagnosis. The reported negative predictive value (NPV) of mpMRI is used by some clinicians to aid in decision making about whether or not to proceed to biopsy. OBJECTIVE: We aim to perform a contemporary systematic review that reflects the latest literature on optimal mpMRI techniques and scoring systems to update the NPV of mpMRI for clinically significant prostate cancer (csPCa). EVIDENCE ACQUISITION: We conducted a systematic literature search and included studies from 2016 to September 4, 2019, which assessed the NPV of mpMRI for csPCa, using biopsy or clinical follow-up as the reference standard. To ensure that studies included in this analysis reflect contemporary practice, we only included studies in which mpMRI findings were interpreted according to the Prostate Imaging Reporting and Data System (PIRADS) or similar Likert grading system. We define negative mpMRI as either (1) PIRADS/Likert 1-2 or (2) PIRADS/Likert 1-3; csPCa was defined as either (1) Gleason grade group ≥2 or (2) Gleason grade group ≥3. We calculated NPV separately for each combination of negative mpMRI and csPCa. EVIDENCE SYNTHESIS: A total of 42 studies with 7321 patients met our inclusion criteria and were included for analysis. Using definition (1) for negative mpMRI and csPCa, the pooled NPV for biopsy-naïve men was 90.8% (95% confidence interval [CI] 88.1-93.1%). When defining csPCa using definition (2), the NPV for csPCa was 97.1% (95% CI 94.9-98.7%). Calculation of the pooled NPV using definition (2) for negative mpMRI and definition (1) for csPCa yielded the following: 86.8% (95% CI 80.1-92.4%). Using definition (2) for both negative mpMRI and csPCa, the pooled NPV from two studies was 96.1% (95% CI 93.4-98.2%). CONCLUSIONS: Multiparametric MRI of the prostate is generally an accurate test for ruling out csPCa. However, we observed heterogeneity in the NPV estimates, and local institutional data should form the basis of decision making if available. PATIENT SUMMARY: The negative predictive values should assist in decision making for clinicians considering not proceeding to biopsy in men with elevated age-specific prostate-specific antigen and multiparametric magnetic resonance imaging reported as negative (or equivocal) on Prostate Imaging Reporting and Data System/Likert scoring. Some 7-10% of men, depending on the setting, will miss a diagnosis of clinically significant cancer if they do not proceed to biopsy. Given the institutional variation in results, it is of upmost importance to base decision making on local data if available.
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Imágenes de Resonancia Magnética Multiparamétrica , Neoplasias de la Próstata/diagnóstico por imagen , Sistemas de Datos , Humanos , Masculino , Valor Predictivo de las Pruebas , Proyectos de InvestigaciónRESUMEN
OBJECTIVES: Prostate biopsy (PB) is the gold standard for the diagnosis of prostate cancer (PCa). However, the optimal number of biopsy cores remains debatable. We sought to compare contemporary standard (10-12 cores) vs. saturation (≥18 cores) schemes on initial as well as repeat PB. METHODS: A non-systematic review of the literature was performed from 2000 through 2013. Studies of highest evidence (randomized controlled trials, prospective non-randomized studies, and retrospective reports of high quality) comparing standard vs saturation schemes on initial and repeat PB were evaluated. Outcome measures were overall PCa detection rate, detection rate of insignificant PCa, and procedure-associated morbidity. RESULTS: On initial PB, there is growing evidence that a saturation scheme is associated with a higher PCa detection rate compared to a standard one in men with lower PSA levels (40 cc), or lower PSA density values lower PSA density values (<0.25 ng/ml/cc). However, these cutaffs are not uniform and differ among studies. Detection rates of insignificant PCa do not differ in a significant fashion between standard and saturation biopsies. On repeat PB, PCa detection rate is likewise higher with saturation protocols. Estimates of insignificant PCa vary widely due to differing definitions of insignificant disease. However, the rates of insignificant PCa appear to be comparable for the chemes in patients with only one prior negative biopsy, while saturation biopsy seems to detect more cases of insignificant PCa compared to standard biopsy in men with two or more prior negative biopsies. Very extensive sampling is associated with a high rate of acute urinary retention, whereas other severe adverse events, such as sepsis, appear not to occur more frequently with saturation schemes. DISCUSSION: Current evidence suggests that saturation schemes are associated with a higher PCas detection rate compared to standard ones oninitial PB inmen with lower PSA levels or larger prostates, and on repeat PB. Since most data are derived from retrospective studies, other endpoints such as detection rate of insignificant disease - especially on repeat PB - show broad variations throughout the literature and must, thus, be interpreted with caution. Future prospective controlled trials should be conducted to compare extended templates with newer techniques, such as image-guided sampling, in order to optimize PCa diagnostic strategy
OBJECTIVE: La biopsia de próstata (BP) es el patrón oro para el diagnóstico de cáncer de próstata (CaP). Sin embargo, el número óptimo de muestras de la biopsia continua en debate. Comparamos los esquemas de biopsia estándar contemporánea (10-12 muestras) y de saturación (≥18 muestras) tanto en biopsia inicial como en biopsias repetidas. MÉTODOS: Realizamos una revisión no sistemática de la literatura desde el año 2000 al 2013. Evaluamos los estudios comparativos entre el esquemas estándar y la saturación, tanto en BP iniciales como repetidas, con mayor evidencia (Ensayos clínicos aleatorizados, estudios prospectivos no aleatorizados y comunicaciones retrospectivas de alta calidad). Las medidas de resultados fueron tasa de detección global de CaP, detección de CaP insignificante y morbilidad asociada con el procedimiento. RESULTADOS: En biopsia inicial, hay un aumento de la evidencia de que el esquema de saturación se asocia con una tasa de detección de CaP mayor en comparación con el estándar en varones con valores de PSA menores(40 cc), o valores de densidad del PSA menores (<0.25 ng/ml/cc). Sin embargo, estos valores de corte no son uniformes y difieren entre los estudios. Las tasas de detección de CaP insignificante no difieren de manera significativa entre las biopsias estándar y de saturación. En BP repetidas, la tasa de detección de CaP es igualmente más alta con los protocolos de saturación. Las estimaciones de CaP insignificante varían ampliamente debido a diferentes definiciones de la enfermedad insignificante. Sin embargo, las tasas de CaP insignificante parecen ser comparables entre ambos esquemas en pacientes con sólo una biopsia previa negativa, mientras que la biopsia por saturación parece detectar más casos de CaP insignificante en comparación con la estándar en varones con dos o más biopsias previas negativas. Un número de muestras muy amplio se asocia con una tasa alta de retención urinaria aguda, mientras que otros eventos adversos graves, como sepsis, no parece que aparezcan más frecuentemente con los esquemas de saturación. DISCUSSION: La evidencia actual sugiere que los esquemas de saturación se asocian con mayores tasas de detección de CaP en comparación con los estándar en BP inicial en varones con niveles de PSA menores o próstatas más grandes, y en biopsias repetidas. Puesto que la mayorías de los datos provienen de estudios retrospectivos, otras variables de resultados como la tasa de detección de enfermedad insignificante- especialmente en BP repetidas- muestran amplias variaciones en la literatura y , por lo tanto deben ser interpretadas con precaución. Deberían llevarse a cabo futuros ensayos prospectivos controlados para comparar plantillas extendidas con nuevas técnicas, tales cómo toma de muestras guiada por la imagen, para optimizar la estrategia de diagnóstico del CaP
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Humanos , Masculino , Neoplasias de la Próstata/diagnóstico , Biopsia/métodos , Biopsia , Ultrasonido Enfocado Transrectal de Alta Intensidad , Estudios Prospectivos , Estudios Retrospectivos , MorbilidadRESUMEN
INTRODUCTION: Prostate needle-biopsies are among the most common specimens in routine histopathological practice; in 15% colorectal tissue is also present. Rectal pathology is described to be found in 17% of this coincidentally obtained material. CASE PRESENTATION: We present a case in which colorectal carcinoid was found in the rectal mucosa obtained via transrectal prostate biopsies in a screening program for prostate cancer in a 71-year old Caucasian male. To the best of our knowledge, this was the first time that such a coincidental finding was discovered. Besides a colonoscopy with polypectomy, this coincidental detection remained without any further clinical consequences for this patient until today. CONCLUSION: As there is a considerable chance that abnormalities are found in the rectal tissue of prostate biopsies, it is advisable for all pathologists to include this tissue in the histology evaluation and look for potential irregularities in this simultaneously collected material.