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PURPOSE: To compare the efficacy of a novel fusion template "reduced six-core systemic template and multiparametric magnetic resonance imaging/transrectal ultrasound (mpMRI/TRUS) fusion targeted biopsy" (TBx+6c), with mpMRI/TRUS fusion-targeted biopsy and 12-core systematic biopsy template (TBx+12c) in the diagnosis of prostate cancer (PCa). MATERIALS AND METHODS: This is an institutional review board approved single-center observational study involving adult men undergoing fusion-targeted biopsies for the diagnosis of PCa. Patients were sorted into cohorts of TBx+6c or TBx+12c based on the systematic biopsy template used. The study's main objective was to determine the cancer detection rate (CDR) for overall PCa and clinically significant PCa (csPCa) and the secondary objectives were to compare complication rates and functional outcome differences between the cohort. RESULTS: A total of 204 patients met study's inclusion criteria. TBx+6c group had 120 patients, while TBx+12c cohort had 84 patients. The groups had similar baseline characteristics and overall CDR in the TBx+6c cohort was 71.7% versus 79.8%, compared to the TBx+12c (p = 0.18) whereas, the csPCa detection rate in the TBx+6c group was 50.8% versus 54.8% in the TBx+12c group (p = 0.5). TBx+6c cohort had lower overall complication rate of 3% versus 13%, (p = 0.01) and ≥ grade 2 complication rates (1 (1%) vs. 3(4%), p = 0.03) compared to the TBx+12c cohort. There were no differences in IIEF-5 (p = 0.5) or IPSS (p = 0.1) scores at baseline and 2-weeks and 6-weeks post-biopsy. CONCLUSION: TBx+6c cohort, when compared to the TBx+12c cohort, demonstrated comparable diagnostic performance along with similar functional outcomes and lower complication rates. These results suggest the importance of further exploring the clinical implications of adopting a TBx+6c schema for PCa diagnosis in comparison to the widely used TBx+12c schema through a multicenter randomized controlled trial.
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Biopsia Guiada por Imagen , Imágenes de Resonancia Magnética Multiparamétrica , Neoplasias de la Próstata , Humanos , Masculino , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/diagnóstico por imagen , Biopsia Guiada por Imagen/métodos , Biopsia Guiada por Imagen/efectos adversos , Persona de Mediana Edad , Anciano , Imágenes de Resonancia Magnética Multiparamétrica/métodos , Ultrasonografía Intervencional/métodos , Próstata/patología , Próstata/diagnóstico por imagenRESUMEN
BACKGROUND: Salvage cryotherapy (SCT) is widely used to treat prostate cancer (PCa) recurrence after radiotherapy (RT). We studied the intermediate oncological and functional outcomes of patients who underwent SCT following cryotherapy (CRYO-SCT) recurrence and compare it to recurrence after brachytherapy (BT-SCT). METHODS: An IRB-approved retrospective cohort study utilizing patient data from the Cryo On-Line Data Registry and the Duke PCa database between 1992 and 2016. Biochemical recurrence (BCR) using Phoenix criteria was the primary endpoint assessed at 2- and 5-years post-SCT. Secondary endpoints assessed functional outcomes including urinary continence, erectile function, and recto-urethral fistula. Association between treatment and biochemical progression-free survival was assessed using inverse probability weighted (IPTW) Cox proportional hazards regression. The differences in the secondary functional outcomes were assessed by Pearson's χ2 test or Fisher's exact test, corrected for IPTW. RESULTS: A total of 194 patients met inclusion criteria. The BCR rate for BT-SCT and CRYO-SCT was 23 (20.4%) and 17 (21%) at 2 years and 30 (26.5%) and 22 (27.2%) at 5 years according to Phoenix criteria. There was no statistical difference in 2 years (hazard ratio [HR] 0.9; 95% confidence interval [CI], 0.5-1.7, p = 0.7) or 5-year BCR (HR: 0.86; 95% CI, 0.5-1.5, p = 0.6) between the groups. The functional outcomes like urinary continence (p = 0.4), erectile function (p = 0.1), and recto-urethral fistula (p = 0.3) were not statistically different. CONCLUSION: CRYO-SCT appears to be well tolerated, with comparable oncological and functional outcomes to patients failing primary BT. The findings also demonstrated that SCT can render a significant number of patients biochemically free of disease after initial CRYO with minimal morbidity. SCT is a viable treatment option to salvage local PCa recurrence following either BT or cryoablation failure.
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Braquiterapia , Disfunción Eréctil , Fístula , Neoplasias de la Próstata , Masculino , Humanos , Braquiterapia/efectos adversos , Disfunción Eréctil/etiología , Antígeno Prostático Específico , Estudios Retrospectivos , Puntaje de Propensión , Recurrencia Local de Neoplasia/radioterapia , Recurrencia Local de Neoplasia/cirugía , Neoplasias de la Próstata/radioterapia , Neoplasias de la Próstata/cirugía , Crioterapia/efectos adversos , Fístula/etiología , Fístula/terapia , Terapia Recuperativa , Resultado del TratamientoRESUMEN
INTRODUCTION: The clinical utility of concurrent Prostate Health Index (PHI) and ExosomeDx Prostate Intelliscore (EPI) testing is unclear. We sought to examine the performance of combined PHI and EPI testing on men undergoing elevated PSA work up. MATERIALS AND METHODS: Patients who received both EPI and PHI testing were identified from an institutional database of men referred to urology for an elevated total PSA. Cut points of EPI > 15.6 and PHI ≥ 36 were used to denote a positive test. Patients were placed into one of four groups determined by combination of EPI and PHI results. Demographic variables and biopsy recommendations were compared between groups. The concordance of test positivity between EPI and PHI was compared by Cohen's kappa. Demographic variables and secondary testing results were compared between patients' compliant and non-compliant with prostate biopsy recommendation. Biopsy pathology was compared between groups. RESULTS: A total of 162 patients had both EPI and PHI testing. Median age was 65 years, with a median PSA of 6.64 ng/mL. Age (p = 0.001), PSA (< 0.001) and biopsy recommendation (< 0.001) differed between combined secondary screening test result groups. Seventy-five percent of patients with both a positive EPI and PHI were found to have prostate cancer, with 54.2% being ≥ Gleason 7. Cohen's kappa was 0.19, indicating poor concordance. The AUC of EPI and PHI for clinically significant cancer was 0.563 (95% CI: 0.4331-0.6923) and 0.685 (95% CI: 0.569-0.8) (p = 0.147). CONCLUSIONS: Concurrently positive EPI and PHI indicate increased prostate cancer risk, with combined usage potentially influencing biopsy recommendation and compliance.
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Detección Precoz del Cáncer , Neoplasias de la Próstata , Anciano , Humanos , Masculino , Biopsia , Detección Precoz del Cáncer/métodos , Estudios Prospectivos , Próstata/patología , Antígeno Prostático Específico , Neoplasias de la Próstata/diagnóstico , Neoplasias de la Próstata/patologíaRESUMEN
BACKGROUND: This study reports the oncological and functional outcomes in men with localized prostate cancer (Pca) who were treated with primary whole gland cryoablation (WGC) of the prostate. METHODS: The authors retrospectively reviewed their prospectively collected cryosurgery database between January 2002 and September 2019 for men who were treated with WGC of the prostate at a tertiary referral center. Primary outcome includes biochemical recurrence-free survival (BRFS). Secondary outcomes include failure-free survival (FFS), metastasis-free survival (MFS) and adverse events. RESULTS: A total of 260 men were included in the study. Men having had prior treatment for Pca were excluded. Median follow-up was 107 months (interquartile range [IQR], 68.3-132.5 months). BRFS, FFS, and MFS at 10 years were 84%, 66%, and 96%, respectively. High risk D'Amico classification was associated with a lower BRFS and FFS on multivariable analysis. No patient had any Pca-related death during follow-up. American Urological Association symptoms score and bother index were unchanged following cryoablation. Median International Index of Erectile Function score precryoablation and post-cryoablation was 7 (IQR, 3-11) and 1 (IQR, 1-5), respectively. Stress urinary incontinence, defined as requiring any protective pads only occurred in five patients (2%). No patient developed a fistula. Grade > 2 Clavien-Dindo adverse events occurred in six (2.3%) patients. CONCLUSION: WGC of the prostate can achieve excellent oncological and functional outcomes in men with localized Pca at the 10-year mark. Primary WGC may be a good option for men who desire to preserve urinary continence and have an excellent oncologic outcome. LAY SUMMARY: Primary whole gland cryoablation is an alternative treatment option to radical prostatectomy and radiotherapy for men with organ-confined prostate cancer. Patients had excellent cancer outcomes 1 years after whole gland cryoablation, and patients with PSA nadir 0.1 ng/ml or lower after treatment were less likely to have disease recurrence.
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Criocirugía , Neoplasias de la Próstata , Criocirugía/efectos adversos , Humanos , Masculino , Recurrencia Local de Neoplasia/diagnóstico , Próstata/cirugía , Antígeno Prostático Específico , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
PURPOSE OF REVIEW: To review assessment after focal therapy (FT) in the context of developments from the past two years. RECENT FINDINGS: With a paucity of high-quality studies, recent findings are primarily reliant on results from institutional-based cohorts and reports of expert consensus. Notably, oncologic treatment failure should be further stratified into recurrence in the in-field or out-of-field ablation zone, and both regions should be surveilled postoperatively. Monitoring primarily consists of periodic evaluations of prostate-specific antigen (PSA) testing and magnetic resonance imaging, with histologic sampling needed to confirm suspicion of recurrence. Recent investigations into PSA derivatives, contrast-enhanced ultrasound, and prostate-specific membrane antigen imaging have shown preliminary promise. Although postablation functional outcomes are generally accepted to be excellent, they are limited by the wide range of patient-reported measures, variability in individual practice, and low questionnaire completion rates. SUMMARY: There is still a need for high-level, long-term data to inform exact standardized protocols to manage patients after FT. A multifaceted approach is required to surveil patients and identify those at risk of recurrence. Embracing shared responsibility between the patient and clinician to fastidiously monitor the infield and out-of-field ablation zones postoperatively is critical to maximize oncologic outcomes.
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Antígeno Prostático Específico , Neoplasias de la Próstata , Humanos , Imagen por Resonancia Magnética , Masculino , Prostatectomía/métodos , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/cirugía , Insuficiencia del TratamientoRESUMEN
OBJECTIVE: To determine whether heterogeneity of tumor grade affects the response to Bacillus Calmette-Guérin (BCG) treatment for patients with non-muscle-invasive bladder cancer (NMIBC). METHODS: Patients with Ta or T1 NMBIC receiving a 6-week induction course of intravesical BCG therapy after transurethral resection were divided according to the tumor grade. Clinical and pathological variables were compared. Advanced intervention-free survival (AIFS), defined as duration of freedom from advanced intervention (including non-BCG intravesical agents or cystectomy) or metastasis, was plotted using Kaplan-Meier methods. The effect of grade on survival duration was assessed by multivariate Cox proportional hazards modeling. RESULTS: One hundred and fifty-three patients were identified: 17 with mixed low- and high-grade (MG) and 136 with pure high-grade (PHG) NMIBC. Demographic and additional pathologic variables were comparable between groups (p > 0.05). Five-year AIFS was 88.2% for MG patients, compared to 48.5% for PHG patients (p = 0.030 by log-rank test). On multivariate analysis, PHG was an independent risk factor for worse AIFS (HR 4.4, 95% CI 1.1-18.4, p = 0.040). Among patients failing to respond to primary BCG induction, who underwent a secondary induction of BCG with interferon, MG patients had better response than PHG patients (100 vs. 26.3%, p = 0.035). CONCLUSIONS: Mixed low- and high-grade NMIBC exhibits a significantly better response profile to intravesical BCG therapy compared to PHG NMIBC. The implications of these results are that less aggressive treatment strategies for this unique cancer entity may be needed and that there is a benefit to the reporting of tumor heterogeneity in transurethral resection of bladder tumor specimens.
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Adyuvantes Inmunológicos/uso terapéutico , Vacuna BCG/uso terapéutico , Carcinoma de Células Transicionales/terapia , Cistectomía , Músculo Liso/patología , Neoplasias de la Vejiga Urinaria/terapia , Vejiga Urinaria/patología , Administración Intravesical , Adulto , Anciano , Anciano de 80 o más Años , Carcinoma de Células Transicionales/patología , Estudios de Cohortes , Supervivencia sin Enfermedad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Clasificación del Tumor , Invasividad Neoplásica , Pronóstico , Estudios Retrospectivos , Resultado del Tratamiento , Vejiga Urinaria/cirugía , Neoplasias de la Vejiga Urinaria/patologíaRESUMEN
Major advances have been made in the use of immunotherapy for the treatment of solid tumours, including the use of intratumourally injected immunotherapy instead of systemically delivered immunotherapy. The success of immunotherapy in prostate cancer treatment has been limited to specific populations with advanced disease, which is thought to be a result of prostate cancer being an immunologically 'cold' cancer. Accordingly, combining intratumoural immunotherapy with other treatments that would increase the immunological heat of prostate cancer is of interest. Thermal ablation therapy is currently one of the main strategies used for the treatment of localized prostate cancer and it causes immunological activation against prostate tissue. The use of intratumoural immunotherapy as an adjunct to thermal ablation offers the potential to elicit a systemic and lasting adaptive immune response to cancer-specific antigens, leading to a synergistic effect of combination therapy. The combination of thermal ablation and immunotherapy is currently in the early stages of investigation for the treatment of multiple solid tumour types, and the potential for this combination therapy to also offer benefit to prostate cancer patients is exciting.
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Inmunoterapia , Neoplasias de la Próstata , Masculino , Humanos , Neoplasias de la Próstata/terapia , Inmunoterapia/métodos , Terapia Combinada , Técnicas de Ablación/métodosRESUMEN
IMPORTANCE AND OBJECTIVE: Partial gland ablation (PGA) is increasingly popular as a treatment for men with intermediate-risk prostate cancer (IR-PCa) to preserve functional outcomes while controlling their cancer. We aimed to determine the impact of race and clinical characteristics on the risk of upstaging (≥pT2c) and having adverse pathological outcomes including seminal vesicle invasion (SVI), extra prostatic extension (EPE) and lymph node invasion (LNI) at radical prostatectomy (RP) among men with IR disease eligible for PGA with hemi-ablation (HA). DESIGN: Retrospective analysis. SETTING: Multicenter. PARTICIPANTS AND MEASURES: We studied patients diagnosed with unilateral IR-PCa treated with RP between 1988 and 2020 at 9 different Veterans Affairs hospitals within the SEARCH cohort. We analyzed differences in clinicopathological characteristics and outcome variables (odds of ≥pT2c and SVI, EPE and LNI) by race using multivariable logistic regression after adjusting for covariates. RESULTS: Among 3127 patients, 33% were African American (AA) men with unilateral IR-PCa undergoing RP. Compared to non-AA men, AA individuals were younger (61 vs. 65 years, p < 0.001), presented with a higher prostate specific antigen (PSA) category (≥10 ng/ml; 34 vs. 26%, p < 0.001), and had a lower clinical stage (p < 0.001). Among the 2,798 (89.5%) with ≥pT2c stage, AA men exhibited higher ≥ pT2c rates (93 vs. 89%, p < 0.001), primarily due to increased pT2c staging (64 vs. 57%), where upstaging beyond pT2 was lower than non-AA men (29 vs. 32%). On multivariable analysis, AA men were found to have higher odds of ≥pT2c (odds ratio [OR]: 1.39 CI, 1.02-1.88, p = 0.04), lower odds of EPE (OR: 0.73 CI, 0.58-0.91, p < 0.01) and no statistically significant associations with LNI (OR: 0.79 CI, 0.42-1.46, p = 0.45) and SVI (OR: 1 CI, 0.74-1.35, p = 0.99) compared to non-AA men. On multivariable analysis, clinical features associated with higher odds of ≥pT2c were pre-operative PSA ≥ 15 (OR = 2.07, P = 0.01) and higher number of positive cores (HPC) on biopsy (OR = 1.36, P < 0.001). Similarly, PSA ≥ 15, Gleason grade ≥3 and HPC on biopsy were associated with higher odds of SVI, EPE and LNI, respectively. CONCLUSIONS: In men with IR-PCa undergoing RP, AA men demonstrated an overall higher likelihood of ≥pT2c with lower upstaging beyond pT2, lower likelihood of EPE and no significant difference in likelihood of SVI and LNI compared to non-AA men. These findings support select AA men to be potential candidates for PGA, such as HA. Clinical factors are predictive of higher pathological stage and adverse pathological outcomes at RP and could be considered when selecting candidates for PGA.
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Objective: To perform a comprehensive review of the contemporary literature regarding both functional and oncologic outcomes after primary focal cryotherapy for prostate cancer (PCa), providing these results as a foundation for discussing recent developments in the realm of focal therapy. Background: Traditional treatments for PCa are often associated with debilitating functional side effects for patients. Due to advances in imaging and biopsy strategies, focal ablative therapies recently have garnered much interest and offer an alternative primary treatment for PCa patients with localized disease. Focal cryoablation utilizes heat extraction from tissues to generate an iceball and cause tissue destruction while sparing uninvolved prostatic regions. Optimized patient selection and postoperative management continue to be areas of interest and study as the field continues to develop. Methods: A search was performed of the PubMed and Embase databases to identify articles pertaining to primary focal PCa cryoablation since our group's last comprehensive review in 2016. Conclusions: Primary focal cryoablation for PCa offers optimized functional outcomes and a favorable adverse event profile. True evaluation of oncologic outcomes is hampered by lack of long-term follow-up and highly variable clinical endpoints across these studies. Nonetheless, outcomes appear adequate in the short- to medium-term time frame. Utilization of focal cryoablation is expected to grow with continued refinement of patient selection and management options in cases of treatment failure.
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OBJECTIVE: To assess how the validated Prostate Health Index (PHI) risk stratifications perform with African American (AA) men and establish a threshold PHI value to potentially rule out the need for prostate biopsy. MATERIALS AND METHODS: AA men meeting FDA-specified indications for PHI testing (>50 years old, PSA 4-10 and negative DRE) who underwent subsequent biopsy were included. Rates of clinically significant prostate cancer (csPCa, as defined by Gleason score ≥7) across accepted PHI stratifications were recorded. Receiver operator curve (ROC) analysis was undertaken to assess PHI performance to predict csPCa. A phi cutoff providing 90% sensitivity was identified. Among AA men with PSA 4-10 ng/mL, the proportion of men who proceeded to biopsy upon physician recommendation was determined. RESULTS: Two hundred nine patients met primary criteria; 91 (43.5%) of which had csPCA. The area under the curve for PHI predicting csPCa was 0.68 (95% CI: 0.61-0.75). Using a phi threshold of <23.0 to avoid biopsy provided 98.9% sensitivity, 9.3% specificity, and would have avoided 4.7% of biopsies. The proportion of those who proceeded to biopsy upon physician recommendation was 81.8%. CONCLUSIONS: PHI demonstrated limited performance in our cohort, with current stratifications featuring misleadingly low cancer detection rates for these men. Furthermore, PHI had limited use to avoid prostate biopsy, as the proposed threshold of 23.0 only allowed 4.7% of men to avoid biopsy. Further work is needed to assess and optimize PHI usage in AA men; nonetheless, it may still have use in increasing compliance with biopsy recommendation.
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Antígeno Prostático Específico , Neoplasias de la Próstata , Masculino , Humanos , Persona de Mediana Edad , Próstata/patología , Negro o Afroamericano , Neoplasias de la Próstata/diagnóstico , Neoplasias de la Próstata/patología , BiopsiaRESUMEN
OBJECTIVE: To assess Duke's experience on the utility of transperineal template mapping biopsy (TTMB) for re-evaluating patients with persistently elevated prostate-specific antigen after prior negative biopsy, with pre-existing prostate cancer (PCa) already on active surveillance (AS), or considering focal therapy (FT). METHODS: We retrospectively reviewed Duke patients undergoing TTMB. Functional outcomes were evaluated using International Index of Erectile Function-5 (IIEF-5) and International Prostate Symptom Score (IPSS). Complications within 30 days were recorded. Nonparametric statistical analyses compared functional measures from baseline to 2 and 6 weeks post-TTMB. RESULTS: From 8/2009 to 1/2021, 218 patients underwent TTMB, with 57-month median follow-up. Complication rate was 17.4%, with the majority Clavien I. Overall PCa detection was 72.9%, with clinically significant PCa in 53.2%; for those without prior PCa diagnosis (n = 117), overall detection was 64.1% with clinically significant PCa in 49.5%. Of those on AS at TTMB (n = 86), 36 (41.8%) had Gleason upgrading. TTMB changed management for 59 (68.6%) patients, with 38 (44.2%) proceeding to whole-gland therapy and 21 (24.4%) electing FT. Regarding functional outcomes, IPSS were insignificantly different from baseline at 6 weeks (P = NS). Overall functional score impacts were minimal across subgroups; in groups with significant declines in IIEF-5, median score drops were ≤1 point and caused minimal/no movement in IIEF-5 scoring category. CONCLUSION: In this cohort, TTMB offered enhanced cancer detection with overall minimal impact to functional outcomes. We conclude from this comprehensive assessment that TTMB provides value to rule out PCa, prevent overtreatment of those that can remain on AS, evaluate FT candidacy, and identify those needing whole-gland management.
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Próstata , Neoplasias de la Próstata , Masculino , Humanos , Próstata/patología , Estudios Retrospectivos , Biopsia , Neoplasias de la Próstata/patología , Proyectos de Investigación , Biopsia Guiada por ImagenRESUMEN
BACKGROUND: There is no consensus on the optimal approach for salvage local therapy in radiation-resistant/recurrent prostate cancer (RRPC). OBJECTIVE: To investigate oncological and functional outcomes for men treated with salvage whole-gland cryoablation (SWGC) of the prostate for RRPC. DESIGN, SETTING, AND PARTICIPANTS: We retrospectively reviewed our prospectively collected cryosurgery database between January 2002 and September 2019 for men who were treated with SWGC of the prostate at a tertiary referral center. INTERVENTION: SWGC of the prostate. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was biochemical recurrence-free survival (BRFS) according to the Phoenix criterion. Secondary outcomes included metastasis-free survival, cancer-specific survival, and adverse events. RESULTS AND LIMITATIONS: A total of 110 men with biopsy-proven RRPC were included in the study. Median follow-up for patients without biochemical recurrence (BCR) after SWGC was 71 mo (interquartile range [IQR] 42.3-116). BRFS was 81% at 2 yr and 71% at 5 yr. A higher prostate-specific antigen (PSA) nadir after SWGC was associated with worse BRFS. The median International Index of Erectile Function-5 score was 5 (IQR 1-15.5) before SWGC and 1 (IQR 1-4) after SWGC. Stress urinary incontinence, strictly defined as the use of any pads after treatment, was 5% at 3 mo and 9% at 12 mo. Clavien-Dindo grade ≥3 adverse events occurred in three patients (2.7%). CONCLUSIONS: In patients with localized RPPC, SWGC achieved excellent oncological outcomes with a low rate of urinary incontinence, and represents an alternative to salvage radical prostatectomy. Patients with fewer positive cores and lower PSA tended to have better oncological outcomes following SWGC. PATIENT SUMMARY: For men with prostate cancer that persists after radiotherapy, a freezing treatment applied to the whole prostate gland can achieve excellent cancer control. Patients who did not have elevated prostate-specific antigen (PSA) at 6 years after this treatment appeared to be cured.
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Criocirugía , Neoplasias de la Próstata , Masculino , Humanos , Criocirugía/métodos , Antígeno Prostático Específico , Próstata/cirugía , Resultado del Tratamiento , Estudios Retrospectivos , Recurrencia Local de Neoplasia/cirugía , Neoplasias de la Próstata/radioterapia , Neoplasias de la Próstata/cirugíaRESUMEN
PURPOSE: PI-RADS 4 lesions are considered to have a "high" likelihood of clinically-significant prostate cancer (csPCa). However, patients undergoing targeted biopsy have a range of histologic findings. Understanding discordant cases is critical to improve diagnostic accuracy and inform subsequent management. We studied early findings from implementation of a multidisciplinary Quality Improvement (QI) protocol for reconciling discordance and evaluate the potential heterogeneity of PI-RADS 4. METHODS: Patients with mpMRI PI-RADS 4 lesions undergoing fusion-targeted biopsy from January 2017 to May 2021 were retrospectively reviewed. The discordant targeted biopsy pathology (benign/GG1) was evaluated utilizing a QI protocol and all lesions were subcategorized based on ADC values. Positive Predictive Value (PPV) for PI-RADS 4 lesions overall and the Cancer Detection Rate (CDR) for subcategorized lesions were calculated. RESULTS: 248 patients with 286 lesions were reviewed. Prior to re-review, PI-RADS 4 PPV for ≥ GG1 and ≥ GG2 lesions were 0.55 and 0.34, increasing to 0.67 and 0.43 following reconciliation. Lesion subcategorization based on ADC value as higher suspicion (4+) and lower suspicion (4-) resulted in 158 and 117 lesions, with reverse-fusion analysis revealing that 61% and 17% of lesions contained csPCa, respectively. Subgroup analysis among PI-RADS 4+ lesions led to an increase in the CDR to 75% and 61% for ≥ GG1 and ≥ GG2. CONCLUSION: Use of multidisciplinary QI protocol to review discordance cases of PI-RADS 4 improves diagnostic accuracy and guides subsequent management. Our findings highlight the known heterogeneity of this category with reference to csPCa CDR, suggesting the potential value of PI-RADS 4 subcategorization.
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Neoplasias de la Próstata , Masculino , Humanos , Neoplasias de la Próstata/patología , Imagen por Resonancia Magnética/métodos , Estudios Retrospectivos , Mejoramiento de la Calidad , Biopsia Guiada por Imagen/métodosRESUMEN
BACKGROUND: Prostate cancer (PCa) diagnosis relies on biopsies, with transrectal ultrasound (TRUS) biopsies being common. Fusion biopsy (FB) offers improved diagnostic accuracy, but the pain and anxiety experienced by patients during biopsies is often overlooked. This study aims to compare pain and anxiety levels between standard TRUS-guided biopsy (STB) and systematic plus MRI/US fusion biopsy (STB + FB). MATERIALS AND METHODS: The study involved adult men undergoing biopsies, receiving identical peri-procedural care, including 2% lidocaine jelly in the rectum and subsequent 1% lidocaine injections (10cc per side) into the prostate-seminal vesicle junction and prostatic apical areas bilaterally. The biopsy technique was chosen based on clinical and imaging findings. Pre- and post-biopsy anxiety levels were assessed using the State-Trait Anxiety Inventory (STAI) questionnaire, categorized as mild (20-37), moderate (38-44), or severe (45-80). Post-biopsy pain was evaluated on a numerical rating scale, ranging from 0 to 10. RESULTS: Of the 165 patients, 99 underwent STB, and 66 underwent STB + FB. No significant differences were observed in age, race, prostate-specific antigen, prostate volume, or prior biopsies between the groups. The STB + FB group had more biopsy cores taken (16.2 vs. 12, p = 0.001) and a longer procedure time (23 vs. 10 min, p = 0.001). STB biopsy patients experienced lower post-procedural anxiety compared to STB + FB, with a mean difference of -7 (p = 0.001, d = 0.92). In the STB + FB group, 89% experienced severe post-procedural anxiety compared to 59% in STB (p = 0.002). There was no significant difference in post-procedural pain (p = 0.7). Patients with prior biopsies had significantly higher STAI(S) anxiety scores (p = 0.005), and the number of prior biopsies correlated with anxiety severity (p = 0.04) in STB + FB group. CONCLUSION: In summary, STB + FB group demonstrated higher post-procedural anxiety levels than the STB group, with no difference in pain levels. Additionally, patients with a history of repeat biopsies were more likely to exhibit higher STAI(S) anxiety scores.
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PURPOSE: Prostate cancer (PCa) screening can lead to potential over-diagnosis/over-treatment of indolent cancers. There is a need to optimize practices to better risk-stratify patients. We examined initial longitudinal outcomes of mid-life men with an elevated baseline prostate-specific antigen (PSA) following initiation of a novel screening program within a system-wide network. MATERIALS AND METHODS: We assessed our primary care network patients ages 40 to 49 years with a PSA measured following implementation of an electronic health record screening algorithm from 2/2/2017-2/21/2018. The multidisciplinary algorithm was developed taking factors including age, race, family history, and PSA into consideration to provide a personalized approach to urology referral to be used with shared decision-making. Outcomes of men with PSA ≥1.5 ng/mL were evaluated through 7/2021. Statistical analyses identified factors associated with PCa detection. Clinically significant PCa (csPCa) was defined as Gleason Grade Group (GGG) ≥2 or GGG1 with PSA ≥10 ng/mL. RESULTS: The study cohort contained 564 patients, with 330 (58.5%) referred to urology for elevated PSA. Forty-nine (8.7%) underwent biopsy; of these, 20 (40.8%) returned with PCa. Eleven (2.0% of total cohort and 55% of PCa diagnoses) had csPCa. Early referral timing (odds ratio [OR], 4.58) and higher PSA (OR, 1.07) were significantly associated with PCa at biopsy on multivariable analysis (both p<0.05), while other risk factors were not. Referred patients had higher mean PSAs (2.97 vs. 1.98, p=0.001). CONCLUSIONS: Preliminary outcomes following implementation of a multidisciplinary screening algorithm identified PCa in a small, important percentage of men in their forties. These results provide insight into baseline PSA measurement to provide early risk stratification and detection of csPCa in patients with otherwise extended life expectancy. Further follow-up is needed to possibly determine the prognostic significance of such mid-life screening and optimize primary care physician-urologist coordination.
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CONTEXT: Whole-gland ablation is a feasible and effective minimally invasive treatment for localized prostate cancer (PCa). Previous systematic reviews supported evidence for favorable functional outcomes, but oncological outcomes were inconclusive owing to limited follow-up. OBJECTIVE: To evaluate the real-world data on the mid- to long-term oncological and functional outcomes of whole-gland cryoablation and high-intensity focused ultrasound (HIFU) in patients with clinically localized PCa, and to provide expert recommendations and commentary on these findings. EVIDENCE ACQUISITION: We performed a systematic review of PubMed, Embase, and Cochrane Library publications through February 2022 according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. As endpoints, baseline clinical characteristics, and oncological and functional outcomes were assessed. To estimate the pooled prevalence of oncological, functional, and toxicity outcomes, and to quantify and explain the heterogeneity, random-effect meta-analyses and meta-regression analyses were performed. EVIDENCE SYNTHESIS: Twenty-nine studies were identified, including 14 on cryoablation and 15 on HIFU with a median follow-up of 72 mo. Most of the studies were retrospective (n = 23), with IDEAL (idea, development, exploration, assessment, and long-term study) stage 2b (n = 20) being most common. Biochemical recurrence-free survival, cancer-specific survival, overall survival, recurrence-free survival, and metastasis-free survival rates at 10 yr were 58%, 96%, 63%, 71-79%, and 84%, respectively. Erectile function was preserved in 37% of cases, and overall pad-free continence was achieved in 96% of cases, with a 1-yr rate of 97.4-98.8%. The rates of stricture, urinary retention, urinary tract infection, rectourethral fistula, and sepsis were observed to be 11%, 9.5%, 8%, 0.7%, and 0.8%, respectively. CONCLUSIONS: The mid- to long-term real-world data, and the safety profiles of cryoablation and HIFU are sound to support and be offered as primary treatment for appropriate patients with localized PCa. When compared with other existing treatment modalities for PCa, these ablative therapies provide nearly equivalent intermediate- to long-term oncological and toxicity outcomes, as well as excellent pad-free continence rates in the primary setting. This real-world clinical evidence provides long-term oncological and functional outcomes that enhance shared decision-making when balancing risks and expected outcomes that reflect patient preferences and values. PATIENT SUMMARY: Cryoablation and high-intensity focused ultrasound are minimally invasive treatments available to selectively treat localized prostate cancer, considering their nearly comparable intermediate- to long term cancer control and preservation of urinary continence to other radical treatments in the primary setting. However, a well-informed decision should be made based on one's values and preferences.
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Criocirugía , Neoplasias de la Próstata , Masculino , Humanos , Antígeno Prostático Específico , Estudios Retrospectivos , Neoplasias de la Próstata/cirugía , Resultado del Tratamiento , Criocirugía/efectos adversosRESUMEN
We report the rare case of a primary malignant melanoma of the urethra. An 89-year-old African American woman who was referred to our urology clinic for intermittent gross hematuria and a palpable vaginal mass of two months duration. Cystoscopy revealed a 3 cm mass in the distal urethra and urethral meatus that was surgically resected by wide local excision. The histopathologic diagnosis was primary malignant melanoma of the urethra. The patient was subsequently treated with adjuvant EBRT and immunotherapy with nivolumab and ipilimumab. Post-treatment PET-CT showed good response to treatment and patient remained in remission at eight month follow up.
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Despite newer therapies for castrate-resistant prostate cancer (CRPC), many patients do not experience a treatment response, and most eventually experience secondary resistance. Various androgen-receptor-related and alternative mechanisms of resistance in CRPC have been identified. This focus on understanding the molecular basis of therapeutic resistance, including lineage plasticity, neuroendocrine transformation, and a range of other implicated genomic alterations will hopefully inform decision-making in the care of this lethal cancer.
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Neoplasias de la Próstata Resistentes a la Castración , Masculino , Humanos , Neoplasias de la Próstata Resistentes a la Castración/tratamiento farmacológico , Neoplasias de la Próstata Resistentes a la Castración/genética , Resistencia a Antineoplásicos/genéticaRESUMEN
INTRODUCTION AND OBJECTIVES: Cryoablation offers a treatment option for small renal masses ideally suited ≤3 cm. In well-selected candidates, it is associated with less perioperative morbidity compared to more invasive options, such as partial or radical nephrectomy. However, little is known regarding device-related complications associated with the procedure. We provide an analysis of reports on renal cryoablation from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: Reports on renal cryoablation submitted to the MAUDE database from 2015 through 6/2021 were analyzed. Cases not pertaining to renal cryoablation were excluded (nâ¯=â¯33). Reports were examined to identify patient morbidity related to a potential device malfunction, as well as manufacturer assessment. Complications were graded based on an established MAUDE complication-reporting stratification. Fisher's Exact test was utilized to analyze for associations between device-related adverse events and severity of post-treatment sequelae. RESULTS: Two hundred and thirty-nine unique cases were identified. Adverse events were related to issues with the needles or system (212 cases), technical error (12 cases), or complication related to patient or tumor complexity (14 cases). There were 187 (78.6%) minor complications (MAUDE 1-2) and 52 (21.4%) major complications (MAUDE 3-4). The manufacturer performed formal device review in 164 (68.6%) cases, accepting responsibility for malfunction in 41. Notable MAUDE 3 complications included 29 (12.1%) cases aborted due to instrument/system malfunction and 14 (5.9%) cases of hemorrhage requiring a subsequent procedure. All 3 reported patient deaths (MAUDE 4) appeared to be a consequence of poor baseline health. On statistical analysis, major complications were seen in a significantly higher proportion of non-device related adverse events compared to device related events (85.2% vs. 13.7%, P < .001). CONCLUSION: While renal cryoablation is associated with low overall perioperative morbidity, there is a diverse set of device-related and procedural complications reported in recent years. Device-related adverse events were often associated with minor complications, and major complications were often seen in higher risk patients with comorbidities, more complex tumors, and after technical error. These findings highlight the need for standardized reporting of complications, optimized patient selection and counseling to ensure the best outcomes.
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Criocirugía , Criocirugía/efectos adversos , Bases de Datos Factuales , Humanos , Estados Unidos , United States Food and Drug AdministrationRESUMEN
There is uncertainty with how to proceed when targeted prostate biopsy of suspicious multiparametric magnetic resonance imaging (mpMRI) lesions return without clinically significant prostate cancer (csPCa). While possible, there are error sources that could contribute to such discordance including the mpMRI read, mpMRI-ultrasound fusion, biopsy technique, and histologic classification. Consequences are potentially significant; mistakenly missing csPCa can lead to delays in curative treatment. Conversely, in cases of incorrect mpMRI interpretation, the patient may be subjected to unnecessary workup/burden. At our institution, we implemented a quality improvement (QI) initiative triggered after a discordant case occurs. This multidisciplinary review process incorporates mpMRI re-review and assessment of accurate lesion-sampling, termed "reverse-fusion." Herein, we describe the protocol, present sample cases, and discuss clinical implications.