ABSTRACT
INTRODUCTION: [68 Ga]Ga-FAPI-46 PET/CT is a novel hybrid imaging method that previously showed additional diagnostic value in the assessment of distant urothelial carcinoma lesions. We hypothesized that patients with bladder cancer benefit from [68 Ga]Ga-FAPI-46 PET/CT prior to radical cystectomy for locoregional lymph node staging. MATERIALS AND METHODS: Eighteen patients underwent [68 Ga]Ga-FAPI-46 PET/CT for evaluation of lymph node (LN) status in predefined LN regions. Two hundred twenty-nine intraoperatively removed LN served as histopathological reference standard. RESULTS: Urothelial carcinoma (UC) spread was found in ten LN in seven different regions (14.3%). Hereby, [68 Ga]Ga-FAPI-46 PET/CT was positive in four out of seven regions (57.1%) and showed significantly increased FAPI uptake compared to non-pathological regions. In the remaining three out of seven (42.9%) regions, [68 Ga]Ga-FAPI-46 PET/CT was rated negative since no pathological increased FAPI uptake was detected or the proximity of the urinary tract prevented a differentiation from physiological uptake. CT was inconspicuous in these three regions. In total, two FAP-positive LN regions were found without histopathological counterpart. Overall, sensitivity, specificity, positive predictive value, and negative predictive value were 57.1%, 95.2%, 66.7%, and 93.0% for PET imaging. CONCLUSION: In summary, this innovative [68 Ga]Ga-FAPI-46 PET/CT method showed high specificity and negative predictive value in patients with bladder UC with a future potential to optimize therapy planning.
Subject(s)
Cystectomy , Neoplasm Staging , Positron Emission Tomography Computed Tomography , Quinolines , Urinary Bladder Neoplasms , Humans , Male , Urinary Bladder Neoplasms/diagnostic imaging , Urinary Bladder Neoplasms/pathology , Urinary Bladder Neoplasms/surgery , Female , Aged , Pilot Projects , Middle Aged , Lymphatic Metastasis/diagnostic imaging , Aged, 80 and over , Lymph Nodes/diagnostic imaging , Lymph Nodes/pathology , Gallium IsotopesABSTRACT
BACKGROUND: Salvage radical prostatectomy (sRP) is an important treatment option for patients with recurrent prostate cancer (PCa) after radiotherapy (RT) or focal therapy (FT). However, health-related quality of life (HRQOL) after sRP depending on the primary treatment is understudied. METHODS: Patients who underwent Salvage RP for recurrent PCa were analyzed. The primary outcome of this study was HRQOL assessed by the quality-of-life questionnaire (QLQ)-C30 and its prostate specific QLQ-PR25 add-on. Secondary outcomes were functional outcome parameters (erectile function, continence) and biochemical recurrence-free survival (BRFS). Statistical analyses employed the chi-square test, Mann-Whitney U test, and Kaplan-Meier method, with a p value < 0.05 denoting significance. RESULTS: 37 patients with RT as primary treatment (RT-sRP) and 22 patients with focal therapy prior sRP (FT-sRP) were analyzed. Mean global health score was not significantly different preoperatively (71.9 vs. 67.3, p = 0.89) as well as after a median of 32 months follow-up (54.9 vs. 50.6, p = 0.63) with impaired HRQOL after sRP in both groups. Baseline erectile dysfunction was more prevalent in the RT-sRP group (mean IIEF-5: 5.0) than in the FT-sRP group (mean IIEF-5: 8.5, p = 0.037). No differences were observed at follow-up for erectile function (IIEF-5-Score: 0.5 vs 2.5, p = 0.199) and continence (continence rate: 48.4% vs 52.9% (p = 0.763) between the RT-sRP and FT-sRP group. 5-year-BRFS was 60% (RT-sRP) and 68% (FT-sRP, p = 0.849). CONCLUSIONS: sRP impacts HRQOL in patients with PCa after RT and FT with no significant differences. Comparison with HRQOL and BRFS of treatment alternatives is paramount to counsel patients for appropriate treatments.
Subject(s)
Erectile Dysfunction , Prostatic Neoplasms , Male , Humans , Prostate , Quality of Life , ProstatectomyABSTRACT
OBJECTIVES: While the impact of treatment with 5-alpha Reductase Inhibitors (5-ARI) on the risk of cancer-related mortality in men with prostate cancer (PC) has been extensively studied, little is known about the impact of preoperative 5-ARI use on patient-reported outcomes (PROs) following radical prostatectomy (RP). METHODS: Within our prospectively maintained institutional database of 5899 patients treated with RP for PC (2008- 2021), 99 patients with preoperative 5-ARI therapy were identified. A 1:4 propensity-score matched analysis of 442 men (n = 90 5-ARI, n = 352 no 5-ARI) was conducted. Primary endpoint was continence recovery using daily pad usage and ICIQ-SF. Health-related quality of life (HRQOL) was assessed using the validated EORTC QLQ-C30 and PR25 questionnaires. Multivariable Cox-regression-models tested the effect of preoperative 5-ARI treatment on continence-recovery (p < 0.05). RESULTS: Patients were followed up perioperatively, followed by annual assessments up to 60mo postoperatively. Preoperative mean ICIQ-SF score (2.2 vs. 0.9) was significantly higher in the 5-ARI cohort (p = 0.006). 24mo postoperatively, 68.6% (no 5-ARI) vs. 55.7% (5-ARI) had full continence recovery (p = 0.002). Multivariable Cox regression analysis, revealed preoperative 5-ARI treatment as an independent predictor for impaired continence recovery (HR 0.50, 95% CI 0.27-0.94, p = 0.03) In line, general HRQOL was significantly higher for patients without 5-ARI only up to 24mo postoperatively (70.6 vs. 61.2, p = 0.045). There was no significant impact of preoperative 5-ARI treatment on erectile function, biochemical recurrence-free survival and metastasis-free survival. CONCLUSIONS: Pre-RP 5-ARI treatment was associated with impaired continence outcomes starting 24mo postoperatively, suggesting that preoperative 5-ARI treatment can impair the long-term urinary function recovery following RP.
Subject(s)
5-alpha Reductase Inhibitors , Propensity Score , Prostatectomy , Prostatic Neoplasms , Quality of Life , Humans , Male , Prostatectomy/methods , Prostatic Neoplasms/surgery , Aged , Middle Aged , 5-alpha Reductase Inhibitors/therapeutic use , Longitudinal Studies , Treatment Outcome , Patient Reported Outcome Measures , Preoperative Care/methods , Recovery of Function , Urinary IncontinenceABSTRACT
BACKGROUND: The impact of previous inguinal mesh hernioplasty (MH) with non-resorbable mesh prostheses on surgical performance of radical prostatectomy (RP) has been controversially discussed, with unknown impact of MH on oncologic outcomes and health-related quality of life (HRQOL) following RP. We therefore aimed to assess the influence of previous MH on metastasis-free survival (MFS), biochemical recurrence-free survival (BRFS), and HRQOL following RP. METHODS: We identified 344 patients with previous MH prior RP within our prospectively assessed institutional database of 6275 patients treated with RP for PC (2008-2019). A 1:3 propensity-score matched analysis of 1345 men (n = 319 previous MH, n = 1026 no previous MH) was conducted. Primary endpoint was MFS and secondary endpoints were BRFS and HRQOL (based on EORTC QLQ-C30). Binary logistic regression, Kaplan-Meier, and Cox regression models tested the effect of previous MH on MFS, BRFS, and HRQOL (p < 0.05). RESULTS: Median follow-up was 47 months. Patients with previous MH had significantly lower 5-year MFS (72% vs. 85%, p < 0.001) and 5-year BRFS estimates (43% vs. 57%, p < 0.001). In multivariate analysis, previous MH was confirmed as an independent predictor for impaired MFS (hazard ratio [HR]: 3.772, 95% CI 1.12-12.64, p = 0.031) and BRFS (HR: 1.862, 95% CI: 1.22-2.85, p = 0.004). These results held true if stratified for surgical approach or limited to patients with successful PLND. We found significantly shorter median time to continence recovery for patients without previous MH (p = 0.001) without significant differences in total continence recovery rates, erectile function recovery, and HRQOL. CONCLUSIONS: Our findings show an impaired oncologic outcome for patients with previous MH following RP with no significant differences regarding continence recovery, erectile function recovery, and general HRQOL.
Subject(s)
Erectile Dysfunction , Male , Humans , Erectile Dysfunction/etiology , Quality of Life , Herniorrhaphy , Surgical Mesh , Prostatectomy/methods , Patient Reported Outcome Measures , Prostheses and Implants , Retrospective StudiesABSTRACT
PURPOSE: Bilateral extended pelvic lymph node dissection at the time of radical prostatectomy is the current standard of care if pelvic lymph node dissection is indicated; often, however, pelvic lymph node dissection is performed in pN0 disease. With the more accurate staging achieved with magnetic resonance imaging-targeted biopsies for prostate cancer diagnosis, the indication for bilateral extended pelvic lymph node dissection may be revised. We aimed to assess the feasibility of unilateral extended pelvic lymph node dissection in the era of modern prostate cancer imaging. MATERIALS AND METHODS: We analyzed a multi-institutional data set of men with cN0 disease diagnosed by magnetic resonance imaging-targeted biopsy who underwent prostatectomy and bilateral extended pelvic lymph node dissection. The outcome of the study was lymph node invasion contralateral to the prostatic lobe with worse disease features, ie, dominant lobe. Logistic regression to predict lymph node invasion contralateral to the dominant lobe was generated and internally validated. RESULTS: Overall, data from 2,253 patients were considered. Lymph node invasion was documented in 302 (13%) patients; 83 (4%) patients had lymph node invasion contralateral to the dominant prostatic lobe. A model including prostate-specific antigen, maximum diameter of the index lesion, seminal vesicle invasion on magnetic resonance imaging, International Society of Urological Pathology grade in the nondominant side, and percentage of positive cores in the nondominant side achieved an area under the curve of 84% after internal validation. With a cutoff of contralateral lymph node invasion of 1%, 602 (27%) contralateral pelvic lymph node dissections would be omitted with only 1 (1.2%) lymph node invasion missed. CONCLUSIONS: Pelvic lymph node dissection could be omitted contralateral to the prostate lobe with worse disease features in selected patients. We propose a model that can help avoid contralateral pelvic lymph node dissection in almost one-third of cases.
Subject(s)
Prostatic Neoplasms , Male , Humans , Prostatic Neoplasms/diagnostic imaging , Prostatic Neoplasms/surgery , Prostatic Neoplasms/pathology , Lymph Node Excision/methods , Lymph Nodes/pathology , Biopsy , Prostatectomy/methods , Magnetic Resonance ImagingABSTRACT
PURPOSE: Several studies have shown baseline health-related quality of life to be a valuable prognostic indicator of survival outcomes for various cancer entities in the metastatic setting. To date, there is no evidence regarding the prognostic value of baseline health-related quality of life for patients undergoing radical prostatectomy due to localized prostate cancer. MATERIALS AND METHODS: A total of 1,029 patients with high-risk prostate cancer according to National Comprehensive Cancer Network® risk stratification and prospectively assessed baseline health-related quality of life prior to radical prostatectomy were identified. Patients were stratified by global health status domain of the QLQ-C30 questionnaire. Oncologic endpoints were biochemical recurrence-free survival and metastasis-free survival. Multivariable Cox regression models were performed to assess prognostic significance of baseline global health status on survival outcomes. Harrell's discrimination C-index was applied to calculate the predictive accuracy of the model and previously described risk stratification models. Decision curve analysis was applied to test the clinical net benefit associated with adding global health status to our multivariable model (P < .05). RESULTS: Median follow-up was 43 months. In multivariable analysis, global health status was confirmed as an independent predictor for increased biochemical recurrence-free survival (HR .97, 95% CI .96-.99; P = .001) and metastasis-free survival (HR .96, 95% CI .93-.99; P = .013), indicating a relative risk reduction of 2.9% for biochemical recurrence-free survival and 3.7% for metastasis-free survival per 1-point increase of baseline global health status. Adding baseline health-related quality of life to our model and to the Cancer of the Prostate Risk Assessment and National Comprehensive Cancer Network score improved discrimination in predicting biochemical recurrence-free survival and metastasis-free survival of the respective models. Decision curve analysis revealed a net benefit over all threshold probabilities. CONCLUSIONS: Our findings highlight baseline health-related quality of life to be a valuable and robust prognostic factor for patients with localized high-risk prostate cancer prior to radical prostatectomy. Baseline health-related quality of life increased prognostic accuracy of biochemical recurrence-free survival and metastasis-free survival.
Subject(s)
Prostate-Specific Antigen , Prostatic Neoplasms , Humans , Male , Neoplasm Recurrence, Local/epidemiology , Neoplasm Recurrence, Local/surgery , Prostatectomy , Prostatic Neoplasms/pathology , Quality of Life , Retrospective StudiesABSTRACT
PURPOSE: Our aim was to evaluate whether transperineal (TP) MRI-targeted prostate biopsy (TBx) may improve the detection of clinically significant prostate cancer (csPCa), defined as International Society of Urological Pathology ≥2, in comparison to transrectal (TR) TBx. MATERIALS AND METHODS: A multicenter retrospective cohort study comprising patients who underwent MRI-guided prostate biopsy was conducted. To address possible benefits of TP-TBx in the detection of prostate cancer (PCa) and csPCa, a cohort of patients undergoing TP-TBx were compared to patients undergoing TR-TBx. Multivariable logistic regression analyses were performed to assess predictors of PCa and csPCa detection. RESULTS: Overall, 1,936 and 3,305 patients who underwent TR-TBx vs TP-TBx at 10 referral centers were enrolled. The rate of PCa and csPCa diagnosed was higher for TP-TBx vs TR-TBx (64.0% vs 50%, p <0.01 and 49% vs 35%, p <0.01). At multivariable analysis adjusted for age, biopsy naïve/repeated biopsy, cT stage, Prostate Imaging-Reporting and Data System®, prostate volume, PSA, and number of biopsy cores targeted, TP-TBx was an independent predictor of PCa (odds ratio [OR] 1.37, 95% CI 1.08-1.72) and csPCa (1.19, 95% CI 1.12-1.50). When considering the approach according to the site of the index lesion, TP-TBx had a significantly higher likelihood than TR-TBx to detect csPCa in the apex (OR 4.81, 95% CI 1.03-6.27), transition/central zone (OR 2.67, 95% CI 1.42-5.00), and anterior zone (OR 5.62, 95% CI 1.74-8.13). CONCLUSIONS: The use of TP-TBx allows a better cancer grade definition and PCa risk assessment. This has important implication in the decision-making process and in patient counseling for further therapies.
Subject(s)
Prostatic Neoplasms , Urology , Humans , Image-Guided Biopsy , Magnetic Resonance Imaging , Male , Prostate/diagnostic imaging , Prostate/pathology , Prostatic Neoplasms/diagnostic imaging , Prostatic Neoplasms/pathology , Retrospective Studies , UrologistsABSTRACT
BACKGROUND: Incisional hernia is a frequent complication of abdominal wall incision. Surgical technique is an important risk factor for the development of incisional hernia. The aim of these updated guidelines was to provide recommendations to decrease the incidence of incisional hernia. METHODS: A systematic literature search of MEDLINE, Embase, and Cochrane CENTRAL was performed on 22 January 2022. The Scottish Intercollegiate Guidelines Network instrument was used to evaluate systematic reviews and meta-analyses, RCTs, and cohort studies. The GRADE approach (Grading of Recommendations, Assessment, Development and Evaluation) was used to appraise the certainty of the evidence. The guidelines group consisted of surgical specialists, a biomedical information specialist, certified guideline methodologist, and patient representative. RESULTS: Thirty-nine papers were included covering seven key questions, and weak recommendations were made for all of these. Laparoscopic surgery and non-midline incisions are suggested to be preferred when safe and feasible. In laparoscopic surgery, suturing the fascial defect of trocar sites of 10 mm and larger is advised, especially after single-incision laparoscopic surgery and at the umbilicus. For closure of an elective midline laparotomy, a continuous small-bites suturing technique with a slowly absorbable suture is suggested. Prophylactic mesh augmentation after elective midline laparotomy can be considered to reduce the risk of incisional hernia; a permanent synthetic mesh in either the onlay or retromuscular position is advised. CONCLUSION: These updated guidelines may help surgeons in selecting the optimal approach and location of abdominal wall incisions.
An incisional hernia results from a weakness of the abdominal wall muscles that allows fat from the inside or organs to bulge out. These hernias are quite common after abdominal surgery at the site of a previous incision. There is research that discusses different ways to close an incision and this may relate to the chance of hernia formation. The aim of this study was to review the latest research and to provide a guide for surgeons on how best to close incisions to decrease hernia rates. When possible, surgery through small incisions may decrease the risk of hernia formation. If small incisions are used, it may be better if they are placed away from areas that are already weak (such as the belly button). If the incision is larger than 1â cm, it should be closed with a deep muscle-fascia suture in addition to skin sutures. If there is a large incision in the middle of the abdomen, the muscle should be sutured using small stitches that are close together and a slowly absorbable suture should be used. For patients who are at higher risk of developing hernias, when closing the incision, the muscle layer can be strengthened by using a piece of (synthetic) mesh. There is no good research available on recovery after surgery and no clear guides on activity level or whether a binder will help prevent hernia formation.
Subject(s)
Abdominal Wound Closure Techniques , Incisional Hernia , Humans , Abdominal Wall/surgery , Abdominal Wound Closure Techniques/adverse effects , Incisional Hernia/epidemiology , Incisional Hernia/prevention & control , Incisional Hernia/surgery , Laparotomy , Suture Techniques , Practice Guidelines as TopicABSTRACT
PURPOSE: Nodal recurrent prostate cancer (PCa) represents a common state of disease, amenable to local therapy. PSMA-PET/CT detects PCa recurrence at low PSA levels. The aim of this study was to evaluate the outcome of PSMA-PET/CT-based salvage radiotherapy (sRT) for lymph node (LN) recurrence. METHODS: A total of 100 consecutive patients treated with PSMA-PET/CT-based salvage elective nodal radiotherapy (sENRT) for LN recurrence were retrospectively examined. Patients underwent PSMA-PET/CT scan due to biochemical persistence (bcP, 76%) or biochemical recurrence (bcR, 24%) after radical prostatectomy (RP). Biochemical recurrence-free survival (BRFS) defined as PSA < post-RT nadir + 0.2 ng/ml and distant metastasis-free survival (DMFS) were calculated using the Kaplan-Meier method and uni- and multivariate analysis was performed. RESULTS: Median follow-up was 37 months. Median PSA at PSMA-PET/CT was 1.7 ng/ml (range 0.1-40.1) in patients with bcP and 1.4 ng/ml (range 0.3-5.1) in patients with bcR. PSMA-PET/CT detected 1, 2, and 3 or more LN metastases in 35%, 23%, and 42%, respectively. Eighty-three percent had only pelvic, 2% had only paraaortic, and 15% had pelvic and paraaortic LN metastases. Cumulatively, a total dose converted to EQD21.5 Gy of 66 Gy (60-70 Gy) was delivered to the prostatic fossa, 70 Gy (66-72 Gy) to the local recurrence, if present, 65.1 Gy (56-66 Gy) to PET-positive lymph nodes, and 47.5 Gy (42.4-50.9 Gy) to the lymphatic pathways. Concomitant androgen deprivation therapy (ADT) was administered in 83% of patients. One-, 2-, and 3-year BRFS was 80.7%, 71.6%, and 65.8%, respectively. One-, 2-, and 3-year DMFS was 91.6%, 79.1%, and 66.4%, respectively. In multivariate analysis, concomitant ADT, longer ADT duration (≥ 12 vs. < 12 months) and LN localization (pelvic vs. paraaortic) were associated with improved BRFS and concomitant ADT and lower PSA value before sRT (< 1 vs. > 1 ng/ml) with improved DMFS, respectively. No such association was seen for the number of affected lymph nodes. CONCLUSIONS: Overall, the present analysis shows that the so far, unmatched sensitivity and specificity of PSMA-PET/CT translates in comparably high BRFS and DMFS after PSMA-PET/CT-based sENRT for patients with PCa LN recurrence. Concomitant ADT, duration of ADT, PSA value before sRT, and localization of LN metastases were significant factors for improved outcome.
Subject(s)
Positron Emission Tomography Computed Tomography , Prostatic Neoplasms , Androgen Antagonists , Gallium Radioisotopes , Humans , Lymphatic Metastasis , Male , Neoplasm Recurrence, Local/diagnostic imaging , Neoplasm Recurrence, Local/pathology , Prostate-Specific Antigen , Prostatectomy , Prostatic Neoplasms/diagnostic imaging , Prostatic Neoplasms/radiotherapy , Prostatic Neoplasms/surgery , Retrospective Studies , Salvage TherapyABSTRACT
BACKGROUND: [68Ga]Ga-FAPI-46 is a novel positron emission tomography (PET) ligand that targets fibroblast activation protein (FAP) expression as FAP inhibitor (FAPI) and could already show promising results in several tumor entities. It could be demonstrated that an increased FAP expression correlates with tumor aggressivity in urothelial carcinoma (UC). Given the limited value of [18F]FDG in UC, [68Ga]Ga-FAPI-46 could add diagnostic information in staging and response assessment in UC. We present the first data of [68Ga]Ga-FAPI-46 PET imaging in a pilot cohort of UC patients evaluating uptake characteristics in metastases and primary tumors. METHODS: Fifteen patients with UC prior to or after local treatment underwent [68Ga]Ga-FAPI-46 PET/CT imaging for detection of metastatic spread. We compared the biodistribution in non-affected organs and tumor uptake of UC lesions by standard uptake value measurements (SUVmean and SUVmax). Additionally, metastatic sites on PET were compared to its morphological correlate on contrast-enhanced computed tomography (CT). RESULTS: Overall, 64 tumor sites were detected on PET and/or CT. The highest uptake intensity was noted at the primary site (SUVmax 20.8 (range, 8.1-27.8)) followed by lymph node metastases (SUVmax 10.6 (range, 4.7-29.1)). In 4/15 (26.7%) patients there were [68Ga]Ga-FAPI-46-positive lesions that were missed on standard routine CT imaging. On the other hand, 2/15 patients had suspicious prominent bipulmonary nodules as well as pelvic lymph nodes previously rated as suspicious for metastatic spread on CT, but without increased FAPI expression; here histopathology excluded malignancy. CONCLUSION: [68Ga]Ga-FAPI-46 PET shows distinctly elevated uptake in UC lesions. Therefore, the tracer has potential as a promising new biomarker in metastatic UC patients, as [68Ga]Ga-FAPI-46 PET might improve detection of metastatic sites compared to CT alone. These findings highly emphasize larger studies investigating FAPI imaging in UC patients.
Subject(s)
Carcinoma, Transitional Cell , Urinary Bladder Neoplasms , Feasibility Studies , Fluorodeoxyglucose F18 , Gallium Radioisotopes , Humans , Positron Emission Tomography Computed Tomography/methods , Quinolines , Tissue DistributionABSTRACT
PURPOSE: To provide first evidence of lymph node (LN) staging using CT scan and its prognostic value in variant histologies of bladder cancer. This knowledge may optimize patient management with variant histologies based on CT morphological findings. METHODS: Preoperative CT scans of patients with variant histologies who underwent RC between 2004 and 2019 were reanalyzed by two independent radiologists in a blinded review process. Specificity, sensitivity, and accuracy for LN staging as well as LN characteristics were evaluated. Correlation with survival was investigated by Kaplan-Meier method, log-rank test and multivariate analysis. RESULTS: 1361 patients with primary tumor of the bladder underwent RC, of which 163 (12%) patients revealed variant histologies. 65 (47.8%) patients have shown an urothelial variant (UV) and 71 (52.2%) a non-urothelial variant (NUV). LN metastases were found in 18 (27.7%) patients with UV and 21 (29.6%) patients with NUV. The accuracy to detect LN metastasis for all variant histologies was 62% with a sensitivity of 46% and a specificity of 70%. Subgroups of UV and NUV revealed an accuracy of 67% and 57%. An increased number of regional LN (HR 2.8; 1.34-6.18) and the loss of fatty hilum (HR 0.36, 0.17-0.76) were prognostic parameters. In multivariate analysis, a fatty hilum (HR 0.313, 0.104-0.945) and the presence of lymph node metastases (HR 2.866, 1.140-7.207) were prognostic. CONCLUSION: This first study on CT morphological behavior of variant histologies revealed an accuracy of UV and NUV comparable to UC with low specificity for all variant histologies. CT scan prior RC should be interpreted in regard to histological subtypes.
Subject(s)
Urinary Bladder Neoplasms , Humans , Lymph Nodes/pathology , Lymphatic Metastasis/diagnostic imaging , Lymphatic Metastasis/pathology , Neoplasm Staging , Prognosis , Tomography, X-Ray Computed , Urinary Bladder Neoplasms/pathologyABSTRACT
PURPOSE: ExoDx Prostate IntelliScore (EPI) is a non-invasive urine exosome RNA-based test for risk assessment of high-grade prostate cancer. We evaluated the association of pre-biopsy test results with post-radical prostatectomy (RP) outcomes to understand the potential utility of EPI to inform invasive treatment vs active surveillance (AS) decisions. METHODS: Urine samples were collected from 2066 men scheduled for initial biopsy with PSA between 2 and 10 ng/mL, no history of prostate cancer, and ≥ 50 years across multiple clinical studies. 310 men proceeded to RP, of which 111 patients had Gleason group grade 1 (GG1) at biopsy and would have been potential candidates for AS. We compared pre-biopsy urine scores with ERSPC and PCPT multivariate risk calculator scores for men with GG1 at biopsy to post-RP pathology. RESULTS: Urine EPI scores were significantly lower in men with GG1 at biopsy than in men with > GG1 (p = 0.04), while there were no differences in multivariate risk scores used in standard clinical practice (p > 0.05). Further, EPI scores were significantly lower in men with GG1 at biopsy who remained GG1 post-RP compared to men upgraded to ≥ GG3 post-RP (p < 0.001). In contrast, none of the multiparametric risk calculators showed significant differences (p > 0.05). Men with GG1 at biopsy and EPI score < 15.6 had zero rate of upgrading to ≥ GG3 post-RP compared to 16.0% for EPI scores ≥ 15.6. CONCLUSIONS: The EPI urine biomarker outperformed the multivariate risk calculators in a homogenous risk group of pre-biopsy men. The EPI score was associated with low-risk pathology post-RP, with potential implications on informing AS decisions. TRIAL REGISTRATION: NCT02702856, NCT03031418, NCT03235687, NCT04720599.
Subject(s)
Prostatic Neoplasms , RNA , Biopsy/methods , Clinical Trials as Topic , Humans , Male , Multicenter Studies as Topic , Neoplasm Grading , Prostate/pathology , Prostate-Specific Antigen , Prostatectomy/methods , Prostatic Neoplasms/diagnosis , Prostatic Neoplasms/genetics , Prostatic Neoplasms/surgeryABSTRACT
PURPOSE OF REVIEW: To investigate the features and optimal management of pN+ cM0 prostate cancer (PCa) according to registry-based studies. RECENT FINDINGS: Up to 15% of PCa patients harbor lymph node invasion (pN+) at radical prostatectomy plus lymph node dissection. Nonetheless, the optimal management strategy in this setting is not well characterized. SUMMARY: We performed a systematic review including nâ=â13 studies. Management strategies comprised 13â536 men undergoing observation, 11â149 adjuvant androgen deprivation therapy (aADT), 7,075 adjuvant radiotherapy (aRT) +aADT and 705 aRT. Baseline features showed aggressive PCa in the majority of men. At a median follow-up ranging 48-134months, Cancer-related death was 5% and overall-mortality 16.6%. aADT and aRT alone had no cancer-specific survival or overall survival advantages over observation only and over not performing aRT, respectively. aADT plus aRT yielded a survival benefit compared to observation and aADT, which in one study, were limited to certain intermediate-risk categories. Age, Gleason, Charlson score, positive surgical margins, pathological stage, and positive nodes number, but not prostate specific antigen, were most relevant prognostic factors. Our work further confirmed pN+ PCa is a multifaceted disease and will help future research in defining its optimal management based on different risk categories to maximize survival and patient's quality of life.
Subject(s)
Androgen Antagonists , Prostatic Neoplasms , Humans , Lymph Node Excision , Lymphatic Metastasis , Male , Neoplasm Staging , Prostate-Specific Antigen , Prostatectomy , Prostatic Neoplasms/pathology , Prostatic Neoplasms/surgery , Quality of Life , Radiotherapy, Adjuvant , Retrospective StudiesABSTRACT
INTRODUCTION: Indication of ureteroscopy for the treatment of urolithiasis has expanded immensely over the last decade. Fiber-optic and digital reusable instruments present the standard in clinical practice, but various newly available single-use devices might offer an exciting alternative. To date, the evidence is limited to clinical evaluation and efficacy of single-use ureteroscopes (URS) compared to standard instruments. Therefore, we evaluate a single-use instrument's clinical characteristics and efficacy in direct comparison with a fiber-optic and digital device. METHODS: A prospective study was conducted for patients undergoing endoscopic therapy for urolithiasis at a tertiary care center. We evaluated the different instruments' clinical performance in categories of visibility, the stability of visibility, irrigation flow, and surgeon's satisfaction. Statistical analyses were performed by SPSS using the Chi-Quadrat and Kruskal-Wallis test. A p value of p ≤ 0.05 was defined as statistically significant. RESULTS: A total number of 77 patients were included and distributed as follows: 35 (46.7%) single-use, 19 (25.3%) digital, and 23 (28%) fiber-optic URS. Patients' characteristics were homogenous over the three cohorts in sex, stone amount, and localization. The stone-free rate was equal in all three cohorts (p = 0.31). We identify stability of visibility, irrigation flow, and satisfaction were equal in all cohorts (p = 0.73; p = 0.20; p = 0.20). We report a significant difference in visibility, with 100% rated excellent in the digital URS group (p = 0.028). DISCUSSION/CONCLUSIONS: Single-use URS achieve comparable clinical outcomes with equal stone-free rates in direct comparison with fiber-optic and digital reusable instruments. Accordingly, single-use devices present an adequate alternative for endoscopic therapy of urolithiasis.
Subject(s)
Kidney Calculi , Urolithiasis , Equipment Design , Female , Humans , Kidney Calculi/surgery , Male , Prospective Studies , Treatment Outcome , Ureteroscopes , Ureteroscopy , Urolithiasis/surgeryABSTRACT
INTRODUCTION: Palliative radical cystectomy (pRC) may be offered to selected bladder cancer (BC) patients with grievous local symptoms. However, there is only scarce information on perioperative complications and prognosis, especially in the case of metastatic spread. We intended to analyze morbidity and oncological outcome in this patient subgroup. MATERIALS: Patients undergoing pRC because of BC with radiologic evidence of metastases were included in this retrospective study. Perioperative adverse events (AEs) were graded by the Clavien-Dindo Classification system. All patients underwent CT-based surveillance, and questionnaires were sent for survival follow-up in predefined intervals. Oncological outcome and predictive markers were assessed in univariate and multivariate analyses, using log-rank tests and Cox-regression analyses. RESULTS: Between 2004 and 2016, 77 patients were identified. Median age at surgery was 70 years (IQR 66-77) and the median follow-up time was 12 months (IQR 4-44). Preoperative staging revealed pulmonary, hepatic, bone, peritoneal, and various other metastasis in 46/77 (60%), 14/77 (18%), 11/77 (14%), 5/77 (7%), and 11/77 (14%) cases, respectively. Most frequently observed symptoms at the time of pRC were severe gross hematuria (n = 41) and intense pain (n = 11). Most AEs were of minor grade (83%). The median length of stay was 20 days. Median CSS was 13 months with a 5-year CSS of 34%. Intriguingly and unsuspectedly, preoperatively suspicious lung lesions were confirmed during surveillance only in 33%, respectively. In multivariate analysis, intraoperative blood transfusions (HR = 2.25, 95% CI: 1.09-4.63, p = 0.028) were significantly associated with decreased CSS. The best outcome was observed in patients with only subpleural metastases (CSS 80 months, p = 0.039) and normal CRP- and Hb values. CONCLUSION: pRC can be performed with acceptable perioperative morbidity and mortality. Pulmonary lesions seem to have a risk of false-positive results and should be biopsied in all uncertain cases. Localization of lung metastases together with preoperative CRP- and Hb levels seem to play a prognostic role.
Subject(s)
Carcinoma, Transitional Cell , Urinary Bladder Neoplasms , Carcinoma, Transitional Cell/surgery , Cystectomy/methods , Humans , Prognosis , Retrospective Studies , Tomography, X-Ray Computed , Urinary Bladder Neoplasms/diagnostic imaging , Urinary Bladder Neoplasms/surgeryABSTRACT
BACKGROUND: Evidence regarding the impact of giant prostate volume (PV) on outcome after radical prostatectomy (RP) is controversial with a lack of evidence on the impact of PV on health-related quality of life (HRQOL). We aimed to assess the impact of giant PV on HRQOL and functional outcomes for men with prostate cancer (PC) undergoing RP. METHODS: Giant PV was defined based on the 95th percentile of PV measured by specimen weight of 3929 patients that underwent RP between 2013 and 2018 in a large tertiary care center. A propensity score-matched analysis of 929 men treated with RP for PC (n = 184 with PV ≥ 100 cm3 , n = 745 with PV < 100 cm3 ) was conducted. Primary endpoint was the impact of giant PV on HRQOL (based on EORTC QLQ-C30) assessed with binary logistic regression and Cox proportional hazard model. Secondary endpoint was the impact of PV on oncological- and functional outcome. RESULTS: Median follow-up was 24 months. Median PV, measured by specimen-weight, was 58 cm3 . We found no significant differences in median general HRQOL (p = .183), giant PV was not associated with better HRQOL (odds ratio [OR], 1.54; 95% confidence interval [CI], 0.96-2.47; p = .075). No significant differences were found regarding continence recovery (hazard ratio [HR], 0.956; 95% CI, 0.771-1.185; p = .682), median International Consultation of Incontinence Questionnaire-Short-Form (ICIQ-SF) scores (p = .062) or potency rates (p = .151). Giant PV did not significantly impair biochemical recurrence-free survival (HR, 0.968; 95% CI, 0.651-1.439; p = .871). CONCLUSIONS: For patients undergoing RP, giant PV was not associated with adverse HRQOL outcomes. We found no significant impact of PV on continence rates, potency rates, and biochemical recurrence-free survival. Hence, RP is an efficient cancer treatment for men even with giant PV.
Subject(s)
Prostate/surgery , Prostatectomy/psychology , Prostatic Neoplasms/surgery , Quality of Life/psychology , Aged , Humans , Male , Middle Aged , Prostatic Neoplasms/mortality , Prostatic Neoplasms/psychology , Surveys and Questionnaires , Survival Rate , Treatment OutcomeABSTRACT
PURPOSE: The optimal timing of radiotherapy (RT) after radical prostatectomy (RP) remains controversial with unknown impact on health-related quality of life (HRQOL). We aimed to compare the influence of early RT (eRT) and deferred RT (dRT) on HRQOL. MATERIALS AND METHODS: A total of 4,511 patients were analyzed. Inclusion criteria encompassed: ≥pT3, International Society of Urological Pathology grade ≥4, or positive surgical margin. A 1:4 propensity score-matched-analysis of 1,599 patients was conducted (307: eRT, ≤6 months after RP; 1,292: dRT, >6 months after RP). Primary end point was general HRQOL (based on European Organisation for Research and Treatment of Cancer QLQ-C30). Pearson correlation and binary logistic regression models were used to estimate the impact of timing of RT on HRQOL. Functional outcome was assessed using the International Consultation on Incontinence Questionnaire, short form (ICIQ-SF) and International Index of Erectile Function (IIEF-5) questionnaires. RESULTS: Median followup was 38 months. At 12 months and 24 months followup, general HRQOL scores were significantly higher for dRT (52.7 vs 35.5; p=0.001; 45.8 vs 37.3; p=0.026). ICIQ-SF scores were higher (8.5 vs 6.1; p=0.001; 8.4 vs 7.3; p=0.038), and IIEF-5 scores were lower (1.8 vs 4.2; p=0.001; 2.2 vs 4.4; p=0.005) for eRT at 12 months and 24 months. On multivariate-analysis, dRT was associated with superior general HRQOL at 12 months (OR 0.59, 95% CI 0.37-0.94, p=0.027) and 24 months (OR 0.64, 95% CI 0.39-0.99, p=0.043), respectively. A longer time interval between RP and RT was associated with improved general HRQOL (OR 1.09, 95% CI 1.038-1.143; p <0.001). CONCLUSIONS: dRT yields improved short-term HRQOL compared to eRT. Since longer time intervals between RP and RT predict better short-term HRQOL, our data provide further support for the concept of deferred RT at low prostate specific antigen recurrence.
Subject(s)
Prostatectomy/adverse effects , Prostatic Neoplasms/therapy , Quality of Life , Radiation Injuries/epidemiology , Time-to-Treatment/statistics & numerical data , Aged , Erectile Dysfunction/diagnosis , Erectile Dysfunction/epidemiology , Erectile Dysfunction/etiology , Erectile Dysfunction/psychology , Follow-Up Studies , Humans , Male , Middle Aged , Prostate/pathology , Prostate/radiation effects , Prostate/surgery , Radiation Injuries/diagnosis , Radiation Injuries/etiology , Radiation Injuries/psychology , Radiotherapy, Adjuvant/adverse effects , Radiotherapy, Adjuvant/statistics & numerical data , Retrospective Studies , Treatment Outcome , Urinary Incontinence/diagnosis , Urinary Incontinence/epidemiology , Urinary Incontinence/etiology , Urinary Incontinence/psychologyABSTRACT
INTRODUCTION: Urolithiasis is a common diagnosis in urology. New technologies offer a variety of diagnostic and therapy and consequently display a financial burden on healthcare systems. Hence, clinical practice guidelines (CPG) are essential to implement evidence-based medicine and assure a standard of care considering limited resources. To date, there is no evidence of the use and adherence to CPG on urolithiasis. MATERIAL AND METHODS: Therefore, we performed a cross-sectional study to analyze the use of CPG on urolithiasis. Data collection was carried out by a questionnaire given to 400 German urologists. The survey included use and adherence to guidelines, evaluation of the clinical situation, therapy spectrum, and workplace. In total, 150 (37%) questionnaires were received and included in our survey. Statistics were performed by SPSS using Chi-quadrat test/Fisher's exact test. RESULTS: In our study, urologists were office based, hospital affiliated, non-academic, or academic centers in 53%, 32%, 16% and 5%, respectively. In 74% and 70%, urologists adhere to CPG in diagnostic and therapy. Interestingly, workplace and therapy spectrum determines the use of different CPG (p = 0.01; p = 0.022). Academic urologists were more likely to use international CPG of EAU (40%), while outpatient urologists significantly orientated on national CPG (46%). 86% of urologists with high volume of urolithiasis practice interventions in contrast to 53% in low volume (p = 0.001). More than 80% of urologists use short versions and app version of CPG. CONCLUSION: We firstly describe compliance and the use of CPG on urolithiasis. EAU and DGU present the most commonly used CPG. Short version and app version of CPG find frequent clinical utilization.
Subject(s)
Attitude of Health Personnel , Critical Pathways/standards , Guideline Adherence , Practice Guidelines as Topic , Practice Patterns, Physicians'/standards , Urolithiasis/therapy , Cross-Sectional Studies , Germany/epidemiology , Health Services Research/methods , Humans , Surveys and Questionnaires , Urolithiasis/epidemiology , Urologists/statistics & numerical data , WorkplaceABSTRACT
PURPOSE: To investigate differences in standard preoperative inflammatory markers in patients with urothelial carcinoma (UC) and variant histologies undergoing radical cystectomy (RC) and determine its impact on survival. METHODS: Patients undergoing RC at an academic high-volume center were retrospectively analyzed. Preoperatively taken CRP, leukocytes, hemoglobin (Hb), and thrombocytes were analyzed as routine inflammatory biomarkers. Log-rank tests and Kruskal-Wallis analysis were used to calculate for differences in survival and in blood levels of biomarkers. RESULTS: 886 patients with complete follow-up and UC or variant histology underwent RC at our institution between 2004 and 2019. Although variant histology presents with significantly higher t stage than UC, cancer-specific survival (CSS) of UC (1-year-CSS: 93%) is not significantly different to variant histology of UC with squamous differentiation (UCSD, 1-year-CSS: 81%), squamous cell carcinoma (SCC, 1-year-CSS: 82%), and adenocarcinoma (AC, 1-year-CSS: 81%). In UC, alterations in all biomarkers except leukocytes beyond routine cut-off values were associated with poor survival (p < 0.01), whereas Hb beyond cut-off values are associated with poor prognosis in SCC (p < 0.05). CRP levels are significantly elevated in UCSD and SCC at time of surgery compared to UC (p < 0.05). CONCLUSION: Inflammatory biomarkers reveal distinctive patterns across UC and variant histologies of bladder cancer. As inflammation might play an important role in cancer progression, further research is warranted to understand those molecular mechanisms and their potential therapeutic impact in variant histology of bladder cancer.
Subject(s)
Adenocarcinoma/mortality , Adenocarcinoma/pathology , Carcinoma, Squamous Cell/mortality , Carcinoma, Squamous Cell/pathology , Carcinoma, Transitional Cell/mortality , Carcinoma, Transitional Cell/pathology , Cystectomy , Urinary Bladder Neoplasms/mortality , Urinary Bladder Neoplasms/pathology , Urinary Bladder Neoplasms/surgery , Adenocarcinoma/surgery , Aged , Biomarkers/blood , Carcinoma, Squamous Cell/surgery , Carcinoma, Transitional Cell/blood , Carcinoma, Transitional Cell/surgery , Cystectomy/methods , Female , Humans , Male , Middle Aged , Prognosis , Retrospective Studies , Survival Rate , Urinary Bladder Neoplasms/bloodABSTRACT
PURPOSE: To assess the impact of previous transurethral surgery for benign prostate enlargement (BPE) and time interval between procedures on functional outcomes and health-related quality of life (HRQOL) after radical prostatectomy (RP). METHODS: A propensity score-matched patient cohort [n = 685, (513 without previous BPE surgery, 172 with BPE surgery)] was created and HRQOL was pre- and postoperatively assessed using validated questionnaires (EORTC QLQ-C30). Urinary continence was measured via ICIQ-SF questionnaire and pad usage. Multivariable analysis included binary logistic and Cox regression models (p < 0.05). RESULTS: Median follow-up was 18 months. There was no significant difference in recurrence-free survival in multivariate analysis (HR 0.66, 95%CI 0.40-1.07, p = 0.093). We observe higher mean ICIQ-SF scores (5.7 vs. 8.2, p < 0.001) and daily pad usage (1.3 vs. 2.5, p < 0.001), and decreased continence recovery (OR 0.46, 95%CI 0.30-0.71, p < 0.001) for patients with BPE surgery. Postoperative general HRQOL scores were significantly lower for patients with previous BPE surgery (70.6 vs. 63.4, p = 0.003). In multivariate analysis, continence recovery (OR 5.19, 95%CI 3.10-8.68, p < 0.001) but not previous BPE surgery (0.94, 0.57-1.54, p = 0.806) could be identified as independent predictors of good general HRQOL. There was no significant correlation between time interval between both surgeries and continence (p = 0.408), and HRQOL (p = 0.386) outcomes. CONCLUSIONS: We observe favourable continence outcomes for patients without previous BPE surgery. Our results indicate that RP can be safely performed after transurethral BPE surgery, regardless of the time interval between both interventions.