Clinical Recurrence-free Survival Research Articles

Image-Guided Stereotactic Body Radiotherapy on Detectable Prostate Bed Recurrence after Prostatectomy in RT-Naïve Patients.

Eighty-six patients who underwent SBRT for macroscopic bed recurrence after prostatectomy were retrospectively included. Patients were treated based on mpMRI or choline/PSMA PET. The median time to biochemical relapse (BCR) after RP was 46 months, with a median PSA at restaging of 1.04 ng/mL. Forty-six patients were staged with mpMRI and choline/PSMA PET, while ten and thirty were treated based on PET and MRI only, respectively. Only one late G ≥ 2 GI toxicity was observed. With a median BCR follow-up of 14 months, twenty-nine patients experienced a BCR with a median PSA at recurrence of 1.66 ng/mL and a median survival free from the event of 40.1 months. The median time to BCR was 17.9 months. Twenty-seven patients had clinical relapse (CR), with a median CR follow-up of 16.27 months and a median time to CR of 23.0 months. Biochemical recurrence-free survival at one and two years was 88% and 66%, respectively, while clinical recurrence-free survival at one and two years was 92% and 82%, respectively. Regarding local relapses, seven were in the field of treatment, while eight of them were outside the field of treatment. Data showed that SBRT targeting only the macroscopic bed recurrence instead of the whole prostate bed is safe and effective. Additional data and longer follow-ups will provide a clearer indication of the appropriate treatment and staging methodology for these patients.

Location-Based Oncological Outcomes of Sentinel Node Dissection in Radical Prostatectomy.

Our study aimed to assess the oncological outcomes of sentinel node dissection during radical prostatectomy according to nodal location in comparison to extended pelvic lymph node dissection. Prospectively collected data of clinically node-negative patients who underwent prostatectomy and extended lymph node dissection with or without sentinel node from January 2013 to January 2023 were retrospectively analyzed. The primary end point was to assess oncological outcomes on the whole population. Kaplan-Meier curves were used to depict biochemical and clinical recurrence-free survival. Multivariable Cox regression models assessed the impact of nodal location on single-photon emission computed tomography on oncological outcomes. Adjustment for case mix included: pathological T stage, ISUP (International Society of Urological Pathology) grade group, initial PSA, nodal burden, age at surgery, and surgical margin status. Secondarily, a propensity score match was performed according to age at surgery, PSA, biopsy ISUP, clinical T stage, and Briganti risk of nodal invasion. Survival and regression analyses were also performed in the matched population. Of the patients, 55.8% had at least 1 sentinel node outside of lymph node dissection template at single-photon emission computed tomography/CT. Log-rank test showed comparable 36-month biochemical (P = .3) and clinical recurrence-free survival (P = .6) among patients with sentinel node inside template, outside template, or extended pelvic lymph node dissection alone. At Cox regression, sentinel node location outside template was associated with lower hazard of metastases (HR 0.62; P = .04) in the overall cohort, while in the matched cohort benefits were observed only for biochemical recurrence (HR 0.57; P = .001). Wider nodal resection boundaries outside the "classic" template, driven by sentinel node procedure, have a positive impact on oncological outcomes in selected patient.

SnRNAs from Radical Prostatectomy Specimens Have the Potential to Serve as Prognostic Factors for Clinical Recurrence after Biochemical Recurrence in Patients with High-Risk Prostate Cancer.

In patients with high-risk prostate cancer (HRPC) after radical prostatectomy (RP), biochemical recurrence (BCR) increases the risk of distant metastasis. Accordingly, additional prognostic biomarkers are required to identify the subpopulation of patients with HRPC who develop clinical recurrence (CR) after BCR. The objective of this study was to identify biomarkers in formalin-fixed paraffin-embedded (FFPE) RP samples that are prognostic for CR in patients with HRPC who experience BCR after RP (post-RP BCR). First, we performed a preliminary RNA sequencing analysis to comprehensively profile RNA expression in FFPE RP samples obtained from patients with HRPC who developed CR after post-RP BCR and found that many snRNAs were very abundant in preserved FFPE samples. Subsequently, we used quantitative polymerase chain reaction (qPCR) to compare the expression levels of highly abundant snRNAs in FFPE RP samples from patients with HRPC with and without CR after post-RP BCR (21 CR patients and 46 non-CR patients who had more than 5 years of follow-up after BCR). The qPCR analysis revealed that the expression levels of snRNA RNU1-1/1-2 and RNU4-1 were significantly higher in patients with CR than in patients without CR. These snRNAs were significantly correlated with clinical recurrence-free survival (RFS) in patients with HRPC who experienced post-RP BCR. Furthermore, snRNA RNU1-1/1-2 could serve as an independent prognostic factor for clinical RFS in post-RP BCR of HRPC cases where known prognostic factors (e.g., Gleason score) cannot distinguish between CR and non-CR patients. Our findings provide new insights into the involvement of snRNAs in prostate cancer progression.

P573 Simplified MARIA score does not predict long-term outcomes in Crohn’s disease patients undergoing modified side-to-side strictureplasty for extensive ileitis

Abstract Background Strictureplasty techniques were developed to limit the risk of short bowel syndrome in Crohn’s disease (CD) patients with affected small intestine. In the setting of extensive small bowel disease, long strictures might be treated with modified side-to-side isoperistaltic strictureplasty (SSIS). We studied long-term outcomes in patients who underwent SSIS and evaluated if radiological features on MR enterography (MRE) predict them. Methods This retrospective study included CD patients who underwent SSIS, for whom preoperative and six-month postoperative MRE were routinely performed. Simplified MARIA (MARIAs) score, considering wall thickness, edema, fat stranding and ulcers (score >1 active CD; maximum 5) was used. Improvement in maximal wall thickness was defined as decrease of at least 30% from baseline. Deep remission was defined as absence of symptoms and endoscopic remission (mRutgeerts score ≤i1), and clinical recurrence as occurrence of new symptoms confirmed by endoscopy (mRutgeerts score ≥i2b) or radiology (new strictures/inflammation) requiring treatment. Clinical data were collected from medical records. The correlation between recurrence and features within the MARIAs score was assessed. Results Thirty CD patients underwent SSIS and had pre- and six-month postoperative MRE (table). Immediately after surgery, 13 (43.3%) patients were continued or initiated on advanced therapy. Over a median [IQR] follow-up of 7.4 [3.3-9.3] years, 17 (56.7%) patients showed clinical recurrence of whom 6 (20.0%) needed surgical reintervention (figure). Deep remission was observed in 8 (26.7%) patients. Preoperatively, all patients had a maximum MARIAs score of 5. After surgery, the median [IQR] change in MARIAs score was 0.0 [0.0-0.8]. Cox regression analysis showed no association between decrease in overall MARIAs score, nor separate components of this score, with clinical or surgical recurrence free survival. Wall thickness decrease of >30%, observed in 15 (50%) patients, showed a trend for clinical recurrence free survival (p=0.098). Three patients showed normalization of MARIAs score and showed no recurrence thereafter. None of the clinical variables collected showed significant association with recurrence, except for immediate postoperative advanced therapy which had a 70% protection from clinical recurrence [p=0.036 / HR 0.3 (0.097-0.92)]. Conclusion Long-term follow-up of CD patients undergoing SSIS showed that 57% of patients had clinical recurrence and 20% needed surgical reintervention. The MARIAs score was not predictive of long-term postoperative clinical or surgical recurrence as most features of the score remained unaltered. These shortcomings of the MARIAs score should be addressed when designing improved scoring tools.

P387 Short and long-term outcomes of surgery for inflammatory (uncomplicated) ileocecal Crohn’s disease: multicentric retrospective analysis of 211 patients

Abstract Background Surgical management for patients with inflammatory ileocecal Crohn’s disease (CD) could be a reasonable alternative to second-line medical treatment. Methods A retrospective analysis of patients intervened for primary ileocecal CD with uncomplicated (inflammatory) phenotype at four referral hospitals during 2012-2021 was performed. The objective was to assess short and long-term outcomes of patients operated on for inflammatory, ileocecal CD. Patients operated on due to inflammatory ileocecal CD (last 50 cm of the terminal ileum and cecum), were considered eligible to participate in this study. Operations performed during a 9-year period (2012-2021) were considered for the study. Patients who were operated for CD for advanced structural bowel damage (fibrotic strictures or penetrating phenotype), those who had had previous abdominal CD-related procedures, and patients who had disease activity in other anatomical regions at the time of surgery, were excluded from the study. Results 211 patients were included. 43% of patients underwent surgery more than 5 years after diagnosis, and 49% had been exposed to at least one biologic agent preoperatively. 89% were operated by laparoscopy, with 1.6% conversion rate. The mean length of stay for patients was 5 days, with only 24 patients (11%) requiring a prolonged hospitalization. The complication rate was 23.7% (50 patients), but most complications were minor (Clavien-Dindo < IIIa), with only 11 patients (5%) presenting with major complications. Leak rate for patients who received a primary anastomosis was 2.9%. The median length of the resected bowel was 25 cm (7-92) and three patients (1.43%) received a stoma. Median follow-up was 36 (17-70) months. The endoscopic recurrence-free survival proportion at 24, 48, 72, 96, and 120 months was 56%, 52%, 45%, 38%, and 33%, respectively. The clinical recurrence-free survival proportion at 24, 48, 72, 96, and 120 months was 83%, 79%, 76%, 74%, and 74%, respectively. In multivariate analysis, previous biological treatment (HR=2.01; p=0.001) was associated with a higher risk of overall recurrence. Conclusion In this study, surgery in patients with primary inflammatory ileocecal CD is associated with good postoperative outcomes, low postoperative morbidity with reasonable recurrence rates. Further studies need to validate the present results.

The Correlations between the Intensity of Histopathological Ubiquitin-Specific Protease 11 Staining and Progression of Prostate Cancer.

Ubiquitin-specific protease 11 (USP11), one of the principal phosphatase and tensin homolog (PTEN) deubiquitinases, can reserve PTEN polyubiquitination to maintain PTEN protein integrity and inhibit PI3K/AKT pathway activation. The aim of the current study was to investigate the associations between immunohistochemical USP11 staining intensities and prognostic indicators in individuals with prostate cancer. Tissue microarrays (TMAs) were performed for human prostate cancer and normal tissue (control) samples. Data on patient's age, Gleason score, plasma prostate-specific antigen (PSA) titer, disease stage, and presence of seminal vesicles, lymph nodes, and surgical margin involvement were collected. A pathologist who was blinded to the clinical outcome data scored the TMA for USP11 staining intensity as either positive or negative. Cancerous tissues exhibited lower USP11 staining intensity, whereas the neighboring benign peri-tumoral tissues showed higher USP11 staining intensity. The degree of USP11 staining intensity was lower in patients with a higher PSA titer, higher Gleason score, or more advanced disease stage. Patients who showed positive USP11 staining were more likely to have more optimal clinical and biochemical recurrence-free survival statistics. USP11 staining intensity in patients with prostate cancer is negatively associated with several prognostic factors such as an elevated PSA titer and a high Gleason score. It also reflects both biochemical and clinical recurrence-free survival in such patients. Thus, USP11 staining is a valuable prognostic factor in patients with prostate cancer.

Short and long-term outcomes of surgery for inflammatory (uncomplicated) ileocecal Crohn's disease: Multicentric retrospective analysis of 211 patients

BackgroundSurgical management for patients with inflammatory ileocecal Crohn's disease (CD) could be a reasonable alternative to second-line medical treatment. AimTo assess short and long-term outcomes of patients operated on for inflammatory, ileocecal Crohn's disease. MethodsA retrospective analysis of patients intervened at four referral hospitals during 2012–2021 was performed. Results211 patients were included. 43% of patients underwent surgery more than 5 years after diagnosis, and 49% had been exposed to at least one biologic agent preoperatively. 89% were operated by laparoscopy, with 1.6% conversion rate. The median length of the resected bowel was 25 cm (7–92) and three patients (1.43%) received a stoma. Median follow-up was 36 (17–70) months. The endoscopic recurrence-free survival proportion at 24, 48, 72, 96, and 120 months was 56%, 52%, 45%, 38%, and 33%, respectively. The clinical recurrence-free survival proportion at 24, 48, 72, 96, and 120 months was 83%, 79%, 76%, 74%, and 74%, respectively. In multivariate analysis, previous biological treatment (HR=2.01; p = 0.001) was associated with a higher risk of overall recurrence. ConclusionSurgery in patients with primary inflammatory ileocecal CD is associated with good postoperative outcomes, low postoperative morbidity with reasonable recurrence rates.

Mid-term oncologic outcomes of radical prostatectomy in lymph node metastatic prostate cancer patients.

Lymph node invasion (LNI) has been reported in 10-15% of pelvic lymph node dissection during radical prostatectomy (RP). The objective of this study was to describe the mid-term oncological outcomes in prostate cancer (PCa) patients with metastatic lymph node. We conducted a retrospective study at two French referral centers including consecutive cN0 PCa patients who underwent RP and extended pelvic lymph node dissection and had lymph node metastases on final pathological analysis (pN1) between January 2000 and May 2020. Follow-up was per institution, which generally included a PSA level measurement every 3 to 12 months for 5 years and annually thereafter. A total of 123 patients were included: two (1.6%) low-risk, 64 (52%) intermediate-risk and 57 (46.4%) high-risk PCa according to the D'Amico risk classification. The median number of nodes removed and metastatic nodes per patient was 15 (IQR 11-22) and 1 (IQR 1-2), respectively. Adverse pathological features, i.e., ≥pT3a stage, ISUP grade ≥3, and positive surgical margins were reported in 113 (91.9%), 103 (83.7%), and 73 (59%) of cases, respectively. Postoperative treatment was administered in 104 patients, including radiotherapy alone (n=6), androgen deprivation therapy alone (n=27) or combination with androgen deprivation therapy and radiotherapy (n=71). The mean follow-up was 42.7 months. The estimated 3-year biochemical-free survival, clinical recurrence-free survival, and cancer-specific survival was 66% and 85% and 98.8%, respectively. In Cox regression analysis, the number of metastatic nodes was associated with clinical recurrence (P=0.04) and a persistently elevated PSA with biochemical recurrence (P<0.001). The management of lymph node metastatic PCa patients is challenging. Risk stratification of node-positive patients, based on postoperative PSA levels and pathologic features being identified, should help physicians determine which patient would best benefit from multimodal treatment.

Comparative analysis of 10-year oncological outcomes of robot-assisted radical prostatectomy and radical retropubic prostatectomy. Experience of the Urology Clinic of the A.I. Evdokimov Moscow State University of Medicine and Dentistry

Background. Prostate cancer (PCa) is the 2nd most common oncological disease among men in the world. The first structured program of robot-assisted radical prostatectomy (RARP) was started in the year 2000. In the medical literature, a limited number of studies on long-term oncological treatment outcomes for patients with PCa after RARP is presented. In Russia, the Da Vinci robot was first installed in 2007. In the Urology Clinic of the A.I. Evdokimov Moscow State University of Medicine and Dentistry, the program of robot-assisted surgery was started in November of 2008.Aim. To perform first in Russia evaluation of 10-year oncological treatment outcomes for patients with localized PCa after RARP. To perform comparative analysis with the outcomes of radical retropubic prostatectomy (RRP).Materials and methods. Retrospective analysis of medical histories of 211 patients was performed. Among them, 62 patients did not satisfy the inclusion criteria. The remaining 149 patients were divided into 2 groups: 1st - RARP (n = 82), 2nd - RRP (n = 67). All RARP were performed by the same surgeon, RRP by 2 experienced surgeons.Results. Median follow-up was 110.35 ± 24.58 and 115.19 ± 15.37 months in the 1st and 2nd group, respectively; median follow-up was 120 months in both groups (p &gt;0.05). Survival was calculated using the Kaplan-Meyer approach. Ten-year biochemical recurrence (BCR)-free survival was 79.3 and 82.1 %, clinical recurrence-free survival was 96.3 and 97.1 %, metastasis-free survival was 92.7 and 94.0 %, cancer-specific survival was 93.9 and 95.6 % and overall survival was 85.4 and 86.6 % in the 1st and 2nd group, respectively. Mean time to BCR was 17.00 ± 20.67 and 22.83 ± 26.51 months, respectively ( p &gt;0.05). Calculation of BCR predictors was performed using correlation analysis based on contingency test and Cramer's V-test. In the 1st group, body mass index ≥30 kg/m2 (p = 0.01), prostate-specific antigen level &gt;10 ng/mL (p = 0.04), high progression risk per the D'Amico classification (p = 0.01) were independent preoperative predictors of BCR. Gleason score 7 (4 + 3) (p = 0.04) and ≥8 (p &lt;0.0001) per pathomorphological examination, pT3 stage, extraprostatic extension, invasion into the seminal vesicles and positive surgical margin (all p &lt;0.0001) were independent postoperative predictors of BCR.Conclusion. RARP demonstrates long-term (10-year) oncological effectiveness comparable to oncological effectiveness of RRP in patients with localized PCa.

MP55-20 OUTCOMES OF PRIMARY CRYOTHERAPY FOR LOCALIZED PROSTATE CANCER: 14-YEARS SINGLE INSTITUTION EXPERIENCE

You have accessJournal of UrologyCME1 May 2022MP55-20 OUTCOMES OF PRIMARY CRYOTHERAPY FOR LOCALIZED PROSTATE CANCER: 14-YEARS SINGLE INSTITUTION EXPERIENCE Andrew Wang, Greg Mansour, and Robert Given Andrew WangAndrew Wang More articles by this author , Greg MansourGreg Mansour More articles by this author , and Robert GivenRobert Given More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002634.20AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Cryoablation, a minimally invasive ablative therapy, is recommended as an alternative treatment for localized prostate cancer (PCa) given its favorable side effect profiles on bladder and bowel function, especially in those with low- and intermediate-risk disease who are not suitable for surgery or radiation therapy. Long-term outcomes are not well characterized in the literature. We aim to report our experience with the procedure at our institution. METHODS: We retrospectively reviewed all men who underwent primary whole-gland cryoablation for localized prostate cancer at our institution from 2005 through 2019. Functional and oncologic outcomes were assessed. Recurrence-free survival was studied using Kaplan-Meier survival analysis. RESULTS: Of the 276 patients, 80% had D’Amico high- (22.8%) or intermediate- (57.6%) risk disease. Average age was 71.2 years while median follow-up was 4.7 years. Majority of the patients (83%) achieved prostate-specific antigen (PSA) nadir <0.4 ng/ml. This was associated with improved disease-free survival (p <0.00001). De novo incontinence (2%) and De novo ED rates (12%) were relatively low, and complications such as urethral stricture (n=1) and rectal urethral fistula (n=0) were extremely rare. 5 year clinical recurrence-free survival was 70% overall and 94% for low-, 86% for intermediate-, and 63% for high-risk patients in our cohort. CONCLUSIONS: Primary whole-gland cryoablation is a safe and durable medium-term treatment alternative to radiation therapy and radical prostatectomy for patients with low- and intermediate risk disease. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e946 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Andrew Wang More articles by this author Greg Mansour More articles by this author Robert Given More articles by this author Expand All Advertisement PDF DownloadLoading ...

Radium-223 in patients with prostate specific antigen (PSA) progression and without clinical metastases following maximal local therapy: A pilot study.

Despite the curative intent of radical prostatectomy (RP) (+/- radiotherapy (RT)), 30% of the clinically localized prostate cancer (CaP) patients will develop rising PSA (prostate specific antigen). In absence of clinical recurrence, there is a lack of effective treatment strategies in order to control the disease at its earliest (micro)metastatic stage. The aim of this study was to assess safety, tolerability, and biochemical response of off-label Radium-223 (Xofigo) treatment in CaP patients with PSA relapse following maximal local therapy. We conducted a prospective, single arm, single center open-label, pilot study with Radium-223 in CaP patients with rising PSA (>0.2 ng/ml) following RP + adjuvant/salvage RT. Negative staging with 68Ga-PSMA-11 PET/CT and whole-body MRI was mandatory at time of inclusion. Patients were eligible if they exhibited adverse clinico-pathological features predictive of significant recurrence. Safety, tolerability, biochemical progression (defined as PSA increase >50% from PSA nadir) and clinical recurrence were assessed. In total, 23 patients were screened of whom 8 patients were included is the study. Radium-223 treatment was safe with no serious treatment related adverse events. One patient developed grade 3 lymphopenia. All patients rapidly developed PSA progression (median PSA progression-free survival: 5.5 months). Eventually all patients experienced clinical recurrence (median clinical recurrence-free survival 11.0 months) of whom only 2 patients developed skeletal recurrence. Radium-223 in patients with PSA relapse following maximal local treatment without clinical metastases is safe. However, the clinical benefit of Ra-223 in this setting is doubtful as significant oncological benefit is lacking.

The Positive Correlations between the Expression of Histopathological Ubiquitin-Conjugating Enzyme 2O Staining and Prostate Cancer Advancement.

Background: The mTOR signaling pathway is inactivated by AMPK’s tumor-suppressing function. It is recognized that ubiquitin conjugating enzyme 2O (UBE2O), which directly targets AMPK for ubiquitination and degradation, is intensified in human cancers. Methods: This study investigated the clinical data about prostate cancer. Examination was also carried out into tissue microarrays (TMA) of human prostate cancer (n = 382) and adjacent non-neoplastic tissues around prostate cancer (n = 61). The TMA slides were incubated with antibodies against UBE2O, and the cores were scored by the pathologist blind to cancer results. Results: Very strong positive correlations were identified between the expression of UBE2O staining and high PSA and pathological stage of prostate cancer. Cox’s proportional hazard analysis established correlations between the following: (1) positive surgical margin and biochemical recurrence free survival, (2) PSA grade and clinical recurrence free survival, (3) regional lymph node positive and clinical recurrence free survival, (4) adjuvant treatment and overall survival, and (5) pathological T stage and overall survival. Conclusion: There is a positive correlation between the expression of UBE2O staining and prognosis for prostate cancer. Thus, a prostate cancer prognosis can be assessed with the expression of UBE2O staining.

Plasma fibrinogen acts as a predictive factor for pathological complete response to neoadjuvant chemotherapy in breast cancer: a retrospective study of 1004 Chinese breast cancer patients

BackgroundThe aim of this study was to evaluate the relationship between pre-treatment plasma fibrinogen (Fib) level and pathological complete response (pCR) to neoadjuvant chemotherapy (NAC) in breast cancer patients and to assess the role of plasma Fib as a predictive factor.MethodsData from 1004 consecutive patients with invasive breast cancer who received NAC and subsequent surgery were retrospectively analysed. Both univariate and multivariate analyses based on logistic regression model were performed to identify clinicopathological factors associated with pCR to NAC. Cox regression model was used to determine the correlation between clinical or pathological parameters and recurrence-free survival (RFS). The Kaplan-Meier method and the log-rank test were applied in the survival analysis.ResultsThe median value of Fib, rather than other plasma coagulation parameters, was significantly increased in non-pCR patients compared with pCR patients (P = 0.002). Based on the cut-off value estimated by the receiver operating characteristic (ROC) curve analysis, patients were divided into low or high Fib groups (Fib < 3.435 g/L or ≥ 3.435 g/L). Low Fib levels were significantly associated with premenopausal or perimenopausal status (P < 0.001), tumour size ≤5 cm (P = 0.002), and positive hormone receptor status (P = 0.002). After adjusted for other clinicopathological factors in the multivariate logistic regression model, low Fib status was strongly associated with pCR to NAC (OR = 3.038, 95% CI 1.667–5.537, P < 0.001). Survival analysis showed that patients with low Fib levels exhibited better 3-year RFS compared with patients with high Fib levels in the tumour size>5 cm group (77.5% vs 58.4%, log-rank, P = 0.0168).ConclusionsThis study demonstrates that low pre-treatment plasma Fib (Fib < 3.435 g/L) is an independent predictive factor for pCR to NAC in breast cancer patients. Moreover, T3-featured breast cancer patients with lower Fib level exhibit better RFS outcomes after NAC compared with high Fib status.

External validation of genomic classifier-based risk-stratification tool to identify candidates for adjuvant radiation therapy in patients with prostate cancer.

To externally validate a Genomic Classifier (GC) based risk-stratification nomogram identifying candidates who would benefit from adjuvant radiation (aRT) therapy after radical prostatectomy (RP). We identified 350 patients who underwent RP, between 2013 and 2018, and had adverse pathological features (positive margin, and/or pT3a or higher) on final pathology. Genomic profile was available for all these men. The clinical recurrence-free survival was estimated using the Kaplan-Meier method. The external validity of the nomogram was tested using the concordance index (c-index), calibration plot, and decision curve analysis. The median follow-up of the cohort was 26.5months. Overall, 14% of the patients received aRT. During the follow-up period, 3.4% of the patients developed metastasis. Overall 3-year metastasis-free survival was 95% (95% CI 0.92-0.98). The c-index of the nomogram was 0.84. The calibration of the model was favorable. Decision-curve analysis showed a positive net benefit for probabilities ranging between 0.01 and 0.09, with the highest difference at threshold probability around 0.05. At that threshold, the net benefit is 0.06 for the model and 0 for treating all the patients. Our report is the first to confirm the validity of this genomic-based risk-stratification tool in identifying men who might benefit from aRT after RP. As such, it can be a useful instrument to be incorporated in shared decision making on whether administration of aRT will lead to a clinically meaningful benefit. Such a model can also be useful for patients' classification in future clinical trials.

Salvage Pelvic Lymph Node Dissection and Current State of Imaging for Recurrent Prostate Cancer: Does a Standard Exist?

We aim to evaluate the efficacy of salvage lymph node dissection (SLND) for nodal recurrent prostate cancer after primary treatment. We also provide a review of the diagnostic performance of next-generation sequencing (next-generation imaging (NGI)) radiotracers in the salvage setting. Most studies evaluating SLND include a heterogeneous population with a small sample size and are retrospective in design. The 5-year clinical recurrence-free and cancer-specific survival following SLND are 26-52% and 57-89%, respectively, among prospective studies. NGI improves accuracy in detecting nodal recurrence compared to conventional CT, with PMSA PET-CT showing the most promise. However, limited studies exist comparing imaging modalities and performance is variable at low PSA values. SLND is a promising treatment option, but more prospective data are needed to determine the ideal surgical candidate and long-term oncologic outcomes. More studies comparing different NGI are needed to determine the best imaging modality in patients who may be candidates for salvage treatment.

684 - External validation of genomic classifier based risk-stratification tool to identify candidates for adjuvant radiation therapy in patients with prostate cancer

To externally validate a Genomic Classifier (GC) based risk-stratification nomogram identifying candidates who would benefit from adjuvant radiation (aRT) therapy after radical prostatectomy (RP). We identified 350 patients who underwent RP, between 2013 and 2018, and had adverse pathological features (positive margin, and/or pT3a or higher) on final pathology. Genomic profile was available for all these men. The clinical recurrence-free survival was estimated using the Kaplan–Meier method. The external validity of the nomogram was tested using the concordance index (c-index), calibration plot, and decision curve analysis. The median follow-up of the cohort was 26.5 months. Overall, 14% of the patients received aRT. During the follow-up period, 3.4% of the patients developed metastasis. Overall 3-year metastasis-free survival was 95% (95% CI 0.92–0.98). The c-index of the nomogram was 0.84. The calibration of the model was favorable. Decision-curve analysis showed a positive net benefit for probabilities ranging between 0.01 and 0.09, with the highest difference at threshold probability around 0.05. At that threshold, the net benefit is 0.06 for the model and 0 for treating all the patients. Our report is the first to confirm the validity of this genomic-based risk-stratification tool in identifying men who might benefit from aRT after RP. As such, it can be a useful instrument to be incorporated in shared decision making on whether administration of aRT will lead to a clinically meaningful benefit. Such a model can also be useful for patients’ classification in future clinical trials.

Clinical value of negative 68Ga-PSMA PET/CT in the management of biochemical recurrent prostate cancer patients.

To evaluate the clinical value of 68Ga-PSMA PET/CT negativity in patients with biochemical recurrent prostate cancer (BCR). One hundred three BCR patients (median age, 70years; median PSA, 0.47ng/mL) with negative 68Ga-PSMA PET/CT, followed up for at least 1year, were retrospectively identified in a database of 1003 consecutive patients undergoing 68Ga-PSMA PET/CT for BCR. Clinical recurrence (CR) was determined or excluded on follow-up imaging selected as per clinical practice. Clinical recurrence-free survival (CRFS) was computed from the date of negative 68Ga-PSMA PET/CT to the date of evident disease; frequencies of CRFS were described as per ISUP patient subset (subset 1: ISUP grades 1 and 2; subset 2: ISUP grade 3; subset 3: ISUP grades 4 and 5) and other conventional variables. In 57 patients out of 103 (55.3%), CR was detected in the prostatic fossa (45.6%), nodes (38.6%), and bone (15.8%). The median CRFS was 15.4months (range, 12.1-20.5), with a CRFS at 12months in 61.4% of cases (range, 50.9-70.4) whereas the 24-month CRFS was 34.8% (range, 24-45.8). ISUP subset 1 benefited from significantly longer CRFS compared to subset 2 and subset 3 (median CRFS, 20.5months, 12.6months, and 12.1months, respectively). ISUP subset 3 had significantly poorer 24-month CRFS (9.3%) compared to subset 1 (47.8%) and subset 2 (33.5%). At the univariate and multivariate analyses, the ISUP subset was the only significant risk factor for clinical relapse; ISUP subset 3 and subset 2 patients held a higher risk of CR compared to subset 1 patients (HR of 2.75 [1.35-5.57] for subset 3 versus subset 1; HR of 2.08 [1.11-3.88] for subset 2 versus subset 1). 68Ga-PSMA PET/CT negativity in early BCR patients (PSA < 0.5ng/mL) with low-grade primary prostate cancer (ISUP1 and 2) may support the exploration of a clinical surveillance approach in future prospective studies.

Postoperative Endoscopic Recurrence on the Neoterminal Ileum But Not on the Anastomosis Is Mainly Driving Long-Term Outcomes in Crohn's Disease.

Early ileocolonoscopy within the first year after surgery is the gold standard to evaluate recurrence after ileocolonic resection for Crohn's disease (CD). The aim of the study was to evaluate the association between the presence and severity of anastomotic and ileal lesions at early postoperative ileocolonoscopy and long-term outcomes. The REMIND group conducted a prospective multicenter study. Patients operated for ileal or ileocolonic CD were included. An ileocolonoscopy was performed 6 months after surgery. An endoscopic score describing separately the anastomotic and ileal lesions was built. Clinical relapse was defined by the CD-related symptoms, confirmed by imaging, endoscopy or therapeutic intensification; CD-related complications; or subsequent surgery. Among 225 included patients, long-term follow-up was available in 193 (median follow-up: 3.82 years [interquartile range: 2.56-5.41]). Median clinical recurrence-free survival was 47.6 months. Clinical recurrence-free survival was significantly shorter in patients with ileal lesions at early postoperative endoscopy whatever their severity was (I(1) or I(2,3,4)) as compared to patients without ileal lesions (I(0)) (I(0) vs I(2,3,4): P = 0.0003; I(0) vs I(1): P = 0.0008 and I(1) vs I(2,3,4): P = 0.43). Patients with exclusively ileal lesions (A(0)I(1,2,3,4)) had poorer clinical long-term outcomes than patients with exclusively anastomotic lesions (A(1,2,3)I(0)) (P = 0.009). A score describing separately the anastomotic and ileal lesions might be more appropriate to define postoperative endoscopic recurrence. Our data suggest that patients with ileal lesions, including mild ones (I(1)), could beneficiate from treatment step-up to improve long-term outcomes.

The efficacy and safety of radical prostatectomy and radiotherapy in high-risk prostate cancer: A systematic review and meta-analysis.

369 Background: The optimal treatment for patients with high-risk prostate cancer (PCa) remains debate and selection of patients to receive proper therapy is still an unsettled question. This systematical review was to compare the effectiveness of prostatectomy (RP) and radiotherapy (RT) in patients with high risk prostate cancer (PCa) and to select candidates for optimal treatment. Methods: PubMed, EMBASE, and Cochrane Central Register of Controlled Trials were searched for eligible studies. We extracted hazard ratios (HRs) and 95% CI of included studies. The primary outcomes were overall survival (OS) and cancer-specific survival (CSS); the secondary outcomes were biochemical recurrence-free survival (BRFS), metastasis-free survival (MFS) and clinical recurrence-free survival (CRFS). The meta-analysis was performed using Review Manager 5.3. Subgroup analyses were conducted according to GS, T stage and RT types. Quality of life (QOL) was compared with these two treatments. Results: A total of 25 studies were included. Overall, RP showed more survival benefits than RT on CSS (P=0.003) and OS (P=0.002), while RT was associated with a better BRFS (P=0.002) and MFS (P=0.004). Subgroup analyses showed RT was associated with similar or even better survival outcomes compared to RP in patients with high GS, high T stage or received external beam radiotherapy plus brachytherapy (EBRT+BT). As for QOL, RP was associated with poorer urinary and sexual function but better performance in the bowel domain. Conclusions: RP could prolong the survival time of patients with high risk PCa; however, RT could delay disease progression, and combined RT (EBRT+BT) even brought better CSS and similar OS than RP. RT might be the prior choice for patients with high T stage or high GS. RP could lead to poorer urinary and sexual function, while brought better performance in the bowel domain.

OP04 Long-term outcomes after ileocolonic resection in Crohn’s disease according to the severity of early endoscopic recurrence

Abstract Background Early ileocolonoscopy within the first year after surgery is the gold standard to evaluate post-operative recurrence after ileocolonic resection for Crohn’s disease (CD). The aim of the study was to evaluate the association between lesions at ileocolonoscopy 6 months after surgery and long-term outcomes. Methods The REMIND group conducted a prospective multicentre study. Patients operated for ileal or ileocolonic CD were included. An ileocolonoscopy was performed 6 months after surgery. An endoscopic classification separating anastomotic and ileal lesions was built (Ax for anastomotic lesions; Ix for neo-terminal ileum lesions evaluated according to the Rutggerts score). Clinical relapse was defined by CD-related symptoms confirmed by imaging, endoscopy or therapeutic intensification, CD-related complication or subsequent surgery. Results A total of 225 patients were included. Long-term data were available for 193 patients (86%). Median follow-up was 3.82 years (IQR:2.56–5.41) from surgery. Median clinical recurrence-free survival was 47.6 months. Clinical recurrence-free survival was significantly shorter in patients with ileal lesions at early post-operative endoscopy whatever their severity (I1 or I2I3I4) compared with patients without (I0) (median survivals: 68.5, 33.0 and 39.1 months, respectively, for I0, I1 and I2I3I4; I0 vs. I2I3I4: p = 0.0003; I0 vs. I1: p = 0.0008 and I1 vs. I2I3I4: p = 0.43). Patients with at least semi-circumferential anastomotic ulcerations (A2 or A3) had more anastomotic occlusive manifestations than patients without (A0 or A1) (A0 vs. A2A3: p = 0.01; A0 vs. A1: p = 0.83; A1 vs. A2A3: p = 0.05). Conclusion A classification separating anastomotic and ileal lesions might be more appropriate to define post-operative endoscopic recurrence. Patients with ileal lesions, including mild ones (I1), could beneficiate from treatment step up to improve long-term outcome.