Candidates For Radical Prostatectomy Research Articles

A randomized phase I/II study of neoadjuvant treatment with 177-Lutetium-PSMA-617 with or without ipilimumab in patients with very high-risk prostate cancer who are candidates for radical prostatectomy (NEPI trial).

TPS352 Background: High-risk prostate cancer accounts for approximately 15% of newly diagnosed prostate cancers. For patients with high-risk, locally advanced prostate cancer, prostatectomy alone may be insufficient therapy. Cure rates from radical prostatectomy alone are less than 25%. Ipilimumab increases overall survival in men with post-docetaxel mCRPC who received radiotherapy to bone metastases followed by ipilimumab in comparison to placebo. Final results of the VISION trial (NCT03511664), a phase III study designed to assess the efficacy of [177Lu]Lu-PSMA-617 in patients with PSMA-positive mCRPC, show a significant prolongation of survival in a setting without established therapy. Since both ipilimumab combined with radiation and [177Lu]Lu-PSMA-617 have been proven to be effective in the treatment of mCRPC, we hypothesize, that CTLA-4-inhibitors exert synergistic effects on [177Lu]Lu-PSMA-617 RLT-induced tumor damage and immune priming. Methods: Patients diagnosed with highest risk prostate cancer (ISUP-GG 4+5 and cT3 plus cN+ or PSA > 20ng/ml) who are candidates for radical prostatectomy receive 12 weeks of neoadjuvant treatment with ADT plus [177Lu]Lu-PSMA-617 (LuPSMA) with randomized allocation with or without ipilimumab. Prior to initiation of the randomized set, we will conduct a Safety-Run-In-Phase. The initial 3-6 patients will receive a reduced dose of 3.7 Gb [177Lu]Lu-PSMA-617 and 3 mg/kg Ipilimumab, which will be increased to the target dose of 7.4Gb [177Lu]Lu-PSMA-617 and 3 mg/kg Ipilimumab in the following 3-6 patients if sufficiently well tolerated. The safety and feasibility of the combination will be assessed after 6-12 patients based on toxicity or delay of prostatectomy (max. 3 weeks). In the absence of serious toxicity signals a total of 46 patients will be randomized 1:1 (ipilimumab + ADT + LuPSMA vs. ADT + LuPSMA) to receive 2 cycles of 7.4 GBq LuPSMA with or without 4 cycles of ipilimumab 3mg/kg prior to prostatectomy. Scheduled Imaging with mpMRI and PSMA PET CT is performed prior to neoadjuvant therapy and prior to radical prostatectomy. Co-primary endpoints of the study are feasibility of radical prostatectomy after neoadjuvant therapy, and complete pathologic response. Secondary endpoints are evaluation of the safety profile of neoadjuvant treatment according to "National Cancer Institute Common Terminology Criteria for Adverse Events" (NCI CTCAE) v5.0 and disease-free survival. Enrollment of the first patient in NEPI Trial is expected to be completed in late September 2023. A total of up to 3 German centers will participate. Clinical trial information: EudraCT-Nr.: 2021-004894-30.

A novel assessment of whole-mount Gleason grading in prostate cancer to identify candidates for radical prostatectomy: a machine learning-based multiomics study

A novel assessment of whole-mount Gleason grading in prostate cancer to identify candidates for radical prostatectomy: a machine learning-based multiomics study

PE022 - Comparison of four validated nomograms (Memorial Sloan Kettering Cancer Center, Briganti 2012, 2017, and 2019) predicting lymph node invasion in patients with high-risk prostate cancer candidates for radical prostatectomy and extended pelvic lymph node di

PE022 - Comparison of four validated nomograms (Memorial Sloan Kettering Cancer Center, Briganti 2012, 2017, and 2019) predicting lymph node invasion in patients with high-risk prostate cancer candidates for radical prostatectomy and extended pelvic lymph node di

MP67-04 VALIDATION OF NOVEL PREOPERATIVE RISK CATEGORIES ON THE PREDICTION OF CLINICAL RECURRENCE IN PATIENTS CANDIDATE FOR RADICAL PROSTATECTOMY FOR CLINICALLY LOCALIZED PROSTATE CANCER. RESULTS OF A LARGE, MULTI-INSTITUTIONAL SERIES

You have accessJournal of UrologyCME1 Apr 2023MP67-04 VALIDATION OF NOVEL PREOPERATIVE RISK CATEGORIES ON THE PREDICTION OF CLINICAL RECURRENCE IN PATIENTS CANDIDATE FOR RADICAL PROSTATECTOMY FOR CLINICALLY LOCALIZED PROSTATE CANCER. RESULTS OF A LARGE, MULTI-INSTITUTIONAL SERIES Elio Mazzone, Giorgio Gandaglia, Francesco Barletta, Andrea Necchi, Daniele Raggi, Laura Marandino, Armando Stabile, Vito Cucchiara, Giuseppe Rosiello, Gabriele Sorce, Francesco Pellegrino, Simone Scuderi, Daniele Robesti, Mario De Angelis, Antony Pellegrino, Mattia Longoni, Pietro Scilipoti, Francesco Montorsi, and Alberto Briganti Elio MazzoneElio Mazzone More articles by this author , Giorgio GandagliaGiorgio Gandaglia More articles by this author , Francesco BarlettaFrancesco Barletta More articles by this author , Andrea NecchiAndrea Necchi More articles by this author , Daniele RaggiDaniele Raggi More articles by this author , Laura MarandinoLaura Marandino More articles by this author , Armando StabileArmando Stabile More articles by this author , Vito CucchiaraVito Cucchiara More articles by this author , Giuseppe RosielloGiuseppe Rosiello More articles by this author , Gabriele SorceGabriele Sorce More articles by this author , Francesco PellegrinoFrancesco Pellegrino More articles by this author , Simone ScuderiSimone Scuderi More articles by this author , Daniele RobestiDaniele Robesti More articles by this author , Mario De AngelisMario De Angelis More articles by this author , Antony PellegrinoAntony Pellegrino More articles by this author , Mattia LongoniMattia Longoni More articles by this author , Pietro ScilipotiPietro Scilipoti More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , and Alberto BrigantiAlberto Briganti More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003330.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Most of the preoperative risk tools predicting prostate cancer (PCa) recurrence after radical prostatectomy (RP) considered biochemical recurrence (BCR) as the main endpoint when developed. However, not all patients with a BCR ultimately progress to clinical recurrence (CR). We aimed at internally validating a novel preoperative risk classification in predicting CR in patients treated with RP. METHODS: Overall, 2,901 patients treated with RP and who received pre-op mpMRI between 2014 -2022 at eight referral centers were identified. The study outcome was 5-yr CR defined as positive imaging after BCR. Kaplan-Meier and multivariable Cox regression models tested time and predictors of CR. Predictors consisted of PSA, biopsy grade group, MRI stage (organ-confined vs extracapsular extension vs. seminal vesicles invasion) and maximum diameter of lesion at MRI. These variables defined four risk groups based on the novel classification. The tool accuracy was compared to the EAU risk classification and CAPRA score in predicting 5-year CR using Harrel’s c-index. Decision curve analyses (DCA) compared the net-benefit associated with each of the risk tools. RESULTS: Overall, 937 (32%), 1006 (35%), 848 (30%) and 110 (3%) had low, intermediate, high and very-high risk disease according to the novel classification. Median follow-up was 43 months. At KM analyses, 5-year CR-free survival rates were 94, 90, 83 and 71% in, respectively, low, intermediate, high and very-high risk groups (p<0.01). The novel model tested for prediction CR in Cox regression analyses depicted good discrimination at internal validation (c-index 76%). After testing the accuracy of the EAU risk groups and the CAPRA score in our cohort, the novel model showed higher c index (78 vs. 69 vs. 73%). At DCA, our novel model showed a higher net-benefit compared to other models (Figure 1). CONCLUSIONS: We internally validated a novel preoperative risk tool to predict CR after RP. Our model exhibited higher accuracy as compared to available tools in the prediction of stronger oncologic endpoints at mid-term follow-up. This data reinforces the utility of this patient stratification for preoperative counselling and outcome predictions. Source of Funding: no © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e944 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Elio Mazzone More articles by this author Giorgio Gandaglia More articles by this author Francesco Barletta More articles by this author Andrea Necchi More articles by this author Daniele Raggi More articles by this author Laura Marandino More articles by this author Armando Stabile More articles by this author Vito Cucchiara More articles by this author Giuseppe Rosiello More articles by this author Gabriele Sorce More articles by this author Francesco Pellegrino More articles by this author Simone Scuderi More articles by this author Daniele Robesti More articles by this author Mario De Angelis More articles by this author Antony Pellegrino More articles by this author Mattia Longoni More articles by this author Pietro Scilipoti More articles by this author Francesco Montorsi More articles by this author Alberto Briganti More articles by this author Expand All Advertisement PDF downloadLoading ...

MP67-16 SURGICAL OUTCOMES IN PATIENTS RECEIVING NEOADJUVANT VACCINE THERAPY (PROSTVAC) PRIOR TO RADICAL PROSTATECTOMY: A PHASE II EXPERIENCE

You have accessJournal of UrologyCME1 Apr 2023MP67-16 SURGICAL OUTCOMES IN PATIENTS RECEIVING NEOADJUVANT VACCINE THERAPY (PROSTVAC) PRIOR TO RADICAL PROSTATECTOMY: A PHASE II EXPERIENCE Zoe Blake, Daniel Nemirovsky, Alexander Kenigsberg, Neil Mendhiratta, Jacob Enders, Michael Rothberg, Daniel Nethala, Baris Turkbey, Bradford Wood, Sandeep Gurram, Howard Parnes, James Gulley, and Peter Pinto Zoe BlakeZoe Blake More articles by this author , Daniel NemirovskyDaniel Nemirovsky More articles by this author , Alexander KenigsbergAlexander Kenigsberg More articles by this author , Neil MendhirattaNeil Mendhiratta More articles by this author , Jacob EndersJacob Enders More articles by this author , Michael RothbergMichael Rothberg More articles by this author , Daniel NethalaDaniel Nethala More articles by this author , Baris TurkbeyBaris Turkbey More articles by this author , Bradford WoodBradford Wood More articles by this author , Sandeep GurramSandeep Gurram More articles by this author , Howard ParnesHoward Parnes More articles by this author , James GulleyJames Gulley More articles by this author , and Peter PintoPeter Pinto More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003330.16AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: PROSTVAC is a therapeutic cancer vaccine designed to activate T cells specific against prostate-specific antigen (PSA). Previous trials have shown PROSTVAC to be safe and capable of modulating immune responses in patients with localized prostate cancer (PCa). We aim to examine the surgical safety and feasibility outcomes of patients in a phase II trial (NCT02153918) investigating the neoadjuvant use of this vaccine therapy in patients with localized PCa. METHODS: An open-label, phase II study of neoadjuvant PROSTVAC vaccine enrolled patients with histopathologically confirmed localized PCa who were surgical candidates for radical prostatectomy (RP). Patients received recombinant vaccinia (rV)-PSA(L155)-TRICOM (PROSTVAC) as a priming vaccination, followed by monthly boosts on weeks 5, 9 and 13 with recombinant fowlpox (rF)-PROSTVAC. The boosting schedule was amended mid-trial to weeks 3, 5 and 9 to allow for earlier surgeries. After completing the vaccination series, patients underwent RP at week 10. Final follow-up safety evaluation was performed 12–15 months postoperatively. RESULTS: Between 2014-2016, 26 of 27 enrolled patients went on to receive RP. On pre-RP biopsy, 12/26 (46.2%) of patients had Gleason grade group (GG) 1-2, and 14/26 (53.8%) of patients had GG 3-5 (Table 1). Two patients (7.7%) were upgraded, and five (19.2%) downgraded on final pathology. Rates of adverse features at RP are shown in Table 2. The most common adverse event (AE) was a self-limited injection-site reaction (28 events in 18 patients), and no serious AEs or toxicities>grade 2 were attributed to PROSTVAC. However, two grade 3 serious AEs occurred: an infected lymphocele and a thromboembolic event, both attributed to surgery. CONCLUSIONS: PROSTVAC was well tolerated and demonstrated the feasibility of neoadjuvant vaccination strategies for localized PCa. Further studies will be needed to elucidate the effectiveness of this vaccine therapy on short and long-term oncologic outcomes. Source of Funding: NIH intramural research program © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e949 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Zoe Blake More articles by this author Daniel Nemirovsky More articles by this author Alexander Kenigsberg More articles by this author Neil Mendhiratta More articles by this author Jacob Enders More articles by this author Michael Rothberg More articles by this author Daniel Nethala More articles by this author Baris Turkbey More articles by this author Bradford Wood More articles by this author Sandeep Gurram More articles by this author Howard Parnes More articles by this author James Gulley More articles by this author Peter Pinto More articles by this author Expand All Advertisement PDF downloadLoading ...

Comparison of Four Validated Nomograms (Memorial Sloan Kettering Cancer Center, Briganti 2012, 2017, and 2019) Predicting Lymph Node Invasion in Patients with High-Risk Prostate Cancer Candidates for Radical Prostatectomy and Extended Pelvic Lymph Node Dissection: Clinical Experience and Review of the Literature.

The indication for extended pelvic lymph node dissection (ePLND) at the time of radical prostatectomy (RP) is based on nomograms predicting the risk of lymph node invasion (LNI). However, limited data are available on the comparison of these predictive models in high-risk prostate cancer (PC) patients. Therefore, we compared the accuracy of the most used nomograms (MSKCC, Briganti 2012, 2017, and 2019) in the setting of high-risk PC patients submitted to ePLND. 150 patients with high-risk PC disease treated from 2019 to 2022 were included. Before RP + ePLND, we assessed the MSKCC, Briganti 2012, 2017, and 2019 nomograms for each patient, and we compared the prediction of LNI with the final histopathological analysis of the ePLND using pathologic results as a reference. LNI was found in 39 patients (26%), and 71.3% were cT2. The percentage of patients with estimated LNI risk above the cut-off was significantly higher in pN+ cases than in pN0 for all Briganti nomograms. The percentage of patients at risk of LNI, according to Briganti Nomogram (2012, 2017, and 2019), was significantly higher in pN+ cases than in pN0 (p < 0.04), while MSKCC prediction didn't vary significantly between pN0 and pN+ groups (p = 0.2). All nomograms showed high sensitivity (Se > 0.90), low specificity (Sp < 0.20), and similar AUC (range: 0.526-0.573) in predicting pN+. Particularly, 74% of cases patients with MSKCC estimated risk > 7% showed pN0 compared to 71% with Briganti 2012 > 5%, 69% with Briganti 2017 > 7%, and 70% with Briganti 2019 > 7%. Despite the high-risk disease, in our patients treated with ePLND emerges a still high number of pN0 cases and a similar low specificity of nomograms in predicting LNI.

Which men with cN1 prostate cancer at PSMA PET/CT represent the ideal candidate for radical prostatectomy? Development of a novel risk stratification tool for individualized approaches based on a large, multi-institutional series

Which men with cN1 prostate cancer at PSMA PET/CT represent the ideal candidate for radical prostatectomy? Development of a novel risk stratification tool for individualized approaches based on a large, multi-institutional series

Prospective evaluation of the diagnostic accuracy of different PSMA PET/CT tracers for the nodal staging of radical prostatectomy candidates: A single institutional analysis

Prospective evaluation of the diagnostic accuracy of different PSMA PET/CT tracers for the nodal staging of radical prostatectomy candidates: A single institutional analysis

Expanding Active Surveillance Criteria for Low- and Intermediate-risk Prostate Cancer: Can We Accurately Predict the Risk of Misclassification for Patients Diagnosed by Multiparametric Magnetic Resonance Imaging–targeted Biopsy?

Models predicting the risk of adverse pathology (ie, International Society of Urological Pathology [ISUP] grade group ≥3, pT3, and/or pN1) among patients operated by radical prostatectomy (RP) have been proposed to expand active surveillance (AS) inclusion criteria. We aimed to test these models in a set of 1062 low-risk and favorable intermediate-risk prostate cancer (PCa) patients diagnosed by multiparametric magnetic resonance imaging (MRI) and MRI-targeted biopsy. We hypothesized that the inclusion of radiological features into a novel model would improve patient selection. Performance was assessed using discrimination, calibration, and decision curve analysis (DCA). Available models were characterized by poor discrimination (areas under the receiver operating characteristic curve [AUCs] of 59% and 60%), underestimation of predicted risk on calibration plots, and a small amount of net benefit against a probability threshold of 40–50% at the DCA. The development of a novel model slightly improved discrimination (AUC of 63% vs 59%, p = 0.001, and 63% vs 60%, p = 0.07) and net benefit against threshold probabilities of ≥30%. This first multicenter study demonstrated the poor performance of models predicting adverse pathology and that implementation of MRI and MRI-targeted biopsy in this setting was not associated with a clear improvement in patient selection. Patients harboring low-risk or favorable intermediate-risk PCa and candidates for RP cannot be referred accurately to an AS program without a non-negligible risk of misclassification. Patient summaryWe tested prediction models that could expand the selection of prostate cancer patients for active surveillance. Models were inaccurate and associated with a high risk of misclassification despite the implementation of multiparametric magnetic resonance imaging and targeted biopsies.

SC168 - Predictive role of node-rads score in patients with prostate cancer candidates for radical prostatectomy with extended lymph node dissection: comparative analysis with validated nomograms

SC168 - Predictive role of node-rads score in patients with prostate cancer candidates for radical prostatectomy with extended lymph node dissection: comparative analysis with validated nomograms

Reply to Veerman et al. Comment on "Rosenzweig et al. Very Low Prostate PET/CT PSMA Uptake May Be Misleading in Staging Radical Prostatectomy Candidates. J. Pers. Med. 2022, 12, 410".

We thank the commenters for their important insights [...].

Comment on Rosenzweig et al. Very Low Prostate PET/CT PSMA Uptake May Be Misleading in Staging Radical Prostatectomy Candidates. J. Pers. Med. 2022, 12, 410.

With interest, we read the article by Rosenzweig et al. [...].

Very Low Prostate PET/CT PSMA Uptake May Be Misleading in Staging Radical Prostatectomy Candidates.

Purpose: to evaluate a unique subpopulation of radical prostatectomy (RP) candidates with “negative” prostate 68Ga-labeled prostate-specific membrane antigen (PSMA) positron emission tomography (PET) computed tomography (CT) imaging scans and to characterize the clinical implications of misleading findings. Materials and Methods: This case-control retrospective study compared the final histological outcomes of patients with “negative” pre-RP PSMA PET/CT prostate scans (with a prostate maximal standardized uptake value [SUVmax] below the physiologic uptake) to those with an “intense” prostatic tracer uptake (with a SUVmax above the physiologic uptake). The patients underwent an RP between March 2015 and July 2019 in five academic centers. Data on the demographics, comorbidities, prostate-specific antigen (PSA) and rectal exam findings, prior biopsies, imaging results, biopsies, and RP histology results were collected. Results: Ninety-seven of the 392 patients who underwent an RP had PSMA PET/CT imaging preoperatively. Fifty-two (54%) had a “negative” uptake (in the study group), and 45 (46%) had a “positive” uptake (in the control group). Only the lesion size and SUVmax values on the PSMA PET/CT differed between the groups preoperatively. On the histological analysis, only the ISUP score, seminal vesicles invasion, T stage, and positive margin rates differed between the groups (p < 0.05), while 50 (96%) study group patients harbored clinically significant disease (ISUP ≥ 2), with an extra-prostatic disease in 24 (46%), perineural invasion in 35 (67%), and positive lymph nodes in 4 (8%). Conclusions: Disease aggressiveness generally correlated with an intense PSMA uptake on the preoperative PSMA PET/CT, but a subpopulation of patients with clinically significant cancer and aggressive characteristics showed a deceptively weak PSMA uptake. These data raise a concern about the unqualified application of PSMA PET/CT for staging RP candidates.

PROTEUS: A randomized, double-blind, placebo (PBO)-controlled, phase 3 trial of apalutamide (APA) plus androgen deprivation therapy (ADT) versus PBO plus ADT prior to radical prostatectomy (RP) in patients (pts) with localized or locally advanced high-risk prostate cancer (PC).

TPS285 Background: In pts with localized high-risk PC, disease recurrence rate following RP is ̃50% (Kane et al. J Urol. 2007). Treatment (tx) with androgen blockade before RP can reduce tumor burden post RP (Taplin et al. J Clin Oncol. 2014; McKay et al. Prostate Cancer Prostatic Dis. 2018; Efstathiou et al. Eur Urol. 2019). This study examines if 12 months of perioperative APA + ADT tx before and after RP with pelvic lymph node dissection (pLND) in localized/locally advanced high-risk PC improves pathologic complete response (pCR) rate and metastasis-free survival (MFS) vs PBO + ADT. Methods: PROTEUS, an international multicenter study, is enrolling ̃2000 pts with localized/locally advanced high-risk/very high-risk PC who are candidates for RP with pLND over 3 years at &gt; 203 sites in 18 countries. Stratification variables: Gleason score (7 vs ≥ 8), pelvic node status (N0 vs N1), international region. Randomization: 1:1 to APA (240 mg/d) + ADT or PBO + ADT. Pts receive 6-month neoadjuvant tx followed by RP and then 6 months’ adjuvant tx. Primary end points: pCR rate and MFS. In addition to MFS based on conventional imaging, MFS based on PSMA PET or conventional imaging will be assessed as a separate end point. Both pCR and MFS are assessed by blinded independent central review. Conventional imaging by CT or MRI and bone scan are done at screening, within 4 weeks after RP, at biochemical failure (BCF), and then every 6 months after BCF until distant metastasis or death. During the direct perioperative period, APA/PBO is stopped 2 weeks prior to planned RP and then resumed 4 weeks after RP if post-RP imaging has been conducted to assess for lymphocele and disease progression and resolution to grade ≤ 1 of any clinically significant adverse events considered related to RP. To reflect evolving standard of care, the following protocol amendments were added: PSMA-PET imaging at 3 months post adjuvant tx, at BCF, and every 6 months until distant metastasis or death; cardiovascular and thrombotic risk assessment at screening, prior to, and after RP; and guidance for standard thrombotic prophylaxis in the perioperative setting. An independent data monitoring committee will review trial data. Clinical trial information: NCT03767244.

SC282 - PET/CT allows for a reliable assessment of the real nodal burden in clinically node-positive prostate cancer patients candidate for radical prostatectomy: results from a multi-institutional series

SC282 - PET/CT allows for a reliable assessment of the real nodal burden in clinically node-positive prostate cancer patients candidate for radical prostatectomy: results from a multi-institutional series

EDITORIAL COMMENT

In this interesting study, an automatically calculated electronic comorbidity measure, the Care Assessment Needs (CAN) score, was studied as predictor of life expectancy in a huge Veterans Health Administration (VHA) patient sample. 1 N. N. et al. Using an automated electronic health record score to estimate life expectancy in men diagnosed with prostate cancer in the Veterans Health Administration. Urology. 2021; ([in press]) Google Scholar The score was originally designed to estimate short-term risks of hospitalization and mortality. The authors demonstrated a strong association of the CAN score with medium-term mortality after prostate cancer diagnosis. 1 N. N. et al. Using an automated electronic health record score to estimate life expectancy in men diagnosed with prostate cancer in the Veterans Health Administration. Urology. 2021; ([in press]) Google Scholar Although this instrument may be automatically available in VHA patients, its high complexity may hinder its routine use in different institutions. Instruments predicting life expectancy to support treatment selection in men with early prostate cancer should not only be accurate but also simple to use. 2 Daskivich TJ Kwan L Dash A et al. Weighted versus unweighted Charlson score to predict long-term other-cause mortality in men with early-stage prostate cancer. Eur Urol. 2014; 66: 1002-1009 Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar In contrast to some contrary claims, 3 Walz J Gallina A Perrotte P et al. Clinicians are poor raters of life-expectancy before radical prostatectomy or definitive radiotherapy for localized prostate cancer. BJU Int. 2007; 100: 1254-1258 Crossref PubMed Scopus (113) Google Scholar at least in candidates for radical prostatectomy, clinicians are probably able raters of life expectancy. In our radical prostatectomy series, even patients with the highest risk of competing mortality (age-adjusted Charlson score of 6 or higher, comprising only 4% of the sample) had a 10-year non-prostate cancer mortality rate of only 40% 4 Froehner M. Patient reported vs claims based measures of health for modeling life expectancy in men with prostate cancer. Letter. J Urol. 2021; 205: 1235-1236 Crossref Scopus (1) Google Scholar and the 50% level was not reached before narrowly 14 years. Complex tools requiring comprehensive data collection will probably not change routine decision making in candidates for radical prostatectomy regardless of their accuracy. If the risk classifications were, however, automatically calculated and readily available, there may be a different situation. Because of the huge sample size and the detailed information collected, the impressive data source used in this study 1 N. N. et al. Using an automated electronic health record score to estimate life expectancy in men diagnosed with prostate cancer in the Veterans Health Administration. Urology. 2021; ([in press]) Google Scholar should encourage further studies, for instance predicting 90-day mortality in vulnerable candidates for radical cystectomy.

PD05-09 PET/CT ALLOWS FOR A RELIABLE ASSESSMENT OF THE REAL NODAL BURDEN IN CLINICALLY NODE-POSITIVE PROSTATE CANCER PATIENTS CANDIDATE FOR RADICAL PROSTATECTOMY: RESULTS FROM A MULTI-INSTITUTIONAL SERIES

You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) I (PD05)1 Sep 2021PD05-09 PET/CT ALLOWS FOR A RELIABLE ASSESSMENT OF THE REAL NODAL BURDEN IN CLINICALLY NODE-POSITIVE PROSTATE CANCER PATIENTS CANDIDATE FOR RADICAL PROSTATECTOMY: RESULTS FROM A MULTI-INSTITUTIONAL SERIES Giorgio Gandaglia, R. Jeffrey Karnes, Charlien Berghen, Wouter Everaerts, Gaëtan Devos, Steven Joniau, Daniele Robesti, Armando Stabile, Simone Scuderi, Francesco Barletta, Vito Cucchiara, Elio Mazzone, Giuseppe Rosiello, Andrea Salonia, Pierre I Karakiewicz, Hendrik Van Poppel, Francesco Montorsi, and Alberto Briganti Giorgio GandagliaGiorgio Gandaglia More articles by this author , R. Jeffrey KarnesR. Jeffrey Karnes More articles by this author , Charlien BerghenCharlien Berghen More articles by this author , Wouter EveraertsWouter Everaerts More articles by this author , Gaëtan DevosGaëtan Devos More articles by this author , Steven JoniauSteven Joniau More articles by this author , Daniele RobestiDaniele Robesti More articles by this author , Armando StabileArmando Stabile More articles by this author , Simone ScuderiSimone Scuderi More articles by this author , Francesco BarlettaFrancesco Barletta More articles by this author , Vito CucchiaraVito Cucchiara More articles by this author , Elio MazzoneElio Mazzone More articles by this author , Giuseppe RosielloGiuseppe Rosiello More articles by this author , Andrea SaloniaAndrea Salonia More articles by this author , Pierre I KarakiewiczPierre I Karakiewicz More articles by this author , Hendrik Van PoppelHendrik Van Poppel More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , and Alberto BrigantiAlberto Briganti More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001969.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: PET/CT scan might identify nodal metastases in prostate cancer (PCa) patients considered for radical prostatectomy (RP). No data addressed the performance characteristics and prognostic value of a positive PET/CT in the nodes for the identification of men more likely to recur METHODS: 346 patients treated with RP and an extended lymph node dissection (LND) with pelvic or retroperitoneal lymphadenopathies at cross-sectional abdominal imaging (n=283 81.8%) vs. choline or PSMA PET/CT (n=63 18.2%) were identified. Lowess analyses explored the non-linear relationship between the number of positive spots and pathologically positive nodes according to imaging (cross-sectional vs PET/CT). Kaplan-Meier analyses assessed time to biochemical recurrence (BCR) in the PET/CT cohort after stratifying patients according to the number of lymphadenopathies. The best cut-off for the number of lymphadenopathies at PET/CT predicting BCR was determined RESULTS: The rate of pN1 disease (74 vs 69%), the number of nodes removed (25 vs 24) and of positive nodes (2 vs 2) at LND did not differ (all P≥0.2). The site of lymphadenopathies was the pelvis only and the pelvis ± retroperitoneum in 84 vs. 88% and 16 vs 12% patients (p=0.3). Cross-sectional imaging was associated with underestimation of nodal burden when ≥2 lymphadenopathies were detected. PET/CT was characterized by excellent concordance with the number of positive nodes at RP. Median follow-up was 70 months and 183 patients experienced BCR. For PET/CT, the most-informative cut-off predicting BCR was 2 clinical lymphadenopathies. When patients selected based on PET/CT were stratified according to the number of positive spots (1 vs ≥2), the 3-year BCR-free survival rates were 48 vs. 21% (p=0.03). This was consistent to what observed when stratifying patients according to the number of positive nodes at final pathology (41 vs 23% p=0.04) CONCLUSIONS: While conventional imaging underestimates the nodal burden, PET/CT is characterized by excellent concordance with final pathology. This resulted in a more reliable prediction of BCR, where the presence of ≥2 positive spots at PET/CT might identify men more likely to experience early recurrence. Source of Funding: - © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e58-e59 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Giorgio Gandaglia More articles by this author R. Jeffrey Karnes More articles by this author Charlien Berghen More articles by this author Wouter Everaerts More articles by this author Gaëtan Devos More articles by this author Steven Joniau More articles by this author Daniele Robesti More articles by this author Armando Stabile More articles by this author Simone Scuderi More articles by this author Francesco Barletta More articles by this author Vito Cucchiara More articles by this author Elio Mazzone More articles by this author Giuseppe Rosiello More articles by this author Andrea Salonia More articles by this author Pierre I Karakiewicz More articles by this author Hendrik Van Poppel More articles by this author Francesco Montorsi More articles by this author Alberto Briganti More articles by this author Expand All Advertisement Loading ...

Time Trends in Use of Radical Prostatectomy by Tumor Risk and Life Expectancy in a National Veterans Affairs Cohort

Guidelines endorse using tumor risk and life expectancy (LE) to select appropriate candidates for radical prostatectomy (RP), recommending against treatment of most low-risk tumors and men with limited LE. To investigate time trends in the use of RP by tumor risk and Prostate Cancer Comorbidity Index (PCCI) score in a contemporary, nationally representative Veterans Affairs (VA) cohort. This cohort study of 5736 men treated with RP at 8 VA hospitals from January 1, 2000, to December 31, 2017, used a nationally representative, multicenter sample from the VA SEARCH (Shared Equal Access Regional Cancer Hospital) database. Statistical analysis was performed from June 30, 2018, to August 20, 2020. Stratified linear and log-linear Poisson regressions were used to estimate time trends in the proportion of men treated with RP across American Urological Association tumor risk and PCCI (a validated predictor of LE based on age and comorbidities) subgroups. Among 5736 men (mean [SD] age at surgery, 62 [6] years) treated with RP from 2000 to 2017, the proportion of low-risk tumors treated with RP decreased from 51% to 7% (difference, -44%; 95% CI, -50% to -38%). The proportion of intermediate-risk tumors treated with RP increased from 30% to 59% (difference, 29%; 95% CI, 23%-35%), with unfavorable intermediate-risk tumors increasing from 30% to 41% (difference, 11%; 95% CI, 4%-18%) and favorable intermediate-risk tumors decreasing from 61% to 41% (difference, -20%; 95% CI, -24% to -15%). The proportion of high-risk tumors treated with RP increased from 18% to 33% (difference, 15%; 95% CI, 9%-21%). Among men treated with RP, the proportion with the highest PCCI scores of 10 or more (ie, LE <10 years) increased from 4% to 13% (difference, 9%; 95% CI, 4%-14%). Within each tumor risk subgroup, no significant difference in the rate of tumors treated with RP over time was found across PCCI subgroups. In this study, the use of RP shifted from low-risk and favorable intermediate-risk to higher-risk prostate cancer. However, its use among men with limited LE appears unchanged across tumor risk subgroups and increased overall.

Couple Counseling and Pelvic Floor Muscle Training for Men Operated for Prostate Cancer and for Their Female Partners: Results From the Randomized ProCan Trial.

IntroductionPatients with prostate cancer (PC) who undergo radical prostatectomy (RP) experience impaired sexual and urinary function.AimTo compare the effect of early couple counseling and pelvic floor muscle training (PFMT) with usual care for sexual and urinary dysfunction after RP.MethodsThe ProCan study was a randomized controlled trial (RCT) with two parallel treatment arms and 1:1 allocation. Between January 2016 and December 2017, candidates for RP were invited to a longitudinal questionnaire study and provided baseline measures before surgery. Patients who underwent RP, had a female partner, and were sexually active were invited to the ProCan RCT. Couples who provided informed consent were allocated to usual care or usual care and up to six couple counseling sessions, up to three instructions in PFMT and a video home-training program. All couples filled in follow-up questionnaires at 8 and 12 months and non-participants provided 12 months’ follow-up. Linear mixed-effect models and 95% confidence intervals were used to measure effects of the intervention.Main Outcome MeasurePrimary outcome was erectile function, measured with The International Index of Erectile Function, at 8 and 12 months follow-up. Secondary outcomes were sexual and urinary function and use of treatment for erectile dysfunction (ED) by patients; sexual function in female partners; and relationship function, health-related quality of life, anxiety, depression, and self-efficacy in both patients and female partners.ResultsThirty-five couples were randomized. No significant effect of the intervention was found on erectile function at 8 months (estimated difference in change, 1.41; 95% CI; –5.51 ; 8.33) or 12 months (estimated difference in change, 0.53; 95% CI; –5.94; 6.99) or in secondary outcomes, except for significantly increased use of ED treatment at 8 months.ConclusionWe found no effect of early couple counseling and PFMT, possibly because of the limited number of participants. Karlsen RV, Bidstrup PE, Giraldi A, et al. Couple Counseling and Pelvic Floor Muscle Training for Men Operated for Prostate Cancer and for Their Female Partners. Results From the Randomized ProCan Trial. Sex Med 2021;9:100350.

P0924 - PET/CT allows for a reliable assessment of the real nodal burden in clinically node-positive prostate cancer patients candidate for radical prostatectomy: Results from a multi-institutional series

P0924 - PET/CT allows for a reliable assessment of the real nodal burden in clinically node-positive prostate cancer patients candidate for radical prostatectomy: Results from a multi-institutional series