Pub Date : 2025-02-05DOI: 10.1016/j.euo.2025.01.010
Bertrand Tombal, Yohann Loriot
{"title":"Reply to Francesco Montorsi, Giorgio Gandaglia, Francesco Barletta, and Alberto Briganti's Letter to the Editor re: Bertrand F. Tombal, Francisco Gomez-Veiga, Alvaro Gomez-Ferrer, et al. A Phase 2 Randomized Open-label Study of Oral Darolutamide Monotherapy Versus Androgen Deprivation Therapy in Men with Hormone-sensitive Prostate Cancer (EORTC-GUCG 1532). Eur Urol Oncol 2024;7:1051-60.","authors":"Bertrand Tombal, Yohann Loriot","doi":"10.1016/j.euo.2025.01.010","DOIUrl":"https://doi.org/10.1016/j.euo.2025.01.010","url":null,"abstract":"","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143363920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-05DOI: 10.1016/j.euo.2025.01.006
Anna Patrikidou, Christoph Oing, Christos Markellos, Axel Heidenreich, Ricardo Leao, Nicola Nicolai, Joost Boormans, Stefanie Fischer, Christian Fankhauser, Walter Cazzaniga, Patrizia Giannatempo, Daniel Berney, Hendrik Gremmels, Robert Cornes, Florian Janisch, Domenico Di Nardo, Alexandros Papachristofilou, Karim Fizazi, Togrim Tandstad, David Nicol, Robert Huddart
The 2021 updated International Germ Cell Cancer Collaborative Group classification for seminomatous germ cell tumours confirmed and refined the original classification, introducing the notion that lactate dehydrogenase (LDH) elevation above 2.5 times the upper limit of normal separates the good-risk prognostic group into two distinct subgroups, with clearly inferior survival outcomes for the high-LDH subgroup. Validation of this prognostic factor has understandably opened the question of the optimal management for patients with high-LDH good-risk seminoma. In the absence of prospective evidence, guideline-recommended management options have not changed. However, there is evidence from the testicular cancer community that management trends might have been influenced by the poor prognosis associated with elevated LDH. The Testicular Cancer Guidelines Panel of the European Association of Urology has undertaken a global survey among oncologists and onco-urologists to document management trends and differences. PATIENT SUMMARY: Levels of an enzyme called LDH (lactate dehydrogenase) can differ among patients with testicular cancer that has good prognosis. Recent evidence shows worse outcomes for patients with higher LDH. This information should be used to update clinical guidelines and to tailor personalised treatment plans for these patients.
{"title":"Redefining Good-prognosis Seminoma: Implications for Clinical Practice of the Updated International Germ Cell Cancer Collaborative Group Classification and Results from the SEMITrends Survey.","authors":"Anna Patrikidou, Christoph Oing, Christos Markellos, Axel Heidenreich, Ricardo Leao, Nicola Nicolai, Joost Boormans, Stefanie Fischer, Christian Fankhauser, Walter Cazzaniga, Patrizia Giannatempo, Daniel Berney, Hendrik Gremmels, Robert Cornes, Florian Janisch, Domenico Di Nardo, Alexandros Papachristofilou, Karim Fizazi, Togrim Tandstad, David Nicol, Robert Huddart","doi":"10.1016/j.euo.2025.01.006","DOIUrl":"https://doi.org/10.1016/j.euo.2025.01.006","url":null,"abstract":"<p><p>The 2021 updated International Germ Cell Cancer Collaborative Group classification for seminomatous germ cell tumours confirmed and refined the original classification, introducing the notion that lactate dehydrogenase (LDH) elevation above 2.5 times the upper limit of normal separates the good-risk prognostic group into two distinct subgroups, with clearly inferior survival outcomes for the high-LDH subgroup. Validation of this prognostic factor has understandably opened the question of the optimal management for patients with high-LDH good-risk seminoma. In the absence of prospective evidence, guideline-recommended management options have not changed. However, there is evidence from the testicular cancer community that management trends might have been influenced by the poor prognosis associated with elevated LDH. The Testicular Cancer Guidelines Panel of the European Association of Urology has undertaken a global survey among oncologists and onco-urologists to document management trends and differences. PATIENT SUMMARY: Levels of an enzyme called LDH (lactate dehydrogenase) can differ among patients with testicular cancer that has good prognosis. Recent evidence shows worse outcomes for patients with higher LDH. This information should be used to update clinical guidelines and to tailor personalised treatment plans for these patients.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143363928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-03DOI: 10.1016/j.euo.2024.12.015
Cristian Udovicich, Patrick Cheung, William Chu, Hans Chung, Jay Detsky, Stanley Liu, Gerard Morton, Ewa Szumacher, Chia-Lin Tseng, Danny Vesprini, Wee Loon Ong, Thomas Kennedy, Melanie Davidson, Ananth Ravi, Merrylee McGuffin, Liying Zhang, Alexandre Mamedov, Andrea Deabreu, Meghan Kulasingham-Poon, Andrew Loblaw
Background and objective: Recent randomized controlled trials have demonstrated the efficacy of five-fraction stereotactic body radiotherapy (5F-SBRT) for prostate cancer (PC), but there is no comparative evidence for fewer fractions. We compare outcomes of prostate two-fraction SBRT (2F-SBRT) and 5F-SBRT using prospective data for patients with intermediate-risk (IR) PC.
Methods: This meta-analysis of individual patient data evaluated IR-PC from four prospective trials of prostate SBRT (two trials each of 2F- and 5F-SBRT). The primary endpoint was the cumulative incidence of biochemical failure (BCF). Secondary endpoints included the cumulative incidence of distant metastases (DM) and patient-reported quality of life (QoL).
Key findings and limitations: Of the 199 patients meeting the eligibility criteria, 143 (72%) were in the 5F-SBRT group and 56 (28%) were in the 2F-SBRT group. Median follow-up was 9.4 years. There was no significant difference in BCF with a 5-year cumulative incidence of 3.6% (95% CI 0-8.6%) in the 2F-SBRT group and 6.0% (95% CI 1.8-10.2%) in the 5F-SBRT group (p = 0.73). There was no significant difference in DM incidence. We found no differences in acute and late urinary or bowel QoL. Limitations include the non-randomized comparison.
Conclusions and clinical implications: We report the first prospective comparison of prostate 2F-SBRT and 5F-SBRT. We found no significant difference in efficacy, or in urinary or bowel QoL. This meta-analysis further encourages the potential of 2F-SBRT to be a standard-of-care option for IR PC.
{"title":"Two-fraction Versus Five-fraction Stereotactic Body Radiotherapy for Intermediate-risk Prostate Cancer: The TOFFEE Meta-analysis of Individual Patient Data from Four Prospective Trials.","authors":"Cristian Udovicich, Patrick Cheung, William Chu, Hans Chung, Jay Detsky, Stanley Liu, Gerard Morton, Ewa Szumacher, Chia-Lin Tseng, Danny Vesprini, Wee Loon Ong, Thomas Kennedy, Melanie Davidson, Ananth Ravi, Merrylee McGuffin, Liying Zhang, Alexandre Mamedov, Andrea Deabreu, Meghan Kulasingham-Poon, Andrew Loblaw","doi":"10.1016/j.euo.2024.12.015","DOIUrl":"https://doi.org/10.1016/j.euo.2024.12.015","url":null,"abstract":"<p><strong>Background and objective: </strong>Recent randomized controlled trials have demonstrated the efficacy of five-fraction stereotactic body radiotherapy (5F-SBRT) for prostate cancer (PC), but there is no comparative evidence for fewer fractions. We compare outcomes of prostate two-fraction SBRT (2F-SBRT) and 5F-SBRT using prospective data for patients with intermediate-risk (IR) PC.</p><p><strong>Methods: </strong>This meta-analysis of individual patient data evaluated IR-PC from four prospective trials of prostate SBRT (two trials each of 2F- and 5F-SBRT). The primary endpoint was the cumulative incidence of biochemical failure (BCF). Secondary endpoints included the cumulative incidence of distant metastases (DM) and patient-reported quality of life (QoL).</p><p><strong>Key findings and limitations: </strong>Of the 199 patients meeting the eligibility criteria, 143 (72%) were in the 5F-SBRT group and 56 (28%) were in the 2F-SBRT group. Median follow-up was 9.4 years. There was no significant difference in BCF with a 5-year cumulative incidence of 3.6% (95% CI 0-8.6%) in the 2F-SBRT group and 6.0% (95% CI 1.8-10.2%) in the 5F-SBRT group (p = 0.73). There was no significant difference in DM incidence. We found no differences in acute and late urinary or bowel QoL. Limitations include the non-randomized comparison.</p><p><strong>Conclusions and clinical implications: </strong>We report the first prospective comparison of prostate 2F-SBRT and 5F-SBRT. We found no significant difference in efficacy, or in urinary or bowel QoL. This meta-analysis further encourages the potential of 2F-SBRT to be a standard-of-care option for IR PC.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143187738","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-02DOI: 10.1016/j.euo.2025.01.011
Evelien J E van Altena, Bernard H E Jansen, André N Vis
{"title":"Reply to Ignacio Puche-Sanz, Ugo Giovanni Falagario, Giorgio Gandaglia, et al's Letter to the Editor re: Evelien J.E. van Altena, Bernard H.E. Jansen, Marieke L. Korbee, et al. Prostate-specific Membrane Antigen Positron Emission Tomography Before Reaching the Phoenix Criteria for Biochemical Recurrence of Prostate Cancer After Radiotherapy: Earlier Detection of Recurrences. Eur Urol Oncol. In press. https://doi.org/10.1016/j.euo.2024.09.015.","authors":"Evelien J E van Altena, Bernard H E Jansen, André N Vis","doi":"10.1016/j.euo.2025.01.011","DOIUrl":"https://doi.org/10.1016/j.euo.2025.01.011","url":null,"abstract":"","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2025-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143122543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.euo.2024.10.010
Karl H. Pang , Giuseppe Fallara , João Lobo , Hussain M. Alnajjar , Vijay Sangar , Conrad von Stempel , Dean Y. Huang , Arie Parnham , Walter Cazzaniga , Francesco Giganti , Aiman Haider , Ashwin Sachdeva , Maarten Albersen , Costi Alifrangis , Marco Bandini , Fabio Castiglione , Hielke-Martijn De Vries , Christian Fankhauser , Daniel Heffernan Ho , David Nicol , Asif Muneer
Background and objective
The majority of small testicular masses (STMs) are benign and therefore radical orchidectomy (RO) may represent overtreatment. In appropriately selected patients, surveillance or testis-sparing surgery (TSS) is an alternative option to preserve testicular function. Since there are no clear guidelines, we aimed to develop consensus recommendations on the management of STMs.
Methods
A four-round Delphi study was conducted by 24 experts representing multiple subspecialties to reach consensus. Consensus was defined as ≥75% of the participants scoring within the same 3-point grouping (1–3, disagree; 4–6, uncertain; 7–9, agree.). The first two rounds were survey based, the third round was an online meeting to discuss uncertainties from the first two rounds, and the fourth round was a review of the final consensus statements from rounds 1–3.
Key findings and limitations
The initial survey consisted of 126 statements. Following the four rounds of assessment, a list of 96 statements were produced, which focused on clinical and biochemical assessment, colour Doppler ultrasound (CDUS) characteristics, and management options including surveillance, RO, and TSS. Management should be personalised according to risk factors for testicular cancer, fertility status, uni- or bilateral tumours, status of the contralateral testis, and CDUS characteristics, with solid lesions displaying vascularity and hypoechogenicity being more suspicious for malignancy. The consensus statements are prone to a bias, and some may not reflect robust, randomised evidence.
Conclusions and clinical implications
The expert panel has produced consensus recommendations on the management of STMs, and TSS should be considered in patients with an STM. The recommendations could aid in the dissemination of best practice.
Patient summary
There are no clear guidelines on the management of small testicular masses. Excising the whole testicle (radical orchidectomy) with a small or an indeterminate mass may affect fertility and hormonal function. A panel of experts was formed, and consensus recommendations were developed on how to deal with small and indeterminate testicular masses, which include surveillance or testis-sparing surgery.
{"title":"Management of Small Testicular Masses: A Delphi Consensus Study","authors":"Karl H. Pang , Giuseppe Fallara , João Lobo , Hussain M. Alnajjar , Vijay Sangar , Conrad von Stempel , Dean Y. Huang , Arie Parnham , Walter Cazzaniga , Francesco Giganti , Aiman Haider , Ashwin Sachdeva , Maarten Albersen , Costi Alifrangis , Marco Bandini , Fabio Castiglione , Hielke-Martijn De Vries , Christian Fankhauser , Daniel Heffernan Ho , David Nicol , Asif Muneer","doi":"10.1016/j.euo.2024.10.010","DOIUrl":"10.1016/j.euo.2024.10.010","url":null,"abstract":"<div><h3>Background and objective</h3><div>The majority of small testicular masses (STMs) are benign and therefore radical orchidectomy (RO) may represent overtreatment. In appropriately selected patients, surveillance or testis-sparing surgery (TSS) is an alternative option to preserve testicular function. Since there are no clear guidelines, we aimed to develop consensus recommendations on the management of STMs.</div></div><div><h3>Methods</h3><div>A four-round Delphi study was conducted by 24 experts representing multiple subspecialties to reach consensus. Consensus was defined as ≥75% of the participants scoring within the same 3-point grouping (1–3, disagree; 4–6, uncertain; 7–9, agree.). The first two rounds were survey based, the third round was an online meeting to discuss uncertainties from the first two rounds, and the fourth round was a review of the final consensus statements from rounds 1–3.</div></div><div><h3>Key findings and limitations</h3><div>The initial survey consisted of 126 statements. Following the four rounds of assessment, a list of 96 statements were produced, which focused on clinical and biochemical assessment, colour Doppler ultrasound (CDUS) characteristics, and management options including surveillance, RO, and TSS. Management should be personalised according to risk factors for testicular cancer, fertility status, uni- or bilateral tumours, status of the contralateral testis, and CDUS characteristics, with solid lesions displaying vascularity and hypoechogenicity being more suspicious for malignancy. The consensus statements are prone to a bias, and some may not reflect robust, randomised evidence.</div></div><div><h3>Conclusions and clinical implications</h3><div>The expert panel has produced consensus recommendations on the management of STMs, and TSS should be considered in patients with an STM. The recommendations could aid in the dissemination of best practice.</div></div><div><h3>Patient summary</h3><div>There are no clear guidelines on the management of small testicular masses. Excising the whole testicle (radical orchidectomy) with a small or an indeterminate mass may affect fertility and hormonal function. A panel of experts was formed, and consensus recommendations were developed on how to deal with small and indeterminate testicular masses, which include surveillance or testis-sparing surgery.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 1","pages":"Pages 152-163"},"PeriodicalIF":8.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142581887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.euo.2024.09.007
Franziska Gross , Ida Marie Lind Rasmussen , Elisabeth Grov Beisland , Gøril Tvedten Jorem , Christian Beisland , Helle Pappot , Juan Ignacio Arraras , Madeline Pe , Bernhard Holzner , Lisa M. Wintner , EORTC Quality of Life Group
<div><h3>Background and objective</h3><div>In oncology, patient-reported outcome measures (PROMs) capturing health-related quality of life (HRQOL) play an increasing role in clinical trials, drug approval, and policy making. This scoping review aimed to identify and elaborate on HRQOL-focussed PROMs used in renal cell cancer (RCC) clinical trials.</div></div><div><h3>Methods</h3><div>MEDLINE, Web of Science, PsychINFO, Academic Search Elite, CINAHL, Embase, and the Cochrane Library were searched systematically for original peer-reviewed articles on clinical trials including RCC patients and using PROMs, published between 1950 and 2023. Prespecified trial characteristics and information on the PROMs used were extracted. Frequencies and proportions of categorical data, and ranges and medians of continuous variables were calculated.</div></div><div><h3>Key findings and limitations</h3><div>Of the 48 unique studies included, the majority followed a randomised controlled design (34, 71%) and evaluated systemic treatments (38, 79%). The trials used 27 different PROMs (max = 6, median = 2), of which only 4 (15%) were developed specifically for kidney cancer patients. Of the trials, 46% did not use any RCC-specific PROM. European Quality of Life—5 Dimensions (EQ-5D), European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI) —15/19-item version, FKSI—Disease Related Symptoms, and Functional Assessment of Cancer Therapy—General (FACT-G) were the most frequently used questionnaires, with pain, ability to work, fatigue, worry, and sleep quality being the most commonly assessed issues.</div></div><div><h3>Conclusions and clinical implications</h3><div>A variety of PROMs are used in RCC patients, hindering interpretability across trials. The PROMs used differ in terms of both the domains assessed and how the issues are translated into questionnaire items. Though RCC-specific PROMs exist, these have flaws in terms of relevance to patients. To answer predefined relevant HRQOL research questions, revised RCC-specific PROMs and standardisation of their integration into clinical trials are warranted.</div></div><div><h3>Patient summary</h3><div>Researchers are more and more interested in the health-related quality of life of kidney cancer patients and use questionnaires to measure it. This review shows that there are many different health-related quality of life questionnaires that are used in different combinations in clinical trials for kidney cancer patients. This makes it very difficult to compare these study results and draw reliable conclusions for the actual clinical treatment. It was even found that some of the questionnaires used do not capture things that patients actually consider important (eg, emotional issues such as dealing with thoughts about cancer and depression). Therefore, more work needs to be done to develop questionnaires t
{"title":"Health-related Quality of Life Assessment in Renal Cell Cancer: A Scoping Review","authors":"Franziska Gross , Ida Marie Lind Rasmussen , Elisabeth Grov Beisland , Gøril Tvedten Jorem , Christian Beisland , Helle Pappot , Juan Ignacio Arraras , Madeline Pe , Bernhard Holzner , Lisa M. Wintner , EORTC Quality of Life Group","doi":"10.1016/j.euo.2024.09.007","DOIUrl":"10.1016/j.euo.2024.09.007","url":null,"abstract":"<div><h3>Background and objective</h3><div>In oncology, patient-reported outcome measures (PROMs) capturing health-related quality of life (HRQOL) play an increasing role in clinical trials, drug approval, and policy making. This scoping review aimed to identify and elaborate on HRQOL-focussed PROMs used in renal cell cancer (RCC) clinical trials.</div></div><div><h3>Methods</h3><div>MEDLINE, Web of Science, PsychINFO, Academic Search Elite, CINAHL, Embase, and the Cochrane Library were searched systematically for original peer-reviewed articles on clinical trials including RCC patients and using PROMs, published between 1950 and 2023. Prespecified trial characteristics and information on the PROMs used were extracted. Frequencies and proportions of categorical data, and ranges and medians of continuous variables were calculated.</div></div><div><h3>Key findings and limitations</h3><div>Of the 48 unique studies included, the majority followed a randomised controlled design (34, 71%) and evaluated systemic treatments (38, 79%). The trials used 27 different PROMs (max = 6, median = 2), of which only 4 (15%) were developed specifically for kidney cancer patients. Of the trials, 46% did not use any RCC-specific PROM. European Quality of Life—5 Dimensions (EQ-5D), European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI) —15/19-item version, FKSI—Disease Related Symptoms, and Functional Assessment of Cancer Therapy—General (FACT-G) were the most frequently used questionnaires, with pain, ability to work, fatigue, worry, and sleep quality being the most commonly assessed issues.</div></div><div><h3>Conclusions and clinical implications</h3><div>A variety of PROMs are used in RCC patients, hindering interpretability across trials. The PROMs used differ in terms of both the domains assessed and how the issues are translated into questionnaire items. Though RCC-specific PROMs exist, these have flaws in terms of relevance to patients. To answer predefined relevant HRQOL research questions, revised RCC-specific PROMs and standardisation of their integration into clinical trials are warranted.</div></div><div><h3>Patient summary</h3><div>Researchers are more and more interested in the health-related quality of life of kidney cancer patients and use questionnaires to measure it. This review shows that there are many different health-related quality of life questionnaires that are used in different combinations in clinical trials for kidney cancer patients. This makes it very difficult to compare these study results and draw reliable conclusions for the actual clinical treatment. It was even found that some of the questionnaires used do not capture things that patients actually consider important (eg, emotional issues such as dealing with thoughts about cancer and depression). Therefore, more work needs to be done to develop questionnaires t","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 1","pages":"Pages 201-212"},"PeriodicalIF":8.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142375367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The relevance of next-generation hormone therapies and circulating tumor cells (CTCs) are not elucidated in biochemical recurrence after prostatectomy.
Objective
To evaluate the combination of abiraterone acetate plus prednisone (AAP), prostate bed radiotherapy (PBRT), and goserelin in biochemically relapsing men after prostatectomy, and to investigate the utility of CTCs.
Design, setting, and participants
In this single-arm multicenter phase 2 trial, 46 biochemically relapsing men were enrolled between December 2012 and January 2019. The median follow-up was 47 mo.
Intervention
All patients received AAP 1000 mg daily (but 750 mg during PBRT), salvage PBRT, and goserelin.
Outcome measurements and statistical analysis
The primary outcome was 3-yr biochemical recurrence-free survival (bRFS) when prostate-specific antigen (PSA) levels were ≥0.2 ng/ml. The secondary outcomes included alternative bRFS (alt-bRFS) when PSA levels were ≥0.5 ng/ml and safety assessment. CTC count was assessed.
Results and limitations
The 3-yr bRFS and alt-bRFS were 81.5% (95% confidence interval or CI [66.4–90.3%]) and 95.6% (95% CI [83.5-98.9%]), respectively. The most common acute radiotherapy-related adverse effect (AE; all grades was pollakiuria (41.3%). The most common late AE (all grades) was urinary incontinence (15.2%). Grade 3-4 acute or late radiotherapy-related AEs were scarce. Most frequent AEs nonrelated to radiotherapy were hot flashes (76%), hypertension (63%), and hepatic cytolysis (50%, of which 20% were of grades 3-4). Of the patients, 11% had a CTC count of ≥5, which was correlated with poorer bRFS (p = 0.042) and alt-bRFS (p = 0.008). The association between CTC count and higher rates of relapse was independent of the baseline PSA level and PSA doubling time (p = 0.42 and p = 0.09, respectively). This study was nonrandomized with a limited number of patients, and few clinical events were reported.
Conclusions
Adding AAP to salvage radiation therapy and goserelin resulted in high bRFS and alt-bRFS. AEs remained manageable, although a close liver surveillance is advised. CTC count appears as a promising biomarker for prognosis and predicting response to treatment.
Patient summary
Our study was a phase 2 clinical trial that exhibited the efficacy and tolerance of a novel androgen-receptor targeting agent (abiraterone acetate plus prednisone) in patients with prostate cancer who experienced rising prostate-specific antigen after radical prostatectomy, in combination with prostate bed radiotherapy. The results also indicated the feasibility and potential value of circulating tumor cell detection, which constitutes a possible advance in managing prostate cancers.
{"title":"Combination of Abiraterone Acetate, Prostate Bed Radiotherapy, and Luteinizing Hormone-releasing Hormone Agonists in Biochemically Relapsing Patients After Prostatectomy (CARLHA): A Phase 2 Clinical Trial","authors":"Loic Ah-Thiane , Loic Campion , Nedjla Allouache , Emmanuel Meyer , Pascal Pommier , Nathalie Mesgouez-Nebout , Anne-Agathe Serre , Gilles Créhange , Valentine Guimas , Emmanuel Rio , Paul Sargos , Sylvain Ladoire , Céline Mahier Ait Oukhatar , Stéphane Supiot","doi":"10.1016/j.euo.2024.04.014","DOIUrl":"10.1016/j.euo.2024.04.014","url":null,"abstract":"<div><h3>Background</h3><div>The relevance of next-generation hormone therapies and circulating tumor cells (CTCs) are not elucidated in biochemical recurrence after prostatectomy.</div></div><div><h3>Objective</h3><div>To evaluate the combination of abiraterone acetate plus prednisone (AAP), prostate bed radiotherapy (PBRT), and goserelin in biochemically relapsing men after prostatectomy, and to investigate the utility of CTCs.</div></div><div><h3>Design, setting, and participants</h3><div>In this single-arm multicenter phase 2 trial, 46 biochemically relapsing men were enrolled between December 2012 and January 2019. The median follow-up was 47 mo.</div></div><div><h3>Intervention</h3><div>All patients received AAP 1000 mg daily (but 750 mg during PBRT), salvage PBRT, and goserelin.</div></div><div><h3>Outcome measurements and statistical analysis</h3><div>The primary outcome was 3-yr biochemical recurrence-free survival (bRFS) when prostate-specific antigen (PSA) levels were ≥0.2 ng/ml. The secondary outcomes included alternative bRFS (alt-bRFS) when PSA levels were ≥0.5 ng/ml and safety assessment. CTC count was assessed.</div></div><div><h3>Results and limitations</h3><div>The 3-yr bRFS and alt-bRFS were 81.5% (95% confidence interval or CI [66.4–90.3%]) and 95.6% (95% CI [83.5-98.9%]), respectively. The most common acute radiotherapy-related adverse effect (AE; all grades was pollakiuria (41.3%). The most common late AE (all grades) was urinary incontinence (15.2%). Grade 3-4 acute or late radiotherapy-related AEs were scarce. Most frequent AEs nonrelated to radiotherapy were hot flashes (76%), hypertension (63%), and hepatic cytolysis (50%, of which 20% were of grades 3-4). Of the patients, 11% had a CTC count of ≥5, which was correlated with poorer bRFS (<em>p</em> = 0.042) and alt-bRFS (<em>p</em> = 0.008). The association between CTC count and higher rates of relapse was independent of the baseline PSA level and PSA doubling time (<em>p</em> = 0.42 and <em>p</em> = 0.09, respectively). This study was nonrandomized with a limited number of patients, and few clinical events were reported.</div></div><div><h3>Conclusions</h3><div>Adding AAP to salvage radiation therapy and goserelin resulted in high bRFS and alt-bRFS. AEs remained manageable, although a close liver surveillance is advised. CTC count appears as a promising biomarker for prognosis and predicting response to treatment.</div></div><div><h3>Patient summary</h3><div>Our study was a phase 2 clinical trial that exhibited the efficacy and tolerance of a novel androgen-receptor targeting agent (abiraterone acetate plus prednisone) in patients with prostate cancer who experienced rising prostate-specific antigen after radical prostatectomy, in combination with prostate bed radiotherapy. The results also indicated the feasibility and potential value of circulating tumor cell detection, which constitutes a possible advance in managing prostate cancers.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 1","pages":"Pages 38-46"},"PeriodicalIF":8.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140907917","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.euo.2024.05.004
Xiaoyang Du , Shuang Hao , Henrik Olsson , Kimmo Kartasalo , Nita Mulliqi , Balram Rai , Dominik Menges , Emelie Heintz , Lars Egevad , Martin Eklund , Mark Clements
Background and objective
Image-based artificial intelligence (AI) methods have shown high accuracy in prostate cancer (PCa) detection. Their impact on patient outcomes and cost effectiveness in comparison to human pathologists remains unknown. Our aim was to evaluate the effectiveness and cost-effectiveness of AI-assisted pathology for PCa diagnosis in Sweden.
Methods
We modeled quadrennial prostate-specific antigen (PSA) screening for men between the ages of 50 and 74 yr over a lifetime horizon using a health care perspective. Men with PSA ≥3 ng/ml were referred for standard biopsy (SBx), for which cores were either examined via AI followed by a pathologist for AI-labeled positive cores, or a pathologist alone. The AI performance characteristics were estimated using an internal STHLM3 validation data set. Outcome measures included the number of tests, PCa incidence and mortality, overdiagnosis, quality-adjusted life years (QALYs), and the potential reduction in pathologist-evaluated biopsy cores if AI were used. Cost-effectiveness was assessed using the incremental cost-effectiveness ratio.
Key findings and limitations
In comparison to a pathologist alone, the AI-assisted workflow increased the number of PSA tests, SBx procedures, and PCa deaths by ≤0.03%, and slightly reduced PCa incidence and overdiagnosis. AI would reduce the proportion of biopsy cores evaluated by a pathologist by 80%. At a cost of €10 per case, the AI-assisted workflow would cost less and result in <0.001% lower QALYs in comparison to a pathologist alone. The results were sensitive to the AI cost.
Conclusions and clinical implications
According to our model, AI-assisted pathology would significantly decrease the workload of pathologists, would not affect patient quality of life, and would yield cost savings in Sweden when compared to a human pathologist alone.
Patient summary
We compared outcomes for prostate cancer patients and relevant costs for two methods of assessing prostate biopsies in Sweden: (1) artificial intelligence (AI) technology and review of positive biopsies by a human pathologist; and (2) a human pathologist alone for all biopsies. We found that addition of AI would reduce the pathology workload and save money, and would not affect patient outcomes when compared to a human pathologist alone. The results suggest that adding AI to prostate pathology in Sweden would save costs.
{"title":"Effectiveness and Cost-effectiveness of Artificial Intelligence–assisted Pathology for Prostate Cancer Diagnosis in Sweden: A Microsimulation Study","authors":"Xiaoyang Du , Shuang Hao , Henrik Olsson , Kimmo Kartasalo , Nita Mulliqi , Balram Rai , Dominik Menges , Emelie Heintz , Lars Egevad , Martin Eklund , Mark Clements","doi":"10.1016/j.euo.2024.05.004","DOIUrl":"10.1016/j.euo.2024.05.004","url":null,"abstract":"<div><h3>Background and objective</h3><div>Image-based artificial intelligence (AI) methods have shown high accuracy in prostate cancer (PCa) detection. Their impact on patient outcomes and cost effectiveness in comparison to human pathologists remains unknown. Our aim was to evaluate the effectiveness and cost-effectiveness of AI-assisted pathology for PCa diagnosis in Sweden.</div></div><div><h3>Methods</h3><div>We modeled quadrennial prostate-specific antigen (PSA) screening for men between the ages of 50 and 74 yr over a lifetime horizon using a health care perspective. Men with PSA ≥3 ng/ml were referred for standard biopsy (SBx), for which cores were either examined via AI followed by a pathologist for AI-labeled positive cores, or a pathologist alone. The AI performance characteristics were estimated using an internal STHLM3 validation data set. Outcome measures included the number of tests, PCa incidence and mortality, overdiagnosis, quality-adjusted life years (QALYs), and the potential reduction in pathologist-evaluated biopsy cores if AI were used. Cost-effectiveness was assessed using the incremental cost-effectiveness ratio.</div></div><div><h3>Key findings and limitations</h3><div>In comparison to a pathologist alone, the AI-assisted workflow increased the number of PSA tests, SBx procedures, and PCa deaths by ≤0.03%, and slightly reduced PCa incidence and overdiagnosis. AI would reduce the proportion of biopsy cores evaluated by a pathologist by 80%. At a cost of €10 per case, the AI-assisted workflow would cost less and result in <0.001% lower QALYs in comparison to a pathologist alone. The results were sensitive to the AI cost.</div></div><div><h3>Conclusions and clinical implications</h3><div>According to our model, AI-assisted pathology would significantly decrease the workload of pathologists, would not affect patient quality of life, and would yield cost savings in Sweden when compared to a human pathologist alone.</div></div><div><h3>Patient summary</h3><div>We compared outcomes for prostate cancer patients and relevant costs for two methods of assessing prostate biopsies in Sweden: (1) artificial intelligence (AI) technology and review of positive biopsies by a human pathologist; and (2) a human pathologist alone for all biopsies. We found that addition of AI would reduce the pathology workload and save money, and would not affect patient outcomes when compared to a human pathologist alone. The results suggest that adding AI to prostate pathology in Sweden would save costs.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 1","pages":"Pages 80-86"},"PeriodicalIF":8.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141093309","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.euo.2024.08.009
Julien Anract , Clément Klein , Ugo Pinar , Morgan Rouprêt , Nicolas Barry Delongchamps , Grégoire Robert
Background and objective
Histopathological examination of surgical specimens for benign prostatic hyperplasia (BPH) can detect incidental prostate cancer (iPCa). The aim of our study was to develop a predictive model for iPCa diagnosis for patients for whom BPH surgery is being considered.
Methods
We conducted a retrospective analysis of medical files for patients who underwent BPH surgery in three academic centers between 2012 and 2022. Patients diagnosed with PCa before surgery were excluded. We calculated the global iPCa rate, and the clinically significant iPCa rate (grade group ≥2). Univariate and multivariable regression models were used to assess factors predictive of iPCa. The area under the receiver operating characteristic curve (AUC) was compared for each risk factor and for the global model. We used χ2 automated interaction detection (CHAID) for decision tree analysis.
Key findings and limitations
We included 2452 patients in the analysis, of whom 247 (10.0%) had iPCa, which was clinically significant in 49/247 cases (20.2%). Multivariable analysis revealed that age and prostate-specific antigen density (PSAD) were independent predictive factors for iPCa diagnosis. The AUC for a model including age and PSAD was 0.65. CHAID analysis revealed that patients with PSAD >0.1 ng/ml/cm3 had an iPCa risk of 23.4% (χ2 = 52.6; p < 0.001). For those patients, age >72 yr increased the iPCa risk to 35.4% (χ2 = 11.1, p = 0.008). Our study is mainly limited by its retrospective design.
Conclusions and clinical implications
Age and PSAD were independent risk factors for iPCa diagnosis. The combination of age >72 yr and PSAD >0.1 ng/ml/cm3 was associated with an iPCa rate of 35.4%.
Patient summary
We performed a study to find predictors of prostate cancer for patients undergoing surgery for benign enlargement of the prostate. Our model can identify patients at risk, and diagnose their cancer before surgery. This could avoid unnecessary or harmful procedures.
{"title":"Incidental Prostate Cancer in Patients Undergoing Surgery for Benign Prostatic Hyperplasia: A Predictive Model","authors":"Julien Anract , Clément Klein , Ugo Pinar , Morgan Rouprêt , Nicolas Barry Delongchamps , Grégoire Robert","doi":"10.1016/j.euo.2024.08.009","DOIUrl":"10.1016/j.euo.2024.08.009","url":null,"abstract":"<div><h3>Background and objective</h3><div>Histopathological examination of surgical specimens for benign prostatic hyperplasia (BPH) can detect incidental prostate cancer (iPCa). The aim of our study was to develop a predictive model for iPCa diagnosis for patients for whom BPH surgery is being considered.</div></div><div><h3>Methods</h3><div>We conducted a retrospective analysis of medical files for patients who underwent BPH surgery in three academic centers between 2012 and 2022. Patients diagnosed with PCa before surgery were excluded. We calculated the global iPCa rate, and the clinically significant iPCa rate (grade group ≥2). Univariate and multivariable regression models were used to assess factors predictive of iPCa. The area under the receiver operating characteristic curve (AUC) was compared for each risk factor and for the global model. We used χ<sup>2</sup> automated interaction detection (CHAID) for decision tree analysis.</div></div><div><h3>Key findings and limitations</h3><div>We included 2452 patients in the analysis, of whom 247 (10.0%) had iPCa, which was clinically significant in 49/247 cases (20.2%). Multivariable analysis revealed that age and prostate-specific antigen density (PSAD) were independent predictive factors for iPCa diagnosis. The AUC for a model including age and PSAD was 0.65. CHAID analysis revealed that patients with PSAD >0.1 ng/ml/cm<sup>3</sup> had an iPCa risk of 23.4% (χ<sup>2</sup> = 52.6; <em>p</em> < 0.001). For those patients, age >72 yr increased the iPCa risk to 35.4% (χ<sup>2</sup> = 11.1, <em>p</em> = 0.008). Our study is mainly limited by its retrospective design.</div></div><div><h3>Conclusions and clinical implications</h3><div>Age and PSAD were independent risk factors for iPCa diagnosis. The combination of age >72 yr and PSAD >0.1 ng/ml/cm<sup>3</sup> was associated with an iPCa rate of 35.4%.</div></div><div><h3>Patient summary</h3><div>We performed a study to find predictors of prostate cancer for patients undergoing surgery for benign enlargement of the prostate. Our model can identify patients at risk, and diagnose their cancer before surgery. This could avoid unnecessary or harmful procedures.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 1","pages":"Pages 145-151"},"PeriodicalIF":8.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.euo.2024.12.004
Olivier Cussenot , Morgan Rouprêt , Shahrokh F. Shariat
{"title":"Time to Refine Prostate Cancer Epidemiology: Defining New Endpoints for Effective Screening and Causal Epidemiological Studies","authors":"Olivier Cussenot , Morgan Rouprêt , Shahrokh F. Shariat","doi":"10.1016/j.euo.2024.12.004","DOIUrl":"10.1016/j.euo.2024.12.004","url":null,"abstract":"","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 1","pages":"Pages 7-8"},"PeriodicalIF":8.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142893087","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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