Thomas Paul Scherer, Anna Gugerli Lazos, Julian Sonderer, Basil Kaufmann, Florian Alexander Schmid, Josef Jenewein, Niels J Rupp, Holger Moch, Daniel Eberli, Ashkan Mortezavi
{"title":"接受局灶治疗的前列腺癌患者的焦虑和健康相关生活质量：一项前瞻性单臂2期试验","authors":"Thomas Paul Scherer, Anna Gugerli Lazos, Julian Sonderer, Basil Kaufmann, Florian Alexander Schmid, Josef Jenewein, Niels J Rupp, Holger Moch, Daniel Eberli, Ashkan Mortezavi","doi":"10.1016/j.euf.2025.08.006","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and objective: </strong>While whole-gland therapies for localized prostate cancer (PCa) offer excellent oncological outcomes, these can impact patients' quality of life (QoL) through serious side effects. Focal therapy using high-intensity focused ultrasound (HIFU) has emerged as a less invasive alternative to preserve QoL. However, data on the psychological impact of HIFU remain rare. This prospective study evaluates health-related QoL and emotional burden over 36 mo in men undergoing focal HIFU.</p><p><strong>Methods: </strong>In this prospective, single-arm, phase 2 trial (NCT02265159), 91 men with localized PCa (International Society of Urological Pathology grade group ≤3 and prostate-specific antigen ≤15 ng/ml) were treated with focal HIFU. Psychological distress and QoL were assessed at baseline and 6, 12, and 36 mo after HIFU using the following questionnaires: Memorial Anxiety Scale for Prostate Cancer (MAX-PC; PCa-specific anxiety), Hospital Anxiety and Depression Scale (HADS; anxiety and depression), and Functional Assessment of Cancer Therapy-Prostate (FACT-P; health-related QoL). Clinically significant distress was determined using established cutoffs.</p><p><strong>Key findings and limitations: </strong>The psychological burden was generally low throughout the study period. MAX-PC scores declined steadily over time. HADS anxiety and depression scores displayed a transient increase at 6 and 12 mo, but returned to baseline at 36 mo. At all time points, <3% of patients had scores above the threshold for clinically significant distress on the MAX-PC and HADS questionnaires. FACT-P scores remained stable and high, with no significant score changes in the total health-related QoL.</p><p><strong>Conclusions and clinical implications: </strong>Focal HIFU treatment for localized PCa is associated with a low psychological burden and stable, high health-related QoL. These results demonstrate the enduring impact of this organ-sparing approach on both psychological and QoL outcomes.</p>","PeriodicalId":12160,"journal":{"name":"European urology focus","volume":" ","pages":""},"PeriodicalIF":5.6000,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Anxiety and Health-related Quality of Life in Men with Prostate Cancer Undergoing Focal Therapy: A Prospective Single-arm Phase 2 Trial.\",\"authors\":\"Thomas Paul Scherer, Anna Gugerli Lazos, Julian Sonderer, Basil Kaufmann, Florian Alexander Schmid, Josef Jenewein, Niels J Rupp, Holger Moch, Daniel Eberli, Ashkan Mortezavi\",\"doi\":\"10.1016/j.euf.2025.08.006\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and objective: </strong>While whole-gland therapies for localized prostate cancer (PCa) offer excellent oncological outcomes, these can impact patients' quality of life (QoL) through serious side effects. Focal therapy using high-intensity focused ultrasound (HIFU) has emerged as a less invasive alternative to preserve QoL. However, data on the psychological impact of HIFU remain rare. This prospective study evaluates health-related QoL and emotional burden over 36 mo in men undergoing focal HIFU.</p><p><strong>Methods: </strong>In this prospective, single-arm, phase 2 trial (NCT02265159), 91 men with localized PCa (International Society of Urological Pathology grade group ≤3 and prostate-specific antigen ≤15 ng/ml) were treated with focal HIFU. Psychological distress and QoL were assessed at baseline and 6, 12, and 36 mo after HIFU using the following questionnaires: Memorial Anxiety Scale for Prostate Cancer (MAX-PC; PCa-specific anxiety), Hospital Anxiety and Depression Scale (HADS; anxiety and depression), and Functional Assessment of Cancer Therapy-Prostate (FACT-P; health-related QoL). Clinically significant distress was determined using established cutoffs.</p><p><strong>Key findings and limitations: </strong>The psychological burden was generally low throughout the study period. MAX-PC scores declined steadily over time. HADS anxiety and depression scores displayed a transient increase at 6 and 12 mo, but returned to baseline at 36 mo. At all time points, <3% of patients had scores above the threshold for clinically significant distress on the MAX-PC and HADS questionnaires. FACT-P scores remained stable and high, with no significant score changes in the total health-related QoL.</p><p><strong>Conclusions and clinical implications: </strong>Focal HIFU treatment for localized PCa is associated with a low psychological burden and stable, high health-related QoL. 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Anxiety and Health-related Quality of Life in Men with Prostate Cancer Undergoing Focal Therapy: A Prospective Single-arm Phase 2 Trial.
Background and objective: While whole-gland therapies for localized prostate cancer (PCa) offer excellent oncological outcomes, these can impact patients' quality of life (QoL) through serious side effects. Focal therapy using high-intensity focused ultrasound (HIFU) has emerged as a less invasive alternative to preserve QoL. However, data on the psychological impact of HIFU remain rare. This prospective study evaluates health-related QoL and emotional burden over 36 mo in men undergoing focal HIFU.
Methods: In this prospective, single-arm, phase 2 trial (NCT02265159), 91 men with localized PCa (International Society of Urological Pathology grade group ≤3 and prostate-specific antigen ≤15 ng/ml) were treated with focal HIFU. Psychological distress and QoL were assessed at baseline and 6, 12, and 36 mo after HIFU using the following questionnaires: Memorial Anxiety Scale for Prostate Cancer (MAX-PC; PCa-specific anxiety), Hospital Anxiety and Depression Scale (HADS; anxiety and depression), and Functional Assessment of Cancer Therapy-Prostate (FACT-P; health-related QoL). Clinically significant distress was determined using established cutoffs.
Key findings and limitations: The psychological burden was generally low throughout the study period. MAX-PC scores declined steadily over time. HADS anxiety and depression scores displayed a transient increase at 6 and 12 mo, but returned to baseline at 36 mo. At all time points, <3% of patients had scores above the threshold for clinically significant distress on the MAX-PC and HADS questionnaires. FACT-P scores remained stable and high, with no significant score changes in the total health-related QoL.
Conclusions and clinical implications: Focal HIFU treatment for localized PCa is associated with a low psychological burden and stable, high health-related QoL. These results demonstrate the enduring impact of this organ-sparing approach on both psychological and QoL outcomes.
期刊介绍：
European Urology Focus is a new sister journal to European Urology and an official publication of the European Association of Urology (EAU).
EU Focus will publish original articles, opinion piece editorials and topical reviews on a wide range of urological issues such as oncology, functional urology, reconstructive urology, laparoscopy, robotic surgery, endourology, female urology, andrology, paediatric urology and sexual medicine. The editorial team welcome basic and translational research articles in the field of urological diseases. Authors may be solicited by the Editor directly. All submitted manuscripts will be peer-reviewed by a panel of experts before being considered for publication.
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