{"id":351,"date":"2025-09-12T14:09:54","date_gmt":"2025-09-12T12:09:54","guid":{"rendered":"https:\/\/bcamonitor.org\/?p=351"},"modified":"2026-09-22T13:05:54","modified_gmt":"2026-09-22T13:05:54","slug":"towards-new-clinical-practice-in-nmibc-monitoring","status":"publish","type":"post","link":"https:\/\/bcamonitor.org\/?p=351","title":{"rendered":"Towards new clinical practice in NMIBC monitoring?"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.16&#8243; min_height=&#8221;392px&#8221; custom_margin=&#8221;||2px|||&#8221; custom_padding=&#8221;0px||0px|||&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_row _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;||8px||false|false&#8221; custom_padding=&#8221;||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_text _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;]<\/p>\n<h1>The DaBlaCa-15 trial paves the way for urinary biomarker integration<\/h1>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;4.16&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; min_height=&#8221;372px&#8221; custom_margin=&#8221;0px||||false|false&#8221; custom_padding=&#8221;0px||8px||false|false&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_text admin_label=&#8221;Text&#8221; _builder_version=&#8221;4.16&#8243; header_text_color=&#8221;#3b8dbf&#8221; header_6_font=&#8221;|300|||||||&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; min_height=&#8221;382.6px&#8221; custom_margin=&#8221;0px||||false|false&#8221; custom_padding=&#8221;0px||||false|false&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;]<\/p>\n<p><em>Reviewed by Joost Boormans<\/em><\/p>\n<p>&nbsp;<\/p>\n<p><span>Non-muscle-invasive bladder cancer (NMIBC) demands diligent and often lifelong surveillance, primarily through frequent cystoscopies. While crucial for detecting recurrences, this intensive follow-up is invasive, can cause discomfort and anxiety for patients, and contributes significantly to healthcare costs. In addition, the use of labour and outpatient capacity, as well as the ecological footprint of lifelong surveillance are not to be neglected. The DaBlaCa-15 trial, a randomised controlled study, sought to challenge this paradigm by investigating a less invasive, yet equally effective approach with a urinary biomarker in the follow-up of NMIBC.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-size: medium\"><strong><span style=\"font-family: inherit\">DaBlaCa-15 trial: Unpacking the key findings\u00a0<\/span><\/strong><\/span><\/p>\n<p><span>The DaBlaCa-15 trial, conducted across 4 urological centres in Denmark, randomised 392 patients with high-grade NMIBC [1]. The study was a non-inferiority trial of standard-of-care follow-up versus alternating the Xpert\u00ae Bladder Cancer Monitor (XBCM) urinary biomarker with cystoscopy could safely reduce the frequency of cystoscopies, while not jeopardizing oncological outcome in terms of high-grade recurrence-free survival. <\/span><\/p>\n<p>&nbsp;<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/bcamonitor.org\/wp-content\/uploads\/2025\/09\/Picture1.png\" width=\"838\" height=\"230\" alt=\"\" class=\"wp-image-31597 alignnone size-full\" \/><\/p>\n<p>&nbsp;<\/p>\n<p><span>The trial&#8217;s primary outcome was the 2-year high-grade recurrence-free survival between the 2 study arms. The results were highly encouraging:<\/span><\/p>\n<ul>\n<li><strong>Non-inferior detection<\/strong>: At 2 years, out of 43 total high-grade recurrences, 22 (11.6%) occurred in the intervention arm and 21 (11.2%) in the control arm, with a minimal risk difference of 0.08%<\/li>\n<li><strong>Significant reduction in cystoscopies<\/strong>: patients in the intervention arm underwent only 445 cystoscopies in total, a <strong>55% reduction<\/strong> compared to 1,029 cystoscopies in the control arm<\/li>\n<li><strong>No increased progression risk<\/strong> in the intervention arm<\/li>\n<li><strong>Anticipatory positive effect:<\/strong> in 13 out of 22 high-grade recurrences in the intervention arm, the XBCM test was positive with a median lead time of 8.3 months <strong>before the recurrence was visible on cystoscopy<\/strong>. This suggests the test can detect molecular changes preceding visually apparent tumours<\/li>\n<li><strong>High negative predictive value of 99% <\/strong>for high-grade disease detection<\/li>\n<\/ul>\n<p><span>The DaBlaCa-15 trial, while providing significant insights into non-muscle-invasive bladder cancer (NMIBC) follow-up, acknowledged several limitations:<\/span><\/p>\n<ul>\n<li><strong>Lower-than-expected rate of high-grade recurrence<\/strong>: the trial anticipated a 50% recurrence rate based on historical data, but observed rates were 12.6% in the intervention arm and 11.2% in the control arm, which is lower than what is known from the literature [2]<\/li>\n<li><strong>The<\/strong> <strong>follow-up duration was limited to 2 years<\/strong>, which may not be long enough to fully assess long-term oncological safety of the alternating strategy<\/li>\n<li><strong>Only the XBCM test was investigated<\/strong>, which limits the generalisability of the results to other urinary biomarkers<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><span style=\"font-size: medium\"><strong><span lang=\"EN-GB\">Prof. Fred Witjes expert commentary on adapting guidelines <\/span><\/strong><\/span><\/p>\n<p><span>In his editorial accompanying the DaBlaCa-15 trial results, <strong>Prof. Fred Witjes strongly advocates for a shift in NMIBC follow-up guidelines<\/strong>, declaring, <strong>&#8220;I think the future has arrived&#8221; <\/strong>for the implementation of urinary molecular markers [3].<\/span><\/p>\n<p><span>Prof. Witjes emphasises that the trial results <strong>&#8220;underline the value of urinary markers in follow-up for patients with NMIBC&#8221;<\/strong>. He directly addresses the European Association of Urology (EAU) guidelines&#8217; previous cautious stance on urinary markers replacing cystoscopy, arguing that the <strong>&#8220;anticipatory positive&#8221; phenomenon observed in DaBlaCa-15 reframes what might be considered &#8220;false positives&#8221;<\/strong>. Instead, these positive results indicate <strong>&#8220;detection of changes related to recurrences that will occur in the near future&#8221;<\/strong> and can <strong>&#8220;predict future recurrences,&#8221;<\/strong> aiding in tailoring follow-up. This anticipatory positive phenomenon is not unique to DaBlaCa<\/span>\u2011<span>15. In a North American <strong>trial with Bladder EpiCheck, patients who had a negative cystoscopy, but a positive biomarker test were 5.3 times more likely to experience recurrence at 12 months<\/strong> than those with a negate cystoscopy and biomarker test [4].<\/span><\/p>\n<p><span>He further highlights the <strong>significant economic implications<\/strong>. The demonstrated <strong>reduction in cystoscopies<\/strong> by DaBlaCa-15 logically leads to <strong>cost savings<\/strong> and <strong>reduced patient burden<\/strong>. Witjes points to his own clinical experience since the COVID-19 pandemic, which showed that <strong>alternating cystoscopy with Bladder EpiCheck home testing was found to be safe, cost-effective, and convenient<\/strong>, leading to reimbursement approval in the Netherlands.<\/span><\/p>\n<p><span><\/span><\/p>\n<p><span style=\"font-size: medium\"><strong>Conclusion<\/strong><\/span><\/p>\n<p><span>The DaBlaCa-15 trial provides <strong>additional evidence<\/strong> supporting the oncological safety of alternating flexible cystoscopy with a urinary biomarker test <\/span><span>[1]. These findings have the potential to <strong>significantly influence future clinical guidelines for NMIBC surveillance<\/strong>, moving towards a safe, cost-effective, and patient-convenient follow-up strategy [3].<\/span><\/p>\n<p><span><\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.16&#8243; custom_margin=&#8221;||-6px|||&#8221; custom_padding=&#8221;0px||0px|||&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_row _builder_version=&#8221;4.16&#8243; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_text _builder_version=&#8221;4.16&#8243; header_text_color=&#8221;#3b8dbf&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; min_height=&#8221;191.8px&#8221; custom_margin=&#8221;45px|||||&#8221; custom_padding=&#8221;0px|||||&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;]<\/p>\n<h5>[References]<\/h5>\n<ol>\n<li style=\"text-align: justify\">Dreyer T, Brandt S, Fabrin K, et al. Eur Urol 2025;88:23-30. <span><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/40280776\/\" target=\"_blank\" rel=\"noopener noreferrer\">PubMed<\/a><\/span><\/li>\n<li style=\"text-align: justify\">Gontero P, Birtle A, Comp\u00e9rat E, et al. European Association of Urology (EAU) guidelines on non-muscle-invasive bladder cancer (TaT1 and CIS). Update March 2025. Available at: <span><a href=\"https:\/\/uroweb.org\/guideline\/non-muscle-invasive-bladder-cancer\/\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/uroweb.org\/guideline\/non-muscle-invasive-bladder-cancer\/<\/a><\/span><\/li>\n<li style=\"text-align: justify\"><span><\/span><span> <\/span>Witjes JA. Eur Urol 2025;88:31-32. <span><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/40287360\/\" target=\"_blank\" rel=\"noopener noreferrer\">PubMed<\/a><\/span><\/li>\n<li style=\"text-align: justify\">Fleshner N, Grossman HB, Berglund R, et al. Bladder Cancer 2025;10:278-89. <span><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/40035078\/\" target=\"_blank\" rel=\"noopener noreferrer\">PubMed<\/a><\/span><\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.8.2&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;2px||5px|||&#8221; global_module=&#8221;303&#8243; saved_tabs=&#8221;all&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The DaBlaCa-15 trial paves the way for urinary biomarker integrationReviewed by Joost Boormans &nbsp; Non-muscle-invasive bladder cancer (NMIBC) demands diligent and often lifelong surveillance, primarily through frequent cystoscopies. While crucial for detecting recurrences, this intensive follow-up is invasive, can cause discomfort and anxiety for patients, and contributes significantly to healthcare costs. In addition, the use [&hellip;]<\/p>\n","protected":false},"author":0,"featured_media":290,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[9],"tags":[],"class_list":["post-351","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-publication"],"_links":{"self":[{"href":"https:\/\/bcamonitor.org\/index.php?rest_route=\/wp\/v2\/posts\/351","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bcamonitor.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bcamonitor.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/bcamonitor.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=351"}],"version-history":[{"count":1,"href":"https:\/\/bcamonitor.org\/index.php?rest_route=\/wp\/v2\/posts\/351\/revisions"}],"predecessor-version":[{"id":360,"href":"https:\/\/bcamonitor.org\/index.php?rest_route=\/wp\/v2\/posts\/351\/revisions\/360"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bcamonitor.org\/index.php?rest_route=\/wp\/v2\/media\/290"}],"wp:attachment":[{"href":"https:\/\/bcamonitor.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=351"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bcamonitor.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=351"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bcamonitor.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=351"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}