{"id":374501,"date":"2024-01-24T09:33:18","date_gmt":"2024-01-24T08:33:18","guid":{"rendered":"https:\/\/medizinonline.com\/sustained-testosterone-reduction-without-injections\/"},"modified":"2024-02-02T15:43:29","modified_gmt":"2024-02-02T14:43:29","slug":"sustained-testosterone-reduction-without-injections","status":"publish","type":"post","link":"https:\/\/medizinonline.com\/en\/sustained-testosterone-reduction-without-injections\/","title":{"rendered":"Sustained testosterone reduction without injections"},"content":{"rendered":"\n

Since January 1, 2024, the oral GnRH antagonist Relugolix has been approved in Switzerland for the treatment of adults with advanced hormone-sensitive prostate cancer [1, 2]. This gives patients access to oral androgen deprivation therapy (ADT) for the first time, which promises rapid and sustained testosterone suppression without an initial increase in testosterone and a good safety profile [1, 3].<\/strong><\/p>\n\n\n\n

To date, only injections have been available for ADT in advanced prostate cancer [3, 4]. GnRH agonists such as leuprorelin are frequently used, but these cause an initial testosterone surge [3, 5]. Orgovyx\u00ae (Relugolix) is the first oral ADT option in this setting and, as a GnRH antagonist, leads to rapid testosterone suppression without an initial relapse [1, 3]. Treatment is initiated with a loading dose of 360 mg (3 tablets) on the first day, followed by a dose of 120 mg\/day (1 tablet\/day) with individualized but consistent timing [1].<\/p>\n\n

Rapid and sustained testosterone suppression<\/h5>\n\n

In the phase 3 HERO study, patients with advanced prostate cancer were randomized 2:1 and treated for 48 weeks with either Orgovyx\u00ae (120 mg orally, once daily; N = 622) or leuprorelin (injections every three months; N = 308) [3]. The primary endpoint was the sustained suppression of testosterone to castration levels (<50 ng\/dl) over 48 weeks. Under Orgovyx\u00ae, 96.7 % (95 % confidence interval [KI]: 94.9 – 97.9) of patients maintained castration for 48 weeks, compared with 88.8 % (95 % CI: 84.6 – 91.8) of patients under leuprorelin [3]. In the Orgovyx\u00ae group, there was no initial increase in serum testosterone and by day 4, 56 % of patients reached the castration level of <50 ng\/dl compared to 0 % with leuprorelin (p < 0.001). On day 4, the mean testosterone level was 38 ng\/dl with Orgovyx\u00ae compared to 625 ng\/dl with leuprorelin (Fig. 1) [1, 3].<\/p>\n\n

Rapid restoration of testosterone levels after discontinuation<\/h5>\n\n

In a subgroup of 184 patients, testosterone recovery was monitored after discontinuation of Orgovyx\u00ae vs. leuprorelin therapy [3]. While patients taking Orgovyx\u00ae had a mean testosterone level of 288.4 ng\/dl 90 days after discontinuation, this was 58.6 ng\/dl in the leuprorelin group [3].<\/p>\n\n

Safety comparable to other therapies<\/h5>\n\n

In the HERO study, the overall incidence of adverse events was similar in the Orgovyx\u00ae and leuprorelin treatment groups (92.9% vs. 93.5%) [3]. The most frequently observed adverse effects included hot flushes, fatigue, constipation, diarrhea, arthralgia and hypertension [3].<\/p>\n\n

Conclusion<\/h5>\n\n

In summary, the newly approved therapy with Orgovyx\u00ae is superior to treatment with leuprorelin due to its rapid, sustained suppression of testosterone levels in advanced hormone-sensitive prostate cancer [3]. In addition, Orgovyx\u00ae does not cause an initial increase in testosterone [1, 3] and oral administration can avoid reactions at the injection site, errors during injection preparation and injection phobia. Orgovyx\u00ae therapy has a similar safety profile compared to leuprorelin and can be interrupted or discontinued more easily due to the rapid recovery of testosterone levels after discontinuation [3]. <\/p>\n\n

\"\"<\/a><\/figure>\n\n

Figure 1)<\/strong> Mean serum testosterone levels of patients from baseline to week 48. Compared to leuprorelin (black), Orgovyx\u00ae (yellow) did not produce an initial testosterone surge and there was a rapid, sustained reduction in testosterone levels below the castration level of 50 ng\/dl. Adapted from Shore et al. 2020 [3].<\/p>\n\n

Abbreviations: <\/h5>\n\n

GnRH = gonadotropin-releasing hormone<\/p>\n\n

Approval number: CH-01901 01\/2024<\/p>\n\n

The brief specialist information from ORGOVYX\u00ae<\/a><\/p>\n\n

Literature<\/p>\n\n

1. current ORGOVYX\u00ae Information for healthcare professionals, available at <\/em>: \n www.swissmedicinfo.ch<\/em>\n<\/a>. Current status.<\/em>2. Specialty list Orgovyx\u00ae. Federal Office of Public Health (FOPH). <\/em>\n www.spezialitaetenliste.ch<\/em>\n<\/a>, last accessed: 5.1.2024.<\/em>3 Shore, N.D., et al, Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer<\/em>. N Engl J Med, 2020. 382<\/strong>(23): p. 2187-2196.4 Van Poppel, H. and L. Klotz, Gonadotropin-releasing hormone: an update review of the antagonists versus agonists<\/em>. Int J Urol, 2012. 19<\/strong>(7): p. 594-601.5 Oh, W.K., et al, Does oral antiandrogen use before leuteinizing hormone-releasing hormone therapy in patients with metastatic prostate cancer prevent clinical consequences of a testosterone flare?<\/em> Urology, 2010. 75<\/strong>(3): p. 642-7.<\/p>\n\n

Article online since 24.01.2024<\/p>\n","protected":false},"excerpt":{"rendered":"

Since January 1, 2024, the oral GnRH antagonist Relugolix has been approved in Switzerland for the treatment of adults with advanced hormone-sensitive prostate cancer [1, 2]. This gives patients access…<\/p>\n","protected":false},"author":17,"featured_media":374506,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":"","cat_1_feature_home_top":false,"cat_2_editor_pick":false,"csco_eyebrow_text":"Advanced hormone-sensitive prostate cancer","footnotes":""},"category":[11370,11323,11548,11503,11490],"tags":[17927],"powerkit_post_featured":[],"class_list":["post-374501","post","type-post","status-publish","format-standard","has-post-thumbnail","category-oncology","category-partner-content-en","category-rx-en","category-studies","category-urology","tag-prostate-cancer","pmpro-has-access"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-06-20 13:52:53","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"category","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"wpml_current_locale":"en_US","wpml_translations":{"fr_FR":{"locale":"fr_FR","id":374502,"slug":"reduction-durable-de-la-testosterone-sans-injections","post_title":"R\u00e9duction durable de la testost\u00e9rone sans injections ","href":"https:\/\/medizinonline.com\/fr\/reduction-durable-de-la-testosterone-sans-injections\/"},"it_IT":{"locale":"it_IT","id":374504,"slug":"riduzione-sostenuta-del-testosterone-senza-iniezioni","post_title":"Riduzione sostenuta del testosterone senza iniezioni ","href":"https:\/\/medizinonline.com\/it\/riduzione-sostenuta-del-testosterone-senza-iniezioni\/"},"pt_PT":{"locale":"pt_PT","id":374513,"slug":"reducao-sustentada-da-testosterona-sem-injeccoes","post_title":"Redu\u00e7\u00e3o sustentada da testosterona sem injec\u00e7\u00f5es","href":"https:\/\/medizinonline.com\/pt-pt\/reducao-sustentada-da-testosterona-sem-injeccoes\/"},"es_ES":{"locale":"es_ES","id":374503,"slug":"reduccion-sostenida-de-testosterona-sin-inyecciones","post_title":"Reducci\u00f3n sostenida de testosterona sin inyecciones ","href":"https:\/\/medizinonline.com\/es\/reduccion-sostenida-de-testosterona-sin-inyecciones\/"}},"_links":{"self":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/374501","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/users\/17"}],"replies":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/comments?post=374501"}],"version-history":[{"count":1,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/374501\/revisions"}],"predecessor-version":[{"id":374509,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/374501\/revisions\/374509"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media\/374506"}],"wp:attachment":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media?parent=374501"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/category?post=374501"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/tags?post=374501"},{"taxonomy":"powerkit_post_featured","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/powerkit_post_featured?post=374501"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}