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(PDF) A phase 3, open-label, multicenter study of a 6-month pre-mixed depot formulation of leuprolide mesylate in advanced prostate cancer patients

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"https://www.academia.edu/login?post_login_redirect_url=https%3A%2F%2Fwww.academia.edu%2F90996455%2FA_phase_3_open_label_multicenter_study_of_a_6_month_pre_mixed_depot_formulation_of_leuprolide_mesylate_in_advanced_prostate_cancer_patients%3Fshow_translation%3Dtrue"; window.loswp.previewableAttachments = [{"id":94406937,"identifier":"Attachment_94406937","shouldShowBulkDownload":false}]; window.loswp.shouldDetectTimezone = true; window.loswp.shouldShowBulkDownload = true; window.loswp.showSignupCaptcha = false window.loswp.willEdgeCache = false; window.loswp.work = {"work":{"id":90996455,"created_at":"2022-11-17T06:37:26.018-08:00","from_world_paper_id":220541383,"updated_at":"2024-11-30T10:40:49.170-08:00","_data":{"publisher":"Springer Science and Business Media LLC","ai_title_tag":"Efficacy and Safety of Leuprolide Mesylate in Advanced Prostate Cancer","grobid_abstract":"Objectives To determine the safety, efficacy and pharmacokinetic (PK) profile of a pre-mixed depot formulation of leuprolide mesylate subcutaneous injectable suspension (LMIS) 50 mg for up to 1 year of treatment for subjects with advanced prostate cancer. Patients and methods In this open-label, multicenter study, prostate cancer patients with indication for androgen ablation therapy received two subcutaneous injection of LMIS 50 mg 6 months apart and were followed for an additional 6 months. Two efficacy primary end points were the percentage of subjects with a serum testosterone level ≤ 50 ng/dL by Day 28 as well as the percentage of subjects with similar testosterone suppression from Day 28 to Day 336. Results Of the 137 enrolled subjects, 15 (10.9%) subjects did not complete the study, including 5 subjects who terminated early due to an adverse event. By Day 28, 98.5% (95% confidence interval 94.8-99.8) of the subjects achieved a castrate testosterone level. At the end of the study, 97% and 95.9% of the subjects had serum testosterone level ≤ 50 ng/dL and ≤ 20 ng/ dL, respectively. LMIS 50 mg significantly reduced serum prostate-specific antigen levels after its first injection and this PSA declination effect remained until the end of the study. No statistically significant change was observed in worsening bone pain or urinary symptom assessments during the study. Hot flush (48.9%) and hypertension (14.6%) were the two most common adverse events reported. Conclusions LMIS 50 mg, administered at 6-month intervals, effectively suppressed serum testosterone level, and demonstrated a consistent safety profile.","publication_date":"2019,,","publication_name":"World Journal of Urology","grobid_abstract_attachment_id":"94406936"},"document_type":"paper","pre_hit_view_count_baseline":null,"quality":"high","language":"en","title":"A phase 3, open-label, multicenter study of a 6-month pre-mixed depot formulation of leuprolide mesylate in advanced prostate cancer patients","broadcastable":true,"draft":null,"has_indexable_attachment":true,"indexable":true}}["work"]; window.loswp.workCoauthors = [231568456]; window.loswp.locale = "en"; window.loswp.countryCode = "SG"; window.loswp.cwvAbTestBucket = ""; window.loswp.designVariant = "ds_vanilla"; window.loswp.fullPageMobileSutdModalVariant = "full_page_mobile_sutd_modal"; window.loswp.useOptimizedScribd4genScript = false; window.loginModal = {}; window.loginModal.appleClientId = 'edu.academia.applesignon'; window.userInChina = "false";</script><script defer="" src="https://accounts.google.com/gsi/client"></script><div class="ds-loswp-container"><div class="ds-work-card--grid-container"><div class="ds-work-card--container js-loswp-work-card"><div class="ds-work-card--cover"><div class="ds-work-cover--wrapper"><div class="ds-work-cover--container"><button class="ds-work-cover--clickable js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;swp-splash-paper-cover&quot;,&quot;attachmentId&quot;:94406937,&quot;attachmentType&quot;:&quot;pdf&quot;}"><img alt="First page of “A phase 3, open-label, multicenter study of a 6-month pre-mixed depot formulation of leuprolide mesylate in advanced prostate cancer patients”" class="ds-work-cover--cover-thumbnail" src="https://0.academia-photos.com/attachment_thumbnails/94406937/mini_magick20221117-1-3oljcb.png?1668696131" /><img alt="PDF Icon" class="ds-work-cover--file-icon" src="//a.academia-assets.com/images/single_work_splash/adobe_icon.svg" /><div class="ds-work-cover--hover-container"><span class="material-symbols-outlined" style="font-size: 20px" translate="no">download</span><p>Download Free PDF</p></div><div class="ds-work-cover--ribbon-container">Download Free PDF</div><div class="ds-work-cover--ribbon-triangle"></div></button></div></div></div><div class="ds-work-card--work-information"><h1 class="ds-work-card--work-title">A phase 3, open-label, multicenter study of a 6-month pre-mixed depot formulation of leuprolide mesylate in advanced prostate cancer patients</h1><div class="ds-work-card--work-authors ds-work-card--detail"><a class="ds-work-card--author js-wsj-grid-card-author ds2-5-body-md ds2-5-body-link" data-author-id="231568456" href="https://independent.academia.edu/YishengLee5"><img alt="Profile image of Yisheng Lee" class="ds-work-card--author-avatar" src="//a.academia-assets.com/images/s65_no_pic.png" />Yisheng Lee</a></div><div class="ds-work-card--detail"><p class="ds-work-card--detail ds2-5-body-sm">2019, World Journal of Urology</p><div class="ds-work-card--work-metadata"><div class="ds-work-card--work-metadata__stat"><span class="material-symbols-outlined" style="font-size: 20px" translate="no">visibility</span><p class="ds2-5-body-sm" id="work-metadata-view-count">…</p></div><div class="ds-work-card--work-metadata__stat"><span class="material-symbols-outlined" style="font-size: 20px" translate="no">description</span><p class="ds2-5-body-sm">9 pages</p></div><div class="ds-work-card--work-metadata__stat"><span class="material-symbols-outlined" style="font-size: 20px" translate="no">link</span><p class="ds2-5-body-sm">1 file</p></div></div><script>(async () => { const workId = 90996455; 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if (!viewCountBody) { throw new Error('Failed to find work views element'); } viewCountBody.textContent = `${commaizedViewCount} views`; } catch (error) { // Remove the whole views element if there was some issue parsing. document.getElementById('work-metadata-view-count')?.parentNode?.remove(); throw new Error(`Failed to parse view count: ${viewCount}`, error); } }; // If the DOM is still loading, wait for it to be ready before updating the view count. if (document.readyState === "loading") { document.addEventListener('DOMContentLoaded', () => { updateViewCount(viewCount); }); // Otherwise, just update it immediately. } else { updateViewCount(viewCount); } })();</script></div><p class="ds-work-card--work-abstract ds-work-card--detail ds2-5-body-md">Objectives To determine the safety, efficacy and pharmacokinetic (PK) profile of a pre-mixed depot formulation of leuprolide mesylate subcutaneous injectable suspension (LMIS) 50 mg for up to 1 year of treatment for subjects with advanced prostate cancer. Patients and methods In this open-label, multicenter study, prostate cancer patients with indication for androgen ablation therapy received two subcutaneous injection of LMIS 50 mg 6 months apart and were followed for an additional 6 months. Two efficacy primary end points were the percentage of subjects with a serum testosterone level ≤ 50 ng/dL by Day 28 as well as the percentage of subjects with similar testosterone suppression from Day 28 to Day 336. Results Of the 137 enrolled subjects, 15 (10.9%) subjects did not complete the study, including 5 subjects who terminated early due to an adverse event. By Day 28, 98.5% (95% confidence interval 94.8-99.8) of the subjects achieved a castrate testosterone level. At the end of the study, 97% and 95.9% of the subjects had serum testosterone level ≤ 50 ng/dL and ≤ 20 ng/ dL, respectively. LMIS 50 mg significantly reduced serum prostate-specific antigen levels after its first injection and this PSA declination effect remained until the end of the study. No statistically significant change was observed in worsening bone pain or urinary symptom assessments during the study. Hot flush (48.9%) and hypertension (14.6%) were the two most common adverse events reported. Conclusions LMIS 50 mg, administered at 6-month intervals, effectively suppressed serum testosterone level, and demonstrated a consistent safety profile.</p><div class="ds-work-card--button-container"><button class="ds2-5-button js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;continue-reading-button--work-card&quot;,&quot;attachmentId&quot;:94406937,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;workUrl&quot;:&quot;https://www.academia.edu/90996455/A_phase_3_open_label_multicenter_study_of_a_6_month_pre_mixed_depot_formulation_of_leuprolide_mesylate_in_advanced_prostate_cancer_patients&quot;}">See full PDF</button><button class="ds2-5-button ds2-5-button--secondary js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;download-pdf-button--work-card&quot;,&quot;attachmentId&quot;:94406937,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;workUrl&quot;:&quot;https://www.academia.edu/90996455/A_phase_3_open_label_multicenter_study_of_a_6_month_pre_mixed_depot_formulation_of_leuprolide_mesylate_in_advanced_prostate_cancer_patients&quot;}"><span class="material-symbols-outlined" style="font-size: 20px" translate="no">download</span>Download PDF</button></div><div class="ds-signup-banner-trigger-container"><div class="ds-signup-banner-trigger ds-signup-banner-trigger-control"></div></div><div class="ds-signup-banner ds-signup-banner-control"><div id="ds-signup-banner-close-button"><button class="ds2-5-button ds2-5-button--secondary ds2-5-button--inverse"><span class="material-symbols-outlined" style="font-size: 20px" translate="no">close</span></button></div><div class="ds-signup-banner-ctas" data-impression-entity-id="90996455" data-impression-entity-type="2" data-impression-source="signup-banner"><img src="//a.academia-assets.com/images/academia-logo-capital-white.svg" /><h4 class="ds2-5-heading-serif-sm">Sign up for access to the world's latest research</h4><button class="ds2-5-button ds2-5-button--inverse ds2-5-button--full-width js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;signup-banner&quot;}">Sign up for free<span class="material-symbols-outlined" style="font-size: 20px" translate="no">arrow_forward</span></button></div><div class="ds-signup-banner-divider"></div><div class="ds-signup-banner-reasons"><div class="ds-signup-banner-reasons-item"><span class="material-symbols-outlined" style="font-size: 24px" translate="no">check</span><span>Get notified about relevant papers</span></div><div class="ds-signup-banner-reasons-item"><span class="material-symbols-outlined" style="font-size: 24px" translate="no">check</span><span>Save papers to use in your research</span></div><div class="ds-signup-banner-reasons-item"><span class="material-symbols-outlined" style="font-size: 24px" translate="no">check</span><span>Join the discussion with peers</span></div><div class="ds-signup-banner-reasons-item"><span class="material-symbols-outlined" style="font-size: 24px" translate="no">check</span><span>Track your impact</span></div></div></div><script>(() => { // Set up signup banner show/hide behavior: // 1. 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Objective: This study investigated the effectiveness, pharmacokinetics, and safety profile of a 1-month leuprolide acetate 3.75-mg depot formulation for suppressing testosterone concentrations in patients with prostate cancer. Methods: This was a Phase III, open-label, international multicenter clinical trial. Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot. Plasma testosterone concentrations were determined at specific times throughout the study. The primary end point was the proportion of successful patients over the total number of evaluable patients (ie, patients with evaluable testosterone concentrations at all monthly assessments and no missing values due to treatment-related adverse events). Treatment success was defined as testosterone suppression below the clinical castration level (ie, ≤0.5 ng/mL) at day 28 and maintenance of clinical castration until study completion (day 168). The frequency of patients with testosterone concentrations ≤0.2 ng/mL was also studied. Results: The study included 160 patients with a mean (SD) age of 71.6 (9.2) years, weight of 83.7 (15.5) kg, and predominantly white race (87.5% [140/160]). All 160 patients received at least one dose of study drug; 157 of them were fully evaluable, and 152 completed the study. The proportion of successful patients over the total number of evaluable patients was 96.8% (152/157; 95% CI, 92.7% 99.0%). Five of the 157 evaluable patients (3.2%) did not achieve the primary end point of testosterone concentration ≤0.5 ng/mL by day 28. Of the evaluable patients, 78.7% (122/155) achieved testosterone suppression by day 21. By day 28, 96.8% (151/156) of the evaluable patients had achieved castrate levels, and 73.1% (114/156) achieved testosterone concentrations ≤0.2 ng/mL. At study end, 100% (152/152) of the patients completing the study maintained castrate levels, and 92.8% (141/152) had testosterone concentrations ≤0.2 ng/mL. The pharmacokinetic profile of leuprolide during the first 3 months</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;Effectiveness, pharmacokinetics, and safety of a new sustained-release leuprolide acetate 3.75-mg depot formulation for testosterone suppression in patients with prostate cancer: A phase III, open-label, international multicenter study&quot;,&quot;attachmentId&quot;:73667974,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/60055549/Effectiveness_pharmacokinetics_and_safety_of_a_new_sustained_release_leuprolide_acetate_3_75_mg_depot_formulation_for_testosterone_suppression_in_patients_with_prostate_cancer_A_phase_III_open_label_international_multicenter_study&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/60055549/Effectiveness_pharmacokinetics_and_safety_of_a_new_sustained_release_leuprolide_acetate_3_75_mg_depot_formulation_for_testosterone_suppression_in_patients_with_prostate_cancer_A_phase_III_open_label_international_multicenter_study"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="1" data-entity-id="101828174" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/101828174/Intramuscular_depot_formulations_of_leuprolide_acetate_suppress_testosterone_levels_below_a_20_ng_dL_threshold_a_retrospective_analysis_of_two_Phase_III_studies">Intramuscular depot formulations of leuprolide acetate suppress testosterone levels below a 20 ng/dL threshold: a retrospective analysis of two Phase III studies</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="26598805" href="https://uci.academia.edu/aaronspitz">aaron spitz</a></div><p class="ds-related-work--metadata ds2-5-body-xs">Research and reports in urology, 2016</p><p class="ds-related-work--abstract ds2-5-body-sm">Androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) analogs is a standard treatment for advanced prostate cancer. GnRH analog therapy can reduce testosterone to &amp;quot;castrate&amp;quot; levels, historically defined as &amp;lt;50 ng/dL. With the advent of newer assays, a lower threshold of &amp;lt;20 ng/dL has recently been proposed. We report the results of a retrospective analysis of two Phase III trials of 4- and 6-month depot microsphere formulations of leuprolide acetate (LA), a GnRH agonist that has previously demonstrated efficacy in testosterone suppression to &amp;lt;50 ng/dL in patients on ADT. This analysis investigates the ability of these LA formulations to suppress to ≤20 ng/dL levels. In two of five AbbVie/Abbott clinical trials of microsphere formulations of LA for ADT, analytic technology permitting testosterone detection as low as 3 ng/dL was used and thus was selected for this analysis. Both trials were open-label, fixed-dose studies in prostate cancer pa...</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;Intramuscular depot formulations of leuprolide acetate suppress testosterone levels below a 20 ng/dL threshold: a retrospective analysis of two Phase III studies&quot;,&quot;attachmentId&quot;:102260691,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/101828174/Intramuscular_depot_formulations_of_leuprolide_acetate_suppress_testosterone_levels_below_a_20_ng_dL_threshold_a_retrospective_analysis_of_two_Phase_III_studies&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/101828174/Intramuscular_depot_formulations_of_leuprolide_acetate_suppress_testosterone_levels_below_a_20_ng_dL_threshold_a_retrospective_analysis_of_two_Phase_III_studies"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="2" data-entity-id="16495285" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/16495285/An_eight_month_clinical_study_of_LA_2575_30_0_mg_a_new_4_month_subcutaneous_delivery_system_for_leuprolide_acetate_in_the_treatment_of_prostate_cancer">An eight-month clinical study of LA-2575 30.0 mg: a new 4-month, subcutaneous delivery system for leuprolide acetate in the treatment of prostate cancer</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="35719880" href="https://independent.academia.edu/FranklinChu2">Franklin Chu</a></div><p class="ds-related-work--metadata ds2-5-body-xs">Urology, 2003</p><p class="ds-related-work--abstract ds2-5-body-sm">Objectives. To investigate the safety, efficacy, and pharmacokinetics of a new 4-month subcutaneous depot of leuprolide acetate in patients with prostate cancer. Methods. Ninety patients diagnosed with adenocarcinoma of the prostate were enrolled in an open-label, multicenter study. LA-2575 30.0 mg was administered subcutaneously once every 4 months for 8 months. The primary efficacy parameter was a serum testosterone level of 50 ng/dL or less. The pharmacokinetics of leuprolide acetate were analyzed in the first 24 enrolled patients. The values are reported as the mean Ϯ standard error. Results. Of 90 enrolled patients, 82 (91%) completed the 8-month study. Eight patients voluntarily withdrew from the study for the following reasons: nonmedical reasons (n ϭ 3), treatment-related adverse events (n ϭ 3), disease progression (n ϭ 1), and cardiovascular disease (n ϭ 1). By day 28, 85 (94%) of the 90 patients had achieved a serum testosterone level less than 50 ng/dL. At study completion, 88 (98%) of the 90 patients had a testosterone value less than the castrate level (mean 12.4 Ϯ 0.8 ng/dL), with 81 (90%) at less than 20 ng/dL. From baseline to month 6, the mean luteinizing hormone level had decreased from 7.51 Ϯ 0.69 mIU/mL to 0.12 Ϯ 0.02 mIU/mL. The mean prostate-specific antigen level had decreased 90% from 13.2 Ϯ 2.0 ng/mL at baseline to 1.3 Ϯ 0.3 ng/mL at 8 months. No clinically significant flare reactions were observed. The most common treatment-related adverse event was mild hot flashes. Conclusions. LA-2575 30.0-mg depot consistently produced and maintained safe and effective suppression of serum testosterone, with total serum testosterone concentrations well below the medical castrate level of less than 50 ng/dL. UROLOGY 62: 319-323, 2003.</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;An eight-month clinical study of LA-2575 30.0 mg: a new 4-month, subcutaneous delivery system for leuprolide acetate in the treatment of prostate cancer&quot;,&quot;attachmentId&quot;:42497532,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/16495285/An_eight_month_clinical_study_of_LA_2575_30_0_mg_a_new_4_month_subcutaneous_delivery_system_for_leuprolide_acetate_in_the_treatment_of_prostate_cancer&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/16495285/An_eight_month_clinical_study_of_LA_2575_30_0_mg_a_new_4_month_subcutaneous_delivery_system_for_leuprolide_acetate_in_the_treatment_of_prostate_cancer"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="3" data-entity-id="6934362" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/6934362/A_Clinical_Study_Of_22_5_mg_La2550_A_New_Subcutaneous_Depot_Delivery_System_For_Leuprolide_Acetate_For_The_Treatment_Of_Prostate_Cancer">A Clinical Study Of 22.5 mg. La2550: A New Subcutaneous Depot Delivery System For Leuprolide Acetate For The Treatment Of Prostate Cancer</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="11703924" href="https://independent.academia.edu/RamonPerez4">Ramon Perez</a></div><p class="ds-related-work--metadata ds2-5-body-xs">Journal of Urology, 2002</p><p class="ds-related-work--abstract ds2-5-body-sm">Purpose: The safety, efficacy and pharmacokinetics of a unique 3-month subcutaneous depot of leuprolide acetate were investigated in patients with prostate cancer.</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;A Clinical Study Of 22.5 mg. La2550: A New Subcutaneous Depot Delivery System For Leuprolide Acetate For The Treatment Of Prostate Cancer&quot;,&quot;attachmentId&quot;:48661817,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/6934362/A_Clinical_Study_Of_22_5_mg_La2550_A_New_Subcutaneous_Depot_Delivery_System_For_Leuprolide_Acetate_For_The_Treatment_Of_Prostate_Cancer&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/6934362/A_Clinical_Study_Of_22_5_mg_La2550_A_New_Subcutaneous_Depot_Delivery_System_For_Leuprolide_Acetate_For_The_Treatment_Of_Prostate_Cancer"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="4" data-entity-id="88285158" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/88285158/Effectiveness_of_Subcutaneously_Administered_Leuprolide_Acetate_to_Achieve_Low_Nadir_Testosterone_in_Prostate_Cancer_Patients">Effectiveness of Subcutaneously Administered Leuprolide Acetate to Achieve Low Nadir Testosterone in Prostate Cancer Patients</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="40578657" href="https://independent.academia.edu/RenzulliJ">J. Renzulli</a></div><p class="ds-related-work--metadata ds2-5-body-xs">Reviews in urology, 2018</p><p class="ds-related-work--abstract ds2-5-body-sm">Evidence suggests lower nadir testosterone levels during the first year of androgen deprivation therapy improve advanced prostate cancer clinical outcomes. We evaluated pivotal trials for subcutaneously administered leuprolide acetate (1-, 3-, 4-, and 6-month doses) to determine nadir testosterone levels. Pooled analysis showed 99%, 97%, and 91% of patients reached nadir testosterone ≤20, ≤10, and ≤5 ng/dL respectively (median ≤3 ng/dL). Across all available categories, $88% of patients reached nadir testosterone ≤5 ng/dL, and &amp;lt;3% experienced a microsurge. Achievement and maintenance of low nadir testosterone levels may improve progression-free survival and time to onset of castrate-resistant prostate cancer.</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;Effectiveness of Subcutaneously Administered Leuprolide Acetate to Achieve Low Nadir Testosterone in Prostate Cancer Patients&quot;,&quot;attachmentId&quot;:92287015,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/88285158/Effectiveness_of_Subcutaneously_Administered_Leuprolide_Acetate_to_Achieve_Low_Nadir_Testosterone_in_Prostate_Cancer_Patients&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/88285158/Effectiveness_of_Subcutaneously_Administered_Leuprolide_Acetate_to_Achieve_Low_Nadir_Testosterone_in_Prostate_Cancer_Patients"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="5" data-entity-id="7096753" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/7096753/Efficacy_and_safety_of_long_acting_intramuscular_testosterone_undecanoate_in_aging_men_a_randomised_controlled_study">Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="12193877" href="https://malaya.academia.edu/KhooEeMing">Khoo Ee Ming</a></div><p class="ds-related-work--metadata ds2-5-body-xs">BJU international, 2013</p><p class="ds-related-work--abstract ds2-5-body-sm">ObjectiveTo evaluate the efficacy and safety of long-acting i.m. testosterone undecanoate (TU) in Malaysian men with testosterone deficiency (TD).To evaluate the efficacy and safety of long-acting i.m. testosterone undecanoate (TU) in Malaysian men with testosterone deficiency (TD).Patients and MethodsA total of 120 men, aged 40–70 years, with TD (serum total testosterone [TT] ≤ 12 nmol/L) were randomised to receive either i.m. TU (1000 mg) or placebo.In all, 58 and 56 men in the placebo and treatment arm, respectively, completed the study.Participants were seen six times in the 48-week period and the following data were collected: physical examination results, haemoglobin, haematocrit, TT, lipid profile, fasting blood glucose, sex hormone-binding globulin, liver function test, prostate- specific antigen (PSA) and adverse events.A total of 120 men, aged 40–70 years, with TD (serum total testosterone [TT] ≤ 12 nmol/L) were randomised to receive either i.m. TU (1000 mg) or placebo.In all, 58 and 56 men in the placebo and treatment arm, respectively, completed the study.Participants were seen six times in the 48-week period and the following data were collected: physical examination results, haemoglobin, haematocrit, TT, lipid profile, fasting blood glucose, sex hormone-binding globulin, liver function test, prostate- specific antigen (PSA) and adverse events.ResultsThe mean (sd) age of the participants was 53.4 (7.6) years.A significant increase in serum TT (P &lt; 0.001), PSA (P = 0.010), haematocrit (P &lt; 0.001), haemoglobin (P &lt; 0.001) and total bilirubin (P = 0.001) were seen in the treatment arm over the 48-week period.Two men in the placebo arm and one man in the treatment arm developed myocardial infarction.Common adverse events observed in the treatment arm included itching/swelling/pain at the site of injection, flushing and acne.Overall, TU injections were well tolerated.The mean (sd) age of the participants was 53.4 (7.6) years.A significant increase in serum TT (P &lt; 0.001), PSA (P = 0.010), haematocrit (P &lt; 0.001), haemoglobin (P &lt; 0.001) and total bilirubin (P = 0.001) were seen in the treatment arm over the 48-week period.Two men in the placebo arm and one man in the treatment arm developed myocardial infarction.Common adverse events observed in the treatment arm included itching/swelling/pain at the site of injection, flushing and acne.Overall, TU injections were well tolerated.ConclusionsTU significantly increases serum testosterone in men with TD.PSA, haemoglobin and haematocrit were significantly elevated but were within clinically safe limits.There was no significant adverse reaction that led to the cessation of treatment.TU significantly increases serum testosterone in men with TD.PSA, haemoglobin and haematocrit were significantly elevated but were within clinically safe limits.There was no significant adverse reaction that led to the cessation of treatment.</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study&quot;,&quot;attachmentId&quot;:48601422,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/7096753/Efficacy_and_safety_of_long_acting_intramuscular_testosterone_undecanoate_in_aging_men_a_randomised_controlled_study&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/7096753/Efficacy_and_safety_of_long_acting_intramuscular_testosterone_undecanoate_in_aging_men_a_randomised_controlled_study"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="6" data-entity-id="105431726" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/105431726/Efficacy_of_Leuprorelide_acetate_Eligard_in_daily_practice_in_Brazil_a_retrospective_study_with_depot_formulations_in_patients_with_prostate_cancer">Efficacy of Leuprorelide acetate (Eligard®) in daily practice in Brazil: a retrospective study with depot formulations in patients with prostate cancer</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="262764506" href="https://independent.academia.edu/SOARESALEIDA">ALEIDA SOARES</a></div><p class="ds-related-work--metadata ds2-5-body-xs">International braz j urol, 2020</p><p class="ds-related-work--abstract ds2-5-body-sm">Introduction: Androgen deprivation therapy (ADT) is the mainstay of therapy for advanced prostate cancer. Studies addressing the effi cacy of different depot formulations of long acting luteinizing hormone releasing hormone agonists in the Brazilian population are lacking. We aimed to compare the effi cacy of three schedules of leuprolide acetate in lowering PSA in a real world population. Materials and Methods: We reviewed the medical records of patients with prostate cancer seen at our institution between January 2007 and July 2018. We analyzed patients treated with long-acting leuprolide acetate and grouped these patients into three strata according to the administration of ADT every 1, 3 or 6 months. The primary outcome was the serum prostate specifi c antigen (PSA) levels at 6 and 12 months after treatment initiation. We used Friedman test to compare the distribution of PSA levels at baseline and at 6 and 12 months within each treatment stratum. We considered two-sided P values &lt;0.05 as statistically signifi cant. We analyzed toxicity descriptively. Results: We analyzed a total of 932 patients, with a median age of 72 years and a median time since diagnosis of prostate cancer of 8.5 months. ADT was administered monthly in 115 patients, quarterly in 637, and semiannually in 180. Nearly half of the patients had locally advanced disease. In comparison with baseline, median serum PSA levels were reduced at 12 months by at least 99.7% in the three strata (P &lt;0.001 in all cases). Sexual impotence and hot fl ashes were the most frequently reported toxicities. Conclusion: To our knowledge, this is the largest assessment of real-world data on alternative schedules of leuprolide in a Brazilian population. Our study suggests that PSA levels can be effectively be reduced in most patients treated with monthly, quarterly, or semiannual injections of long-acting leuprolide acetate.</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;Efficacy of Leuprorelide acetate (Eligard®) in daily practice in Brazil: a retrospective study with depot formulations in patients with prostate cancer&quot;,&quot;attachmentId&quot;:104888406,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/105431726/Efficacy_of_Leuprorelide_acetate_Eligard_in_daily_practice_in_Brazil_a_retrospective_study_with_depot_formulations_in_patients_with_prostate_cancer&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/105431726/Efficacy_of_Leuprorelide_acetate_Eligard_in_daily_practice_in_Brazil_a_retrospective_study_with_depot_formulations_in_patients_with_prostate_cancer"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="7" data-entity-id="83290445" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/83290445/Liproca_Depot_A_New_Antiandrogen_Treatment_for_Active_Surveillance_Patients">Liproca Depot: A New Antiandrogen Treatment for Active Surveillance Patients</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="42402737" href="https://independent.academia.edu/AlbertasUlys">Albertas Ulys</a></div><p class="ds-related-work--metadata ds2-5-body-xs">European Urology Focus, 2022</p><p class="ds-related-work--abstract ds2-5-body-sm">Background: There is increasing interest in nonmorbid treatments for low-and intermediate-risk prostate cancer with fewer side effects than surgery or radiotherapy. Objective: To investigate the tolerability, safety, and antitumor effects of the intraprostatic NanoZolid depot formulation Liproca Depot (LIDDS AB, Uppsala, Sweden) with antiandrogen 2-hydroxyflutamide (2-HOF) in men with low-or intermediate-risk localized prostate cancer managed with active surveillance. Design, setting, and participants: This clinical phase 2b trial, LPC-004, involved 61 patients. The 2-HOF-containing formulation Liproca Depot was injected transrectally into the prostate under ultrasound guidance. A single dose of 35% or 45% of the prostate volume (study part 1) and a fixed dose of 16 or 20 ml (study part 2) of the formulation were evaluated. Outcome measurements and statistical analyses: The primary endpoints were tolerability and the reduction in serum prostate-specific antigen (PSA) 5 mo after injection. Antitumor effects were evaluated with magnetic resonance imaging (MRI) and prostate biopsies. Quality of life was assessed using a validated questionnaire (International Prostate Symptom Score). Results and limitations: All doses were safe and well tolerated, without hormonal side effects. In part 2 of the study, the PSA reduction was greatest for the group receiving 16 ml, with an average decrease of 14%, and 95% of patients had a PSA reduction. Some 78% of patients showed a prostate volume decrease compared to baseline. Prostate MRI and biopsies confirmed stable or reduced lesion size. However, post treatment biopsies were performed at the discretion of the investigator, and not routinely. Most patients were amenable to a second injection. Conclusions: PSA and prostate volume decreased in most patients. Indications of efficacy were shown by post-treatment MRI and biopsies demonstrating stabilization or regression in the majority of cases.</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;Liproca Depot: A New Antiandrogen Treatment for Active Surveillance Patients&quot;,&quot;attachmentId&quot;:88685426,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/83290445/Liproca_Depot_A_New_Antiandrogen_Treatment_for_Active_Surveillance_Patients&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/83290445/Liproca_Depot_A_New_Antiandrogen_Treatment_for_Active_Surveillance_Patients"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="8" data-entity-id="59853655" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/59853655/Safety_of_a_New_Subcutaneous_Testosterone_Enanthate_Auto_Injector_Results_of_a_26_Week_Study">Safety of a New Subcutaneous Testosterone Enanthate Auto-Injector: Results of a 26-Week Study</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="98306801" href="https://independent.academia.edu/JonathanJaffe2">Jonathan Jaffe</a></div><p class="ds-related-work--metadata ds2-5-body-xs">The Journal of Sexual Medicine</p><p class="ds-related-work--abstract ds2-5-body-sm">Introduction: Patients with testosterone deficiency (TD) can be treated with exogenous testosterone (T) to achieve and maintain physiologic T levels and prevent negative clinical symptoms; with many testosterone replacement therapies currently available, this registration safety study was conducted to further characterize the clinical profile of chronically administered, concentration-guided subcutaneous testosterone enanthate (TE) dosing. Aim: The purpose of this study was to confirm the safety and characterize the pharmacokinetic (PK) profile of the subcutaneous TE auto-injector (SCTE-AI) in adult men with TD. Methods: In this phase III, 26-week study, 133 men 18À75 years of age with symptomatic TD self-administered SCTE-AI 75 mg once weekly for 6 weeks from July 2015 to June 2016. Dosing was adjusted when indicated to 50 mg or 100 mg to maintain T trough levels between 350 and 650 ng/dL (12.1À22.5 nmol/L). PK data were collected from a subgroup of patients receiving 75 mg SCTE-AI through week 12. Safety, including ambulatory blood pressure monitoring (ABPM), lipid levels, and adverse drug reactions, and PK were assessed. Main Outcome Measures: The main outcomes were the documentation of the reproducibility of trough concentration-guided exposure to SCTE, 6-month safety profile, and PK data for the 75 mg dose SCTE. Results: In total, 34 patients (25.6%) experienced adverse drug reactions; the most frequently reported were increased hematocrit (!52%) in 10 patients (7.5%), injection-site hemorrhage in 6 patients (4.5%), injectionsite bruising in 4 patients (3.0%), and increased prostate-specific antigen in 4 patients (3.0%). By week 26, mean systolic and diastolic blood pressure (BP) measured in the clinic increased by 3.4 mmHg (125.6À129.0 mmHg) and 1.8 mmHg (78.2À80.0 mmHg), respectively, from baseline. At week 12, ABPM showed 24-hour mean systolic and diastolic BP increases of 3.7 mmHg and 1.3 mmHg, respectively. All measured lipid fractions were below baseline levels at week 26. T, TE, dihydrotestosterone, and estradiol increased from weeks 1À12. T trough levels ranged from 300À650 ng/dL (10.4À22.5 nmol/L) in 82.4% and 83.2% of patients at weeks 12 and 26, respectively. Of the 965 assessed injections, mild pain was reported by 1 patient. Clinical Implications: Dosing with SCTE is well-tolerated overall, yet associated with a numerically small mean systolic BP increase. Strengths &amp; Implications: This study used a standardized ABPM protocol, confirming a numerically small systolic BP increase may be associated with reintroducing therapeutic T exposure in hypogonadal men. It is unknown at this time whether this applies with all routes of T supplementation. Conclusion: SCTE-AI has a favorable safety profile and is well-tolerated, with a stable PK profile.</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;Safety of a New Subcutaneous Testosterone Enanthate Auto-Injector: Results of a 26-Week Study&quot;,&quot;attachmentId&quot;:73561664,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/59853655/Safety_of_a_New_Subcutaneous_Testosterone_Enanthate_Auto_Injector_Results_of_a_26_Week_Study&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/59853655/Safety_of_a_New_Subcutaneous_Testosterone_Enanthate_Auto_Injector_Results_of_a_26_Week_Study"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="9" data-entity-id="126422312" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/126422312/Study_of_testosterone_guided_androgen_deprivation_therapy_in_management_of_prostate_cancer">Study of testosterone-guided androgen deprivation therapy in management of prostate cancer</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="58591013" href="https://independent.academia.edu/SarojNiraula1">Saroj Niraula</a></div><p class="ds-related-work--metadata ds2-5-body-xs">The Prostate, 2015</p><p class="ds-related-work--abstract ds2-5-body-sm">BACKGROUND. Androgen deprivation therapy (ADT) with luteinizing hormone releasing hormone (LHRH) agonists is an effective initial therapy for men with advanced prostate cancer. LHRH agonists are usually administered indefinitely at a fixed interval. METHODS. We recruited men with advanced prostate cancer who had been on fixedschedule injections of an LHRH agonist for !1 year and had castrate serum testosterone [&lt;1.75 nmol/l (approx. 50 ng/ml)]. Testosterone levels were measured at 6-week intervals and ADT was withheld until testosterone levels were no longer in the castrate range and then reinstituted. Time to reinstitution of ADT was the primary outcome and was analyzed by the Kaplan-Meier method; Cox regression was used to identify factors predicting delay in reinstitution of treatment. Influence on quality-of-life (QoL) was evaluated by the Expanded Prostate Index Composite (EPIC). RESULTS. Forty-six evaluable men who had received LHRH agonist injections every 12 weeks were recruited. Median time to testosterone recovery (defined as testosterone outside the defined castrate level) after previous injection was &gt;1 year. In univariable analysis, lower baseline testosterone [ 1 vs. &gt;1 nmol/l (approx. 30 ng/dl)] and longer time on ADT (&gt;5 vs. 5 years) predicted for prolonged time to testosterone recovery, but only lower baseline testosterone remained significant in multivariable analysis (Hazard Ratio ¼ 5.2, P ¼ 0.03). Overall EPIC scores remained stable but improvement from baseline was observed in the hormonal domain (P ¼ 0.002). Median per-patient saving in cost was approximately USD 3,100 (1,050-6,200). CONCLUSIONS. Testosterone-guided ADT reduces exposure to LHRH agonists, with reduction in cost and improvement in some symptoms from ADT. 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href="https://independent.academia.edu/rafaeladejesus9">rafaela de jesus</a></div><p class="ds-related-work--metadata ds2-5-body-xs">European Journal of Cancer, 2021</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;A phase 2 randomized clinical trial of abiraterone plus ADT, apalutamide, or abiraterone and apalutamide in patients with advanced prostate cancer with non-castrate testosterone levels (LACOG 0415)&quot;,&quot;attachmentId&quot;:98988757,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/97340385/A_phase_2_randomized_clinical_trial_of_abiraterone_plus_ADT_apalutamide_or_abiraterone_and_apalutamide_in_patients_with_advanced_prostate_cancer_with_non_castrate_testosterone_levels_LACOG_0415_&quot;,&quot;alternativeTracking&quot;:true}"><span 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href="https://www.academia.edu/104926797/The_Effect_of_Baseline_Testosterone_on_the_Efficacy_of_Degarelix_and_Leuprolide_Further_Insights_From_A_12_Month_Comparative_Phase_III_Study_in_Prostate_Cancer_Patients">The Effect of Baseline Testosterone on the Efficacy of Degarelix and Leuprolide: Further Insights From A 12-Month, Comparative, Phase III Study in Prostate Cancer Patients</a><div class="ds-related-work--metadata"><a class="js-related-work-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="262823934" href="https://independent.academia.edu/LaurentBocconGibod">Laurent Boccon-Gibod</a></div><p class="ds-related-work--metadata ds2-5-body-xs">Urology, 2012</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;The Effect of Baseline Testosterone on the Efficacy of Degarelix and Leuprolide: Further 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class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;Leuprolide acetate 1-, 3- and 6-monthly depot formulations in androgen deprivation therapy for prostate cancer in nine European countries: evidence review and economic evaluation&quot;,&quot;attachmentId&quot;:31656168,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/4147163/Leuprolide_acetate_1_3_and_6_monthly_depot_formulations_in_androgen_deprivation_therapy_for_prostate_cancer_in_nine_European_countries_evidence_review_and_economic_evaluation&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline 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abiraterone acetate and apalutamide in patients with advanced prostate cancer with non-castration testosterone levels</a><div class="ds-related-work--metadata"><a class="js-related-work-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="199467612" href="https://independent.academia.edu/CronembergerEduardo">Eduardo Cronemberger</a></div><p class="ds-related-work--metadata ds2-5-body-xs">BMC Cancer</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;The LACOG-0415 phase II trial: abiraterone acetate and ADT versus apalutamide versus abiraterone acetate and apalutamide in patients with advanced prostate cancer with non-castration testosterone 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class="ds-related-work--metadata ds2-5-body-xs">The Journal of Clinical Endocrinology &amp; Metabolism, 1999</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;Pharmacokinetics, Efficacy, and Safety of a Permeation-Enhanced Testosterone Transdermal System in Comparison with Bi-Weekly Injections of Testosterone Enanthate for the Treatment of Hypogonadal Men 1&quot;,&quot;attachmentId&quot;:40307698,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/18880961/Pharmacokinetics_Efficacy_and_Safety_of_a_Permeation_Enhanced_Testosterone_Transdermal_System_in_Comparison_with_Bi_Weekly_Injections_of_Testosterone_Enanthate_for_the_Treatment_of_Hypogonadal_Men_1&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" 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treatment of hot flushes in men with prostate cancer</a><div class="ds-related-work--metadata"><a class="js-related-work-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="33383131" href="https://chicago.academia.edu/GregoryZagaja">Gregory Zagaja</a></div><p class="ds-related-work--metadata ds2-5-body-xs">Urology, 2000</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;Transdermal estrogen in the treatment of hot flushes in men with prostate cancer&quot;,&quot;attachmentId&quot;:74980349,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/62139165/Transdermal_estrogen_in_the_treatment_of_hot_flushes_in_men_with_prostate_cancer&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" 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data-author-id="32814273" href="https://hms-harvard.academia.edu/ShalenderBhasin">Shalender Bhasin</a></div><p class="ds-related-work--metadata ds2-5-body-xs">New England Journal of Medicine, 2010</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;Adverse Events Associated with Testosterone Administration&quot;,&quot;attachmentId&quot;:85790450,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/78659474/Adverse_Events_Associated_with_Testosterone_Administration&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-related-work-grid-card-view-pdf" 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href="https://www.academia.edu/12322965/Efficacy_and_safety_of_two_different_testosterone_undecanoate_formulations_in_hypogonadal_men_with_metabolic_syndrome"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-related-work-sidebar-card" data-collection-position="17" data-entity-id="77066782" data-sort-order="default"><a class="ds-related-work--title js-related-work-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/77066782/Comparison_of_serum_testosterone_levels_in_prostate_cancer_patients_receiving_LHRH_agonist_therapy_with_or_without_the_removal_of_the_prostate">Comparison of serum testosterone levels in prostate cancer patients receiving LHRH agonist therapy with or without the removal of the prostate</a><div class="ds-related-work--metadata"><a class="js-related-work-grid-card-author ds2-5-body-sm 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