{"id":1112,"date":"2017-12-05T11:19:05","date_gmt":"2017-12-05T16:19:05","guid":{"rendered":"http:\/\/carolinaurologicresearchcenter.com\/?page_id=1112"},"modified":"2024-03-12T23:09:36","modified_gmt":"2024-03-13T03:09:36","slug":"current-trials-prostate-cancer","status":"publish","type":"page","link":"https:\/\/carolinaurologicresearchcenter.com\/current-trials\/current-trials-prostate-cancer\/","title":{"rendered":"Prostate Cancer"},"content":{"rendered":"<div id='av_section_1'  class='avia-section av-69j8iw-e33dd36558f5636a5e14d9cb6d1d92af main_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_textblock  avia-builder-el-first  avia-bg-style-scroll container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-1112'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3zorzs-1a140914444c3c941cbf761b75c97fa7\">\n.flex_column.av-3zorzs-1a140914444c3c941cbf761b75c97fa7{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3zorzs-1a140914444c3c941cbf761b75c97fa7 av_one_full  avia-builder-el-1  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-ko320djr-6b917c5136943cf9b850d76dbb871ce4 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><div id=\"active_surveillance\">\n<h2 data-fontsize=\"22\" data-lineheight=\"27\"><u>Prostate Biopsy<br \/>\n<\/u><\/h2>\n<p data-fontsize=\"23\" data-lineheight=\"23\"><span style=\"color: #808080;\"><strong><span style=\"text-decoration: underline;\">ExactVu OPTIMUM<\/span>: <\/strong>Optimization of Prostate Biopsy &#8211; Micro-Ultrasound versus MRI (OPTIMUM): A 3-arm randomized controlled trial evaluating the role of 29MHz micro-ultrasound in guiding prostate biopsy in men with clinical suspicion of prostate cancer (EVU-2021-001)<\/span><\/p>\n<p data-fontsize=\"20\" data-lineheight=\"24\"><span style=\"color: #808080;\">Phase: N\/A<\/span><br \/>\n<span style=\"color: #808080;\">Study Product: Optimization of prostate biopsy- ExactVu (no MRI) vs Uronav vs ExactVu fusion with MRI- pts must enroll in study before getting MRI<\/span><br \/>\n<span style=\"color: #808080;\">Estimated Study Completion Date: December 2024<\/span><br \/>\n<span style=\"color: #808080;\">ClinicalTrials.gov Identifier:&nbsp;<a style=\"color: #808080;\" href=\"https:\/\/clinicaltrials.gov\/show\/NCT05220501\" target=\"_blank\" rel=\"noopener\">NCT05220501<\/a><\/span><\/p>\n<hr>\n<h2 data-fontsize=\"22\" data-lineheight=\"27\"><u>Favorable Intermediate Risk Prostate Cancer<br \/>\n<\/u><\/h2>\n<p><span style=\"color: #808080;\"><em><strong>Focal Therapy <\/strong><\/em><\/span><\/p>\n<p><span style=\"color: #808080;\"><strong><span style=\"text-decoration: underline;\">Francis Medical Vapor-2<\/span>: <\/strong>Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor<\/span>&nbsp;<span style=\"color: #808080;\">Ablation for PrOstate CanceR<\/span><\/p>\n<p data-fontsize=\"20\" data-lineheight=\"24\"><span style=\"color: #808080;\">Phase: N\/A<\/span><br \/>\n<span style=\"color: #808080;\">Study Product: Vanquish Water Vapor Ablation locatlized FIR PCa (GG 2 &amp; PSA&nbsp;<span style=\"text-decoration: underline;\">&lt;<\/span> 15)<\/span><br \/>\n<span style=\"color: #808080;\">Estimated Study Completion Date: April 2029<\/span><br \/>\n<span style=\"color: #808080;\">ClinicalTrials.gov Identifier:&nbsp;<a style=\"color: #808080;\" href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05683691\" target=\"_blank\" rel=\"noopener\">NCT05683691<\/a><\/span><\/p>\n<hr>\n<h2 data-fontsize=\"22\" data-lineheight=\"27\"><u>Radical Prostatectomy Candidates<\/u><\/h2>\n<p><span style=\"color: #808080;\"><strong><u>Clarity CLARIFY<\/u>:&nbsp;<\/strong>Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy<\/span><\/p>\n<p data-fontsize=\"20\" data-lineheight=\"24\"><span style=\"color: #808080;\">Phase: 3<\/span><br \/>\n<span style=\"color: #808080;\">Study Product: 64Cu-SAR-bisPSMA<\/span><br \/>\n<span style=\"color: #808080;\">Estimated Study Completion Date: February&nbsp; 2025<\/span><br \/>\n<span style=\"color: #808080;\">ClinicalTrials.gov Identifier:&nbsp;<a style=\"color: #808080;\" href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT06056830\" target=\"_blank\" rel=\"noopener\">NCT06056830<\/a><\/span><\/p>\n<hr>\n<h2 data-fontsize=\"20\" data-lineheight=\"24\"><span style=\"text-decoration: underline;\">PSA Relapse<\/span><\/h2>\n<\/div>\n<div id=\"psa_relapse\">\n<p data-fontsize=\"23\" data-lineheight=\"23\"><span style=\"color: #808080;\"><strong><span style=\"text-decoration: underline;\">Vaccitech<\/span>: <\/strong>A Phase 1\/Phase 2 Trial to Evaluate Safety, Immunogenicity and PSA Response of&nbsp;<span class=\"hit_inf\">VTP-850<\/span>&nbsp;Prostate Cancer Immunotherapeutic in Men With Biochemical Recurrence After Definitive Local Therapy for Prostate Cancer<\/span><\/p>\n<p data-fontsize=\"20\" data-lineheight=\"24\"><span style=\"color: #808080;\">Phase: 1\/2<\/span><br \/>\n<span style=\"color: #808080;\">Study Product: VTP-850 (viral vector) prime-boost regimens with booster IM for BCR&nbsp;<\/span><br \/>\n<span style=\"color: #808080;\">Estimated Study Completion Date: April 2027<\/span><br \/>\n<span style=\"color: #808080;\">ClinicalTrials.gov Identifier:&nbsp;<a style=\"color: #808080;\" href=\"https:\/\/clinicaltrials.gov\/show\/NCT05617040\" target=\"_blank\" rel=\"noopener\">NCT05617040<\/a><\/span><\/p>\n<hr>\n<\/div>\n<div id=\"psa_relapse\">\n<div id=\"psa_relapse\">\n<p data-fontsize=\"23\" data-lineheight=\"23\"><span style=\"color: #808080;\"><strong><span style=\"text-decoration: underline;\">ARASTEP<\/span>: <\/strong>A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer<\/span><\/p>\n<p data-fontsize=\"20\" data-lineheight=\"24\"><span style=\"color: #808080;\">Phase: 3<\/span><br \/>\n<span style=\"color: #808080;\">Study Product: Darolutamide (placebo-controlled) + ADT +\/- IGRT for BCR with positive PSMA PET&nbsp;<\/span><br \/>\n<span style=\"color: #808080;\">Estimated Study Completion Date: February 28, 2029<\/span><br \/>\n<span style=\"color: #808080;\">ClinicalTrials.gov Identifier:&nbsp;<a style=\"color: #808080;\" href=\"https:\/\/clinicaltrials.gov\/show\/NCT05794906\" target=\"_blank\" rel=\"noopener\">NCT05794906<\/a><\/span><\/p>\n<hr>\n<\/div>\n<div id=\"psa_relapse\">\n<p data-fontsize=\"20\" data-lineheight=\"24\"><u style=\"font-size: 28px; font-weight: 600;\">MCSPC<\/u><\/p>\n<\/div>\n<\/div>\n<p><span style=\"color: #808080;\"><em><strong>Treatment Na\u00efve<\/strong><\/em><\/span><strong><em><span style=\"color: #808080;\">&nbsp;<\/span><\/em><\/strong><\/p>\n<p data-fontsize=\"23\" data-lineheight=\"23\"><span style=\"color: #808080;\"><strong><span style=\"text-decoration: underline;\">Petranha<\/span>: <\/strong>A Multi-arm, Open-label Phase I\/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD5305 in Combination with New Hormonal Agents in Patients with Metastatic Prostate Cancer (PETRANHA)<\/span><\/p>\n<p data-fontsize=\"20\" data-lineheight=\"24\"><span style=\"color: #808080;\">Phase: 1\/2a<\/span><br \/>\n<span style=\"color: #808080;\">Study Product: Part B cohort 3 Arm 3: AZD5305 (PARPi) + Daro. Pts can start ADT within 4M of consent&nbsp;<\/span><br \/>\n<span style=\"color: #808080;\">Estimated Study Completion Date: June 7, 2030<\/span><br \/>\n<span style=\"color: #808080;\">ClinicalTrials.gov Identifier:&nbsp;<a style=\"color: #808080;\" href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT05367440?term=D361BC00001&amp;draw=2&amp;rank=1\" target=\"_blank\" rel=\"noopener\">NCT05367440<\/a><\/span><\/p>\n<hr>\n<div id=\"psa_relapse\">\n<p data-fontsize=\"23\" data-lineheight=\"23\"><span style=\"color: #808080;\"><strong><span style=\"text-decoration: underline;\">EvoPAR<\/span>: <\/strong>A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician&#8217;s Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (<mark class=\"hl-term\">EvoPAR<\/mark>-Prostate01)<\/span><\/p>\n<p data-fontsize=\"20\" data-lineheight=\"24\"><span style=\"color: #808080;\">Phase: 3<\/span><br \/>\n<span style=\"color: #808080;\">Study Product: AZD5305 (PARPi) (placebo-controlled) + ARTA of MD choice<\/span><br \/>\n<span style=\"color: #808080;\">Estimated Study Completion Date: April 30, 2031<\/span><br \/>\n<span style=\"color: #808080;\">ClinicalTrials.gov Identifier:&nbsp;<a style=\"color: #808080;\" href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT06120491?term=D361BC00001&amp;draw=2&amp;rank=1\" target=\"_blank\" rel=\"noopener\">NCT06120491<\/a><\/span><\/p>\n<hr>\n<h2><span style=\"text-decoration: underline;\">mCSPC or mCRPC<\/span><\/h2>\n<p><span style=\"color: #808080;\"><em><strong>No prior ARTA<\/strong><\/em><\/span><\/p>\n<p data-fontsize=\"23\" data-lineheight=\"23\"><span style=\"color: #808080;\"><b><span style=\"text-decoration: underline;\">ARV-766<\/span>: <\/b>A Phase 1\/2 Open-Label, Dose-Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-766 in Patients with Metastatic Castration-Resistant Prostate Cancer<\/span><\/p>\n<p><span style=\"color: #808080;\">Phase: 1\/2<\/span><br \/>\n<span style=\"color: #808080;\">Study Product: no prior ARTA, prior chemo allowed<strong>&#8211; <\/strong>Part C: Abi + ADT 8 day lead-in then add ARV-766 (AR PROTAC) <\/span><br \/>\n<span style=\"color: #808080;\">Estimated Study Completion Date: June 27, 2025<\/span><br \/>\n<span style=\"color: #808080;\">ClinicalTrials.gov Identifier: <a style=\"color: #808080;\" href=\"https:\/\/clinicaltrials.gov\/show\/NCT05067140\" target=\"_blank\" rel=\"noopener\">NCT05067140<\/a><\/span><\/p>\n<hr>\n<h2><span style=\"text-decoration: underline;\">CRPC<\/span><\/h2>\n<p data-fontsize=\"23\" data-lineheight=\"23\"><span style=\"color: #808080;\"><b><span style=\"text-decoration: underline;\">c2321001<\/span>: <\/b>A Phase 1 Dose Escalation and Expanded Cohort Study Of PF-06821497 In The Treatment Of Adult Patients With Relapsed\/Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) And Follicular Lymphoma (FL)<\/span><\/p>\n<p><span style=\"color: #808080;\">Phase: 1<\/span><br \/>\n<span style=\"color: #808080;\">Study Product: CRPC \u00b1 mets<strong>, <\/strong>post Abi and\/or Enza<em>&#8211; <\/em><span style=\"text-decoration: underline;\">part 1C EZH2i alone<\/span><span style=\"text-decoration: underline;\">; part 2A EZH2i + Enza<\/span><\/span><br \/>\n<span style=\"color: #808080;\">Estimated Study Completion Date: October 24, 2025<\/span><br \/>\n<span style=\"color: #808080;\">ClinicalTrials.gov Identifier: <a style=\"color: #808080;\" href=\"https:\/\/clinicaltrials.gov\/show\/NCT03460977\" target=\"_blank\" rel=\"noopener\">NCT03460977<\/a><\/span><\/p>\n<hr>\n<h2 id=\"psa_relapse\"><strong><u style=\"font-size: 28px; font-weight: 600;\">mCRPC<\/u><\/strong><\/h2>\n<\/div>\n<p><strong><em><span style=\"color: #808080;\">Treatment Na\u00efve<\/span> <\/em><\/strong><\/p>\n<p data-fontsize=\"23\" data-lineheight=\"23\"><span style=\"color: #808080;\"><strong><span style=\"text-decoration: underline;\">ESSA<\/span>: <\/strong>A Phase 1\/2 Study of EPI-7386 in Combination With Enzalutamide Compared With Enzalutamide Alone in Subjects With Metastatic Castration-Resistant Prostate Cancer<\/span><\/p>\n<p data-fontsize=\"20\" data-lineheight=\"24\"><span style=\"color: #808080;\">Phase: 1\/2<\/span><br \/>\n<span style=\"color: #808080;\">Study Product: no prior ARTA- Masofaniten (aniten) + Enza vs Enza alone&nbsp;<\/span><br \/>\n<span style=\"color: #808080;\">Estimated Study Completion Date: January 2026<\/span><br \/>\n<span style=\"color: #808080;\">ClinicalTrials.gov Identifier:&nbsp;<a style=\"color: #808080;\" href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT05075577?term=prl-02-1001&amp;draw=2&amp;rank=1\" target=\"_blank\" rel=\"noopener\">NCT05075577<\/a><\/span><\/p>\n<hr>\n<div id=\"psa_relapse\">\n<p><span style=\"color: #808080;\"><strong><em>Post Abi, Enza, Apa, and\/or Daro in mCSPC or mCRPC setting (prior chemo allowed)<\/em><\/strong><\/span><\/p>\n<p data-fontsize=\"23\" data-lineheight=\"23\"><span style=\"color: #808080;\"><strong><span style=\"text-decoration: underline;\">Propella<\/span>: <\/strong>Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients with Advanced Prostate Cancer<\/span><\/p>\n<p data-fontsize=\"20\" data-lineheight=\"24\"><span style=\"color: #808080;\">Phase: 1<\/span><br \/>\n<span style=\"color: #808080;\">Study Product: <strong>&nbsp;<\/strong>post Abi and\/or Enza (4wk washout)- must have ADT \u22651 month and T 2-49 ng\/dL- IM Abi depot + Pred <\/span><br \/>\n<span style=\"color: #808080;\">Estimated Study Completion Date: April 30, 2025<\/span><br \/>\n<span style=\"color: #808080;\">ClinicalTrials.gov Identifier:&nbsp;<a style=\"color: #808080;\" href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT04729114?term=prl-02-1001&amp;draw=2&amp;rank=1\" target=\"_blank\" rel=\"noopener\">NCT04729114<\/a><\/span><\/p>\n<hr>\n<p data-fontsize=\"23\" data-lineheight=\"23\"><span style=\"color: #808080;\"><b><span style=\"text-decoration: underline;\">ARV-766 with AR-LBD<\/span>: <\/b>A Phase 1\/2 Open-Label, Dose-Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-766 in Patients with Metastatic Castration-Resistant Prostate Cancer<\/span><\/p>\n<p><span style=\"color: #808080;\">Phase: 1\/2<\/span><br \/>\n<span style=\"color: #808080;\">Study Product: post 1-3 ARTA for mCSPC or mCRPC (2 lines chemo allowed)- Part B phase 2 dose expansion: oral ARV-766 (AR PROTAC)- must have AR-LBD mutation&nbsp;<\/span><br \/>\n<span style=\"color: #808080;\">Estimated Study Completion Date: June 27, 2025<\/span><br \/>\n<span style=\"color: #808080;\">ClinicalTrials.gov Identifier: <a style=\"color: #808080;\" href=\"https:\/\/clinicaltrials.gov\/show\/NCT05067140\" target=\"_blank\" rel=\"noopener\">NCT05067140<\/a><\/span><\/p>\n<\/div>\n<div id=\"mcrpc\">\n<hr>\n<p data-fontsize=\"23\" data-lineheight=\"23\"><em style=\"color: #808080;\"><strong>Post Doce<\/strong><\/em><\/p>\n<\/div>\n<p data-fontsize=\"23\" data-lineheight=\"23\"><span style=\"color: #808080;\"><strong><span style=\"text-decoration: underline;\">MK365<\/span>: <\/strong> Phase Ib\/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)<\/span><\/p>\n<p><span style=\"color: #808080;\">Phase: 1b\/2<\/span><br \/>\n<span style=\"color: #808080;\">Study Product: Cohort E: Pembro + Lenvatinib; Cohort F: t-NE-Pembro + Lenvatinib; Cohort G: Pembro + Vibostolimab; Cohort H: t-NE-Pembro + Vibostolimab<\/span><br \/>\n<span style=\"color: #808080;\">Estimated Study Completion Date: May 30, 2025<\/span><br \/>\n<span style=\"color: #808080;\">ClinicalTrials.gov Identifier:&nbsp;<a style=\"color: #808080;\" href=\"https:\/\/clinicaltrials.gov\/show\/NCT02861573\" target=\"_blank\" rel=\"noopener\">NCT02861573<\/a><\/span><\/p>\n<hr>\n<p><span style=\"color: #808080;\">Disclaimer: We update this information regularly. However, what you read today may not be completely up to date. Please remember to talk to your healthcare providers first before making decisions about your plan of care.<\/span><\/p>\n<p><strong><span style=\"color: #808080;\">Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study. To learn more about our trials, call Jennifer at (843) 449-1010 ext. 316 or email us by filling out the form below.<\/span><br \/>\n<\/strong><\/p>\n<\/div><\/section><\/div><\/div><\/div><\/main><!-- close content main element --><\/div><\/div><div id='after_section_1'  class='main_color av_default_container_wrap container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-1112'><div class='entry-content-wrapper clearfix'><section  class='av_textblock_section av-78nko-d346ea5038bf6afd596f5d66989a56f6 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><h3><span style=\"color: #18629b;\">Please fill in the form below to email us to learn more about our trials:<\/span><\/h3>\n<script type=\"text\/javascript\">var 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