[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07725523":3,"trial-entities:NCT07725523":105,"trial-summary:NCT07725523":110},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":30,"interventions":33,"primary_outcomes":39,"secondary_outcomes":44,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":66,"locations":69,"central_contacts":98,"overall_officials":100,"references":103,"see_also_links":104},"NCT07725523","UROL-CC-IUSCCC-0965","Safety and Efficacy of OTL78 (Zopocianine)","Safety and Efficacy of OTL78 (Zopocianine), a Prostate-Specific Membrane Antigen (PSMA)-Targeted Fluorescent Agent, for Intraoperative Imaging of Prostate Cancer: A Phase IIb Trial","NOT_YET_RECRUITING","2027-04","2026-07","2026-07-30","2026-09","Clinton Bahler","OTHER",true,"This study is being done to support the selection of single dose and timing regimen of Zopocianine (OTL78) in combination with Near InfraRed (NIR) fluorescent imaging to improve the detection of malignant (growing in an uncontrolled way) tissue in adult patients undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.","Prostate cancer (PCa) is the second leading cause of cancer-related death behind lung cancer. Prostate cells express Prostate Specific Membrane Antigen (PSMA), which is overexpressed in PCa cells in over 90% of patients. On Target has developed a PSMA-targeted agent, the drug product OTL78, that fluoresces under NIR illumination to help with the identification of prostate cancer tissue during resection surgery that has extended beyond the capsule of the prostate into adjacent tissue and lymph nodes. Intra-operative identification of cancer tissue using real-time imaging modalities that could improve tumor identification, demarcation and lymph node involvement may provide a very useful tool to reduce the frequency of residual cancer and increase complete removal of locally involved lymph nodes.\n\nThis study is an open label trial of an imaging agent, PSMA targeted fluorescent dye (zopocianine, OTL78), in up to 32 participants with biopsy confirmed PCa who have been scheduled to undergo a laparoscopic radical prostatectomy with pelvic lymph node dissection in order to confirm the optimal dose and administration-to-surgery interval of the drug in visualizing cancerous tissue during a standard of care radical prostatectomy.",[19,20],"Prostate Cancer Surgery","Prostate Cancer Metastatic Disease",[22,23,24],"Prostate Specific Membrane Antigen","Fluorescent Imaging","Near infrared imaging","INTERVENTIONAL","TREATMENT",[28,29],"PHASE2","PHASE3",{"count":31,"type":32},36,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","0.06mg\u002Fkg ZOPOCIANINE given 1-7 days prior to surgery","A single dose of 0.06mg\u002Fkg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection",[36],[40],{"measure":41,"description":42,"timeFrame":43},"Proportion of subjects who have a Clinically Significant Event","a) Histologically confirmed cancer in residual non-nodal soft tissue resected solely because of \"NIR only\" detection as suspicious following prostatectomy. b) One or more resected NIR- positive lymph nodes that contain metastatic disease as confirmed by pathology.","Day of surgery",[45,48,51,54],{"measure":46,"description":47,"timeFrame":43},"Detection of Primary cancer","For primary cancer, the number of lesions that are either: fluorescence positive, and prostate cancer positive (i.e., true positive); fluorescence positive but cancer negative (i.e., false positive); fluorescence negative but cancer positive (i.e., false negative); or, fluorescence negative and cancer negative (i.e., true negative). We will consider disease state at four (4) defined prostate regions - right posterior, left posterior, anterior, and at the bladder neck",{"measure":49,"description":50,"timeFrame":43},"Detection of Metastatic Cancer","For metastatic cancer spread to lymph nodes, the number of lesions that are either: fluorescence positive, and prostate cancer positive (i.e., true positive); fluorescence positive but cancer negative (i.e., false positive); fluorescence negative but cancer positive (i.e., false negative); or, fluorescence negative and cancer negative (i.e., true negative). We will use six (6) defined lymph node regions (external iliac, internal iliac, common iliac and right and left)",{"measure":52,"description":53,"timeFrame":43},"Execution of pre-surgery plan","The pre-surgery plan will be documented and compared to the documented surgery performed if surgeon reports of changes in scope from initial plan.",{"measure":55,"description":56,"timeFrame":57},"Incidence rates AEs and all SAEs","Incidence rates of all causally related AEs and all SAEs","Screening to 6 week follow-up","MALE","18 Years",null,false,{"inclusion":63,"exclusion":64,"raw_text":65},[],[],"Inclusion Criteria:\n\n1. Provision of signed and dated informed consent and HIPAA form\n2. Male participants 18 years of age and older\n3. Known primary prostate cancer and any one of the following:\n\n   1. Grade group 3-5;\n   2. Suspected extra-prostatic extension (EPE) or seminal vesicle invasion (SVI);\n   3. Suspected lymph node metastasis (clinical stage cN1) by magnetic resonance imaging or by Prostate Specific Membrane Antigen positron emission tomography\n4. Planned to undergo a standard of care robotic prostatectomy and lymph node dissection\n5. Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments\n6. Agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including through final study visit (6 weeks) after the dose of study drug. Sperm donation is prohibited during the study and for 3 months after the dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.\n7. Patient scheduled to have or has had a PSMA-PET Scan for surgical treatment planning within 12 months of surgery.\n\nExclusion Criteria:\n\n1. The surgeon plans to perform an extraperitoneal approach\n2. History of anaphylactic reactions to products containing indocyanine green\n3. History of allergy to any of the components of ZOPOCIANINE:\n\n   1. 2-\\[3-(1,3-dicarboxypropyl)ureido\\] pentanedioic acid (DUPA)\n   2. Polyethylene glycol-dipeptide linker\n   3. Chlorodye\n4. Impaired renal or hepatic function:\n\n   1. Renal: creatinine clearance (eGFR) \\\u003C 50 mL\u002Fmin\n   2. Hepatic: total bilirubin \\> 2 × upper limit of normal or ALT\u002FAST \\> 3 × upper limit of normal.\n5. Patients with QTc interval ≥ 470 msec per electrocardiogram (ECG) at screening calculated via the Bazett formula.\n6. Significant acute or chronic medical, neurologic, or illness in the participant that, in the judgment of the Principal Investigator, could compromise participant safety, limit the ability to complete the study, and\u002For compromise the objectives of the study.",[67,68],"ADULT","OLDER_ADULT",[70,88],{"facility":71,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":85},"Indiana University Health North Hospital","Carmel","Indiana","46032","United States",[77,82],{"name":78,"role":79,"phone":80,"email":81},"Brandon Garver","CONTACT","317-278-4766","brwgarve@iu.edu",{"name":83,"role":84},"Clint Bahler, MD","PRINCIPAL_INVESTIGATOR",{"lat":86,"lon":87},39.97837,-86.11804,{"facility":89,"city":90,"state":73,"zip":91,"country":75,"contacts":92,"geoPoint":95},"Indiana University School of Medicine","Indianapolis","46202",[93,94],{"name":78,"role":79,"phone":80,"email":81},{"name":83,"role":84},{"lat":96,"lon":97},39.76838,-86.15804,[99],{"name":78,"role":79,"phone":80,"email":81},[101],{"name":83,"affiliation":102,"role":84},"Indiana University",[],[],{"nct_id":4,"conditions":106,"biomarkers":108},[107],"Prostate Carcinoma",[109],"FOLH1 Gene",{"nct_id":4,"found":15,"summary":111,"prompt_version":121},{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This is a Phase IIb, open-label study involving up to 36 male participants. It is testing a single dose of Zopocianine.","completed","Phase IIb Trial of Zopocianine for Prostate Cancer Surgery","This study is testing a drug called Zopocianine (OTL78) to see how well it helps doctors find prostate cancer during surgery. Zopocianine is given as an injection 1-7 days before surgery. It works with a special camera (Near InfraRed or NIR fluorescent imaging) to make cancer cells glow, which could help surgeons remove all the cancer. The study is looking for men aged 18 and older who have prostate cancer that is more aggressive (Grade group 3-5) or suspected to have spread outside the prostate. The main goal is to see how many patients have a \"Clinically Significant Event\" (meaning cancer was found and removed) on the day of surgery. The current status of the study is unclear.","The primary outcome is measured on the day of surgery.",118,"You would receive a single injection of Zopocianine 1-7 days before your prostatectomy and lymph node dissection surgery.","Not stated in the trial record.",[],"v2"]