Safety and Efficacy of OTL78 (Zopocianine)

Официальное название

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

Обзор

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.

Подробное описание

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.

This 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.

Вмешательства

• Препарат 0.06mg/kg ZOPOCIANINE given 1-7 days prior to surgery
  A single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

Первичные конечные точки

• Proportion of subjects who have a Clinically Significant Event [Срок оценки: Day of surgery]

Вторичные конечные точки (4)

• Detection of Primary cancer [Срок оценки: Day of surgery]
• Detection of Metastatic Cancer [Срок оценки: Day of surgery]
• Execution of pre-surgery plan [Срок оценки: Day of surgery]
• Incidence rates AEs and all SAEs [Срок оценки: Screening to 6 week follow-up]

Критерии участия

Критерии включения

• Provision of signed and dated informed consent and HIPAA form
• Male participants 18 years of age and older
• Known primary prostate cancer and any one of the following:

• Grade group 3-5;
• Suspected extra-prostatic extension (EPE) or seminal vesicle invasion (SVI);
• Suspected lymph node metastasis (clinical stage cN1) by magnetic resonance imaging or by Prostate Specific Membrane Antigen positron emission tomography
• Planned to undergo a standard of care robotic prostatectomy and lymph node dissection
• Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
• 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.
• Patient scheduled to have or has had a PSMA-PET Scan for surgical treatment planning within 12 months of surgery.

Критерии исключения

• The surgeon plans to perform an extraperitoneal approach
• History of anaphylactic reactions to products containing indocyanine green
• History of allergy to any of the components of ZOPOCIANINE:

• 2-\[3-(1,3-dicarboxypropyl)ureido\] pentanedioic acid (DUPA)
• Polyethylene glycol-dipeptide linker
• Chlorodye
• Impaired renal or hepatic function:

• Renal: creatinine clearance (eGFR) < 50 mL/min
• Hepatic: total bilirubin > 2 × upper limit of normal or ALT/AST > 3 × upper limit of normal.
• Patients with QTc interval ≥ 470 msec per electrocardiogram (ECG) at screening calculated via the Bazett formula.
• 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/or compromise the objectives of the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Indiana University Health North Hospital — Carmel
• Indiana University School of Medicine — Indianapolis

Идентификаторы

NCT: NCT07725523 · UROL-CC-IUSCCC-0965

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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