The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer

Официальное название

Molecular Phenotyping and Image-Guided Surgical Treatment of Prostate Cancer Using Ultrasmall Silica Nanoparticles

Обзор

The purpose of this study is to see whether using the copper-64 (64Cu) or zirconium-89 (89Zr) radiolabeled PSMA-targeting C' dot tracer, termed 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots or 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots, is a safe way to identify tumor cells before and during surgery for prostate cancer. The researchers want to determine whether pre-operative PET/MRI scans and intra-operative optical imaging performed in prostate cancer patients after the injection of one of these investigational tracers more accurately localizes cancerous deposits within the surgical bed as compared with conventional imaging scans alone. The researchers will study how the tracer travels through your body and where it is distributed. This study is the first time that the tracer will be used in patients undergoing surgery for prostate cancer.

Вмешательства

• Препарат (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer
  Patients will be injected with approximately 6-7 mCi (+/- 10%) of 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots
• Диагностический тест PET/MRI/fluorescence imaging
  Imaging will be performed using the GE Signa PET/MRI.
• Другое Blood and urine sampling
  Staff will perform the IV blood draws and collect urine samples
• Процедура laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection
  Surgery will be performed within 24 h of the third PET/MRI scan.
• Препарат 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots
  Patients (up to 6) will receive an intravenous (IV) injection of approximately 5-7 mCi (+/- 10%) of PSMA-targeting C' dot tracer within 24-48 h before surgery. Patients will then undergo one preoperative PET/MR imaging

Первичные конечные точки

• Side effects [Срок оценки: 1 year]

Критерии участия

Критерии включения

Primary RP + PLND

• Age ≥18 years
• Patients meeting one of the following criteria:

• Tumor clinical stage T3a or higher
• Gleason score 8-10, or
• PSA level > 20 ng/mL
• Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion
• Patient is scheduled for standard of care laparoscopic radical prostatectomy (with or without robotic assistance)

Salvage PLND

• Age ≥18 years
• Patients with presence of suspicious lymph node on CT or MRI (of a pelvic node => 10mm in short axis or a node with abnormal morphology such as roundness irregularity or loss of fatty hilum, or PSMA-avid on PSMA PET imaging
• Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion
• Patient is scheduled for standard of care salvage pelvic lymph node dissection (with or without robotic assistance)

Критерии исключения

• Contraindications to standard-of-care MR imaging (e.g., metal implants, claustrophobia)
• Prior androgen-deprivation therapy for prostate cancer (N/A for Salvage PLND)
• Prior pelvic radiotherapy (N/A for Salvage PLND )
• Medical illness unrelated to the tumor that, in the opinion of the attending physician and principal investigator, will preclude administration of the tracer

°This includes patients with uncontrolled infection, chronic renal insufficiency (EGFR < 60 mL/min/1.73m2), myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease

• Weight greater than the 400-lb weight limit of the PET scanner
• Unmanageable claustrophobia
• Inability to lie in the scanner for 30 min

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

Диагностика

Центры проведения

США · 2 центра

• Memorial Sloan Kettering Cancer Center — New York
• Weill Cornell Medicine — New York

Идентификаторы

NCT: NCT04167969 · 19-333

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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