PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer

Официальное название

2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-Amino]-Pentyl}-Ureido)-Pentanedioic Acid (PyL) in Patients With High Risk and Biochemically Recurrent Prostate Cancer

Обзор

The standard of care imaging of prostate cancer metastases recommended by the National Comprehensive Cancer Network (NCCN), CT of the chest/abdomen/pelvis and bone scan, may be suboptimal. PyL is a novel PET tracer designed to detect prostate specific membrane antigen (PSMA) expressed on prostate cancer cells. PyL PET/CT may provide improved evaluation of clinically significant metastases in patients with prostate cancer.

Подробное описание

This will be a phase II clinical trial to assess the clinical value of PyL for detection of disease in pateints with:

1. High risk prostate cancer and planned prostatectomy or radiation therapy (arm 1) and 2. Biochemically recurrent prostate cancer (arm 2) but without evidence of disease of standard of care imaging (CT of the chest/abdomen/pelvis and bone scan).

In both cohorts, PyL PET/CT will be obtained and evaluated by a nuclear radiologist trained in novel PET radiotracers, including PyL. Lesions suspicious for disease of PyL that were unsuspected on standard of care imaging will be selected for biopsy for pathologic confirmation if feasible . Pathology will be used as the reference standard for confirming malignancy.

Вмешательства

• Препарат DCFPyL PET/CT
  Prostate Membrane Specific Antigen-specific imaging

Первичные конечные точки

• Detection of unsuspected metastases in high risk prostate cancer [Срок оценки: up to 4 weeks]
• Detection of unsuspected metastases in biochemically recurrent prostate cancer [Срок оценки: up to 4 weeks]

Критерии участия

Критерии включения

• Male ≥ 18 years of age.
• Histologically confirmed adenocarcinoma of the prostate
• Patients meet one of the follow criteria:

Cohort 1: High risk prostate cancer (PSA >10, Gleason 8-10, or clinical stage >T2c) and planned prostatectomy or radiation therapy or Cohort 2: Biochemical prostate cancer relapse (Prostate Specific Antigen (PSA) > 0.2 ng/ml in patients following prostatectomy or ≥ 2 ng/ml more than the PSA nadir in patient following radiotherapy, as defined by the ASTRO-Phoenix criteria \[18\] and no evidence of malignancy on standard of care imaging for metastases (CT of the chest/abdomen/pelvis and bone scan) within 3 months.

Критерии исключения

• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
• Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
• Change in therapy since standard of care imaging

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Hoag Memorial Hospital Presbyterian — Irvine

Публикации

• Ulaner GA, Thomsen B, Bassett J, Torrey R, Cox C, Lin K, Patel T, Techasith T, Mauguen A, Rowe SP, Lindenberg L, Mena E, Choyke P, Yoshida J. 18F-DCFPyL PET/CT for Initially Diagnosed and Biochemically Recurrent Prostate Cancer: Prospective Trial with Pathologic Confirmation. Radiology. 2022 Nov;305(2):419-428. doi: 10.1148/radiol.220218. Epub 2022 Jul 19. PMID 35852431

Идентификаторы

NCT: NCT04700332 · 184-20-CA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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