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Набор скоро начнётся NCT07593079

Prostate Specific Membrane Antigen (PSMA) Imaging for Detection of Residual and Metastatic Prostate Cancer

Фаза II С лечением Prostate Cancer Recurrent Prostate Cancer Metastatic Prostate Cancer Prostate Cancer Recurrent

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Bicalutamide, Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography, 18F-rhPSMA-7.3, PROSTest.
Кому может быть актуально
Состояния в реестре: Prostate Cancer, Recurrent Prostate Cancer, Metastatic Prostate Cancer, Prostate Cancer Recurrent. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Optimizing PSMA Imaging for Enhanced Detection of Residual and Metastatic Prostate Cancer in Low PSA Recurrence (OPERA) Study

Обзор

This is a randomized, open-label, pilot study assessing the impact of a short course of bicalutamide on PSMA expression in patients with prostate cancer belonging to the intermediate unfavorable or high risk group, who have low levels of PSA. Adult patients with biochemically recurrent prostate cancer (BCR PCa) who have a PSA of less than 1.0 ng/mL and who have undergone complete prostatectomy and/or will be undergoing radiotherapy, in combination with standard of care bicalutamide, will be recruited to this study. Patients will be randomized in a 1:1 ratio into Group A (baseline PSMA PET/CT only with bicalutamide standard of care) or Group B (baseline PSMA PET/CT and an additional PSMA PET/CT after 2 weeks of bicalutamide).

Вмешательства

  • Препарат Bicalutamide
    Bicalutamide is a non-steroidal androgen receptor inhibitor administered as a once a day pill taken orally. This is given as standard of care.
  • Устройство Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography
    Patients will undergo prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography (PSMA PET-CT) imaging. Each PSMA PET-CT session will consist of 5 minutes of dynamic imaging conducted via the Biograph Vision Quadra PET-CT, a whole-body PET-CT scanner.
  • Препарат 18F-rhPSMA-7.3
    Radioactive diagnostic agent for intravenous use.
  • Диагностический тест PROSTest
    PROSTest is a novel, blood-based qPCR assay that assesses gene expression to diagnose PCa and predict patient outcomes to different treatments.

Первичные конечные точки

  • Group B only: Lesion detection rates between PET1 and PET2. [Срок оценки: Baseline and 14 days after start of bicalutamide treatment (total estimated time 14 days)]
Вторичные конечные точки (5)
  • Group A and B: Number of lesions detected on early scan versus delayed scan [Срок оценки: At baseline and 14 days after start of bicalutamid treatment (total estimated time is 14 days)]
  • Group A and B: Correlation between PSA response and PROSTest after radiation therapy [Срок оценки: Through day 90]
  • Group A and B: Comparison of PSA response in patients who are treated with radiation vs. those treated with radiation [Срок оценки: Through day 90]
  • Group B only: Correlation between PSA kinetics and detection rates between PET1 and PET2 [Срок оценки: Through day 90]
  • Group B only: Correlation between PROSTest results and detection rates of PET1 and PET2 [Срок оценки: 14 days after start of bicalutamide treatment (total estimated time 14 days)]

Критерии участия

Критерии включения

  • Histologically or cytologically confirmed biochemically recurrent prostate cancer, with original diagnosis no more than 2 years from date of consent.
  • Intermediate unfavorable or high-risk prostate cancer.
  • All patients under consideration for radiation therapy, either at the time of first recurrence or in salvage radiation therapy will be included.
  • Patients who have started bicalutamide up to a maximum of 3 days prior to randomization will be allowed to be on protocol. Otherwise, a washout period of at least 42 days will be required.
  • Biological males, at least 18 years of age.
  • Prostate specific antigen (PSA) < 1.0 ng/mL.
  • Agreement to adhere to Lifestyle Considerations throughout study duration
  • Ability to understand and willingness to sign an IRB approved written informed consent document.

Критерии исключения

  • Patients currently on androgen deprivation therapy (ADTs).
  • Currently receiving any other investigational agents.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to POSLUMA, furosemide, bicalutamide, or other agents used in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 1 центр
  • Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT07593079 · 202604224

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗