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Идёт набор NCT06859203

A Prospective, Bicentric Evaluation of Fluciclovine PET-imaging in Patients with Prior Negative or Inconclusive PSMA-ligand PET

— Наблюдательное Biochemical Recurrence of Malignant Neoplasm of Prostate

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Biochemical Recurrence of Malignant Neoplasm of Prostate. 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
Германия
Следующий шаг
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Официальное название

Prospective Evaluation of Fluciclovine (18F) PET/CT in Patients with Prior Negative PSMA PET/CT

Обзор

The REFINE study is evaluating whether a fluciclovine (18F) PET/CT scan can detect recurrent prostate cancer in patients whose previous PSMA PET/CT was negative or inconclusive.

Подробное описание

The REFINE study is a prospective, bicentric observational trial conducted at two specialized nuclear medicine centers in Germany to evaluate the technical performance of fluciclovine (18F) PET/CT imaging in a real-world clinical setting. Patients with prostate cancer recurrence after definitive treatment who previously underwent a negative or inconclusive PSMA PET/CT are enrolled and observed for 12 months. Each participant undergoes a fluciclovine PET/CT scan as part of their normal clinical routine, with all images pseudonymized and stored in a central database where three independent nuclear medicine physicians, blinded to the local site's interpretation, review each scan. In addition to the initial imaging, follow-up assessments are conducted at one month and 12 months to validate scan findings; a questionnaire sent to the referring physician at one month helps capture any changes in the intended treatment plan, while comprehensive follow-up data-including additional imaging studies, PSA levels, treatment outcomes, and histopathological findings when available-are collected at 12 months. This follow-up information serves as a composite reference standard to distinguish true positive lesions from false positives, with criteria based on changes in lesion size, response to treatment, and confirmatory imaging or biopsy results, as well as to identify any false negatives.

Первичные конечные точки

  • Patient-level detection rate [Срок оценки: From enrollment to the end of observation at 1 year]
Вторичные конечные точки (4)
  • Region level detection rate [Срок оценки: From enrollment to the end of observation at 1 year]
  • Detection rate stratified by PSA level [Срок оценки: From enrollment to the end of observation at 1 year]
  • Intended management change [Срок оценки: From enrollment to the end of observation at 1 year]
  • Interreader agreement [Срок оценки: From enrollment to the end of observation at 1 year]

Критерии участия

Критерии включения

  • Patient is male and aged >18 years old.
  • Patient with a history of localized adenocarcinoma of the prostate with prior curative intent treatment, experiencing BCR of hormone sensitive PCa, following prior treatment with one or more of the following: a) RP, b) RP plus adjuvant therapy, c) RT and/or androgen deprivation therapy \[ADT\].
  • An elevated PSA, clinically suspicious for biochemically recurrent disease, that meets one of the following conditions: 1) Following RP with or without adjuvant therapy: PSA ≥0.2 ng/mL followed by a subsequent confirmatory PSA value ≥0.2 ng/mL and within the total range of 0.2 and 2 ng/ml. PSA must be measured at least 6 weeks after RP. 2) Following RT (e.g. radical radiotherapy or brachytherapy) as the primary treatment: nadir +2 ng/mL and within the total range of 2 and 4 ng/ml

Критерии исключения

  • Patients with any medical condition or circumstance (including receiving an investigational product) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.
  • Current or recent androgen deprivation therapy (ADT) within 3 months prior to the start of the study, which includes surgical orchidectomy, continuous or intermittent LHRH agonist/antagonist, and first-/second-generation anti androgen alone or combined with LHRH agonist/antagonist.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Германия · 2 центра
  • University Hospital Augsburg — Augsburg
  • TUM University Hospital — Munich

Идентификаторы

NCT: NCT06859203 · 2024-643-S-NP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗