Impact of Fluciclovine (18F) PET (Positron Emission Tomography) on the Management of Prostate Cancer Following Negative or Equivocal PSMA (Prostate-Specific Membrane Antigen) PET Imaging at the Time of Biochemical Recurrence

Официальное название

The Impact of Fluciclovine (18F) PET on the Management of Participants With Prostate Cancer Following Negative or Equivocal PSMA PET Imaging at the Time of Biochemical Recurrence

Обзор

The impact of fluciclovine (18F) PET on the management of participants with prostate cancer following negative or equivocal PSMA PET Imaging at the time of biochemical recurrence

Подробное описание

This is a prospective, multi-institutional, Phase 4 study to assess change in management (CIM) following fluciclovine (18F) imaging in participants with prostate cancer who have a negative or equivocal prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan at the time of any biochemical recurrence (BCR)

Вмешательства

• Препарат fluciclovine (18F)
  fluciclovine (18F) injection, 370 MBq (10 mCi) ± 20%, delivered as an intravenous bolus.

Первичные конечные точки

• Percentage of participants with any recorded Change In Management following a fluciclovine (18F) PET/CT scan. [Срок оценки: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days]

Вторичные конечные точки (7)

• For those participants with a change in management (CIM), percentage of participants with a recorded minor or major CIM following a fluciclovine (18F) PET/CT scan. [Срок оценки: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days]
• For those participants with a CIM, summary of the CIM groups following a fluciclovine (18F) PET/CT scan. [Срок оценки: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days]
• Participant-level and region-level (prostate bed, pelvic lymph nodes [PLNs], other) detection rates. [Срок оценки: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days]
• Participant-level and region-level (prostate bed, PLNs, other) detection rates stratified by PSA levels. [Срок оценки: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days]
• Percentage of participants with any recorded CIM following a positive/negative fluciclovine (18F) PET/CT [Срок оценки: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days]
• Percentage of participants with a recorded minor or major CIM following a positive/negative fluciclovine (18F) PET/CT [Срок оценки: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days]
• For those participants with a CIM, summary of CIM groups following a positive/negative fluciclovine (18F) PET/CT [Срок оценки: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days]

Критерии участия

Критерии включения

• Participants must be males aged ≥18 years at Screening.
• Participants with suspected BCR of prostate cancer (see Inclusion Criterion #3 below) following prior curative intent treatment and a negative or equivocal PSMA PET scan with any FDA-approved PSMA PET tracer (must be within 45 days prior to Visit 2 \[fluciclovine (18F) PET/CT scan\]), regardless of findings on conventional imaging.
• Participants suspicious for a biochemically recurrent prostate cancer with a detectable or rising PSA after definitive therapy on the basis of: Post-radical prostatectomy (with or without adjuvant or salvage radiation therapy): PSA that is ≥0.2 ng/mL (completed >6 weeks after surgery) or Post-radiation therapy (with or without ADT): Increase in PSA level that is ≥2.0 ng/mL above the nadir PSA level and rising PSA is confirmed on consecutive PSA determinations.
• Men who are sexually active with women of childbearing potential (WOCBP), must agree to use a highly effective method(s) of contraception for 24 hours post-fluciclovine (18F) injection.
• Participants must provide written informed consent before any study-specific procedures or interventions are performed.
• Ability of the participants to comply with planned study procedures

Критерии исключения

• Participants with known metastatic castrate resistant prostate cancer.
• Participants with any medical condition (including intercurrent illness and uncontrolled serious infection) or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to comply with the study requirements.
• Participants who are planned to have an x-ray contrast agent or any other PET radiotracer within five physical half-lives of the first PET radionuclide prior to the study fluciclovine (18F) PET/CT scan.
• Participants participating in an interventional clinical trial within 30 days and having received an IP five physical half-lives prior to the study fluciclovine (18F) PET/CT scan.
• Participants with known hypersensitivity to the active substance or to any of the excipients of fluciclovine (18F).
• Participants who have received salvage therapy for the current episode of BCR.
• Participants who initiate cancer treatment (systemic or radiation therapy) or who have started any supplements or herbal medications intended to treat cancer between the PSMA PET and fluciclovine (18F) PET/CT scans.

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 · 6 центров

• University of California San Diego Health — San Diego
• Emory University — Atlanta
• Massachusetts General Hospital — Boston
• Washington University — St Louis
• Oregon Health & Science University — Portland
• Urology Austin — Austin

Идентификаторы

NCT: NCT07569926 · BED-FLC-401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗