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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

2. september 2026 opdateret af: Blue Earth Diagnostics

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

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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)

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

142

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • San Diego, California, Forenede Stater, 92103
        • Ikke rekrutterer endnu
        • University of California San Diego Health
        • Kontakt:
          • Sherief H Gamie, MD
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Ikke rekrutterer endnu
        • Emory University
        • Kontakt:
          • Ismaheel Lawal, MD
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Ikke rekrutterer endnu
        • Massachusetts General Hospital
        • Kontakt:
          • Pedram Heidari, MD
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Ikke rekrutterer endnu
        • Washington University
        • Kontakt:
          • Ashwin Parihar, MD
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Rekruttering
        • Oregon Health & Science University
        • Kontakt:
          • Nadine Mallak, MD
    • Texas
      • Austin, Texas, Forenede Stater, 78759
        • Ikke rekrutterer endnu
        • Urology Austin
        • Kontakt:
          • Brian Mazzarella, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Participants must be males aged ≥18 years at Screening.
  2. 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.
  3. 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.
  4. 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.
  5. Participants must provide written informed consent before any study-specific procedures or interventions are performed.
  6. Ability of the participants to comply with planned study procedures

Exclusion Criteria:

  1. Participants with known metastatic castrate resistant prostate cancer.
  2. 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.
  3. 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.
  4. 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.
  5. Participants with known hypersensitivity to the active substance or to any of the excipients of fluciclovine (18F).
  6. Participants who have received salvage therapy for the current episode of BCR.
  7. 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Patients Single intravenous administration of fluciclovine (18F) for PET Scan
Medicin: fluciclovine (18F)
fluciclovine (18F) injection, 370 MBq (10 mCi) ± 20%, delivered as an intravenous bolus.
Andre navne:
  • Axumin

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tidsramme
For those participants with a CIM, summary of the CIM groups following a fluciclovine (18F) PET/CT scan.
Tidsramme: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
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.
Tidsramme: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
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.
Tidsramme: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
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
Tidsramme: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
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
Tidsramme: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
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
Tidsramme: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
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.
Tidsramme: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Blue Earth Diagnostics

Efterforskere

  • Ledende efterforsker: Nadine Mallak, MD, Oregon Health and Science University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. august 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2032

Datoer for studieregistrering

Først indsendt

22. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BED-FLC-401

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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