XCancer
Blue Earth Diagnostics, LTD

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

Description:

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

Sponsor:

Blue Earth Diagnostics, LTD

Phase:

Phase 4

Contacts:

BED-Flc-401 Study Team (CONTACT)

bed-flc-401_study@bracco.com

+44 (0) 1865 507300

Nadine Mallak, MD (PRINCIPAL_INVESTIGATOR)

Government Study Link:

NCT07569926 - Click here to see study on

ClinicalTrials.gov

fluciclovine

Isotope(s):
Target(s):
  • Amino Acid Transport
Ligand Class: Small Molecules
Inclusion
  • 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.
  • 1. Participants must be males aged ≥18 years at Screening.
  • 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 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 must provide written informed consent before any study-specific procedures or interventions are performed.
Exclusion
  • 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 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 with known hypersensitivity to the active substance or to any of the excipients of fluciclovine (18F).
  • 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.
  • 1. Participants with known metastatic castrate resistant prostate cancer.

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