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Not yet recruiting NCT07569926

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

Phase IV Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fluciclovine (18F).
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Detailed description

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)

Interventions

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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 6 centers
  • 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

Identifiers

NCT: NCT07569926 · BED-FLC-401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗