Evaluating Fluciclovine PET in Patients With Biochemical Recurrence of Prostate Cancer and a Negative PSMA PET

Clinicaltrials.gov ID: NCT05722925
db-list-check Status RECRUITING
b-loader Phase PHASE4
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 50

Conditions

Prostate Cancer

Drugs

Fluciclovine PET/CT

Summary

The purpose of this prospective cohort study is to investigate the role of Fluciclovine Positron Emission Tomography (PET) in patients with biochemical recurrence of prostate cancer (BCR) and a negative Prostate Specific Membrane Antigen (PSMA) PET, specifically, whether Fluciclovine PET can help detect local recurrence and whether the results of Fluciclovine PET can change management.

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the detection rate of local recurrence of prostate cancer on Fluciclovine PET in patients with BCR and a negative or equivocal PSMA PET obtained within 30 days prior to the Fluciclovine PET.

SECONDARY OBJECTIVES:

I. To evaluate the correct localization rate of Fluciclovine PET in patients with positive scans.

II. To distinguish the detection rate by site of recurrence (local recurrence in the prostate bed, lymph node involvement, or distant metastatic disease), and stratify by PSA level at the time of the scan and tumor grade

III. To evaluate the change in management based on the results of Fluciclovine PET, relative to intended management based on the result of negative PSMA PET alone, prior to obtaining the Fluciclovine PET.

OUTLINE:

Patients will be imaged with Fluciclovine PET within 30 days of the negative or equivocal PSMA scan.

A short questionnaire inquiring about the intended management will be sent to the referring physician at two timepoints: 1) the first is at the time of screening, prior to the Fluciclovine PET; and 2) the second is after the availability of the results of Fluciclovine PET.

Change in intended management will be recorded. Participants will be followed for 6 months and will be managed by their treating physician as per standard-of-care.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Nadine Mallak, M.D.

Eligibility Criteria

Inclusion Criteria:

* Age >= 18 years.
* Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed.
* Patients with suspected BCR of prostate cancer after initial treatment, and a negative or equivocal PSMA PET, regardless of the findings on conventional imaging. Initial treatment may include prostatectomy and/or radiation therapy.
* PSA of 0.2 ng/mL or higher within 45 days of the scan.

Exclusion Criteria:

* Uncontrolled serious infection.
* Intercurrent illness or condition that would limit compliance with study requirements.
* Patients who have started any cancer treatment (systemic or radiation therapy) or who have started any supplements or herbal medications intended to treat cancer between the PSMA PET and Axumin PET/CT scans.

Study Plan

Fluciclovine PET/CT

EXPERIMENTAL

Participants will undergo Fluciclovine PET/CT within 30 days of a negative or equivocal PSMA PET scan. After the Fluciclovine PET/CT, the patient will follow up with their treating physician as per standard-of-care. The research team will collect clinical and imaging data at 6 months post Fluciclovine-PET/CT.

  • DRUG:

    Fluciclovine PET/CT

    Description:

    8 mCi (u00b1 20%) of Fluciclovine administered as a bolus intravenous injection

Outcome Measures

Primary Outcome Measures

Number of participants with BCR and a positive Fluciclovine PET performed within 30 days after a negative or equivocal PSMA PET

Time Frame: During PET scan procedure

Secondary Outcome Measures

Correct localization rate (CLR) of Fluciclovine PET in patients with positive scans.

Time Frame: During PET scan procedure

Number of participants with positive Fluciclovine PET summarized by site of recurrence (local recurrence in the prostate bed, lymph node involvement, or distant metastatic disease), stratified by PSA level

Time Frame: During PET scan procedure

Change in management based on the results of Fluciclovine PET, relative to intended management based on the result of negative PSMA PET alone, prior to obtaining the Fluciclovine PET.

Time Frame: Enrollment up to 1 month after scan

Timeline

  • Last Updated
    July 5, 2024
  • Start Date
    February 10, 2023
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    January 1, 2026

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