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Trial Title:
Evaluating Fluciclovine PET in Patients With Biochemical Recurrence of Prostate Cancer and a Negative PSMA PET
NCT ID:
NCT05722925
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Recurrence
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fluciclovine PET/CT
Description:
8 mCi (± 20%) of Fluciclovine administered as a bolus intravenous injection
Arm group label:
Fluciclovine PET/CT
Other name:
18F-FACBC
Other name:
Axumin®
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.
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Oregon Health & Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
OHSU Diagnostic Radiology Research
Phone:
503-494-5157
Email:
RADResearch@ohsu.edu
Investigator:
Last name:
Nadine Mallak, M.D.
Email:
Principal Investigator
Start date:
October 4, 2023
Completion date:
January 1, 2026
Lead sponsor:
Agency:
OHSU Knight Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Blue Earth Diagnostics
Agency class:
Industry
Collaborator:
Agency:
Oregon Health and Science University
Agency class:
Other
Source:
OHSU Knight Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05722925
