Actively Recruiting
Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT
Led by Brigham and Women's Hospital · Updated on 2025-11-05
30
Participants Needed
2
Research Sites
239 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
B
Blue Earth Diagnostics
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of advanced prostate cancer that either has low prostate-specific membrane antigen (PSMA) expression or has neuroendocrine features. The name of the study interventions are: * 18F-fluciclovine-PET/CT scan * Two research blood collections
CONDITIONS
Official Title
Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic prostate cancer with either castration resistant PSMA-low disease defined by whole-body SUVmean 6#8804; 10 on 68Ga-PSMA-11 PET/CT and at least 5 metastatic lesions, or neuroendocrine prostate cancer pathology based on tumor biopsy
- At least 5 metastatic lesions present
- Have had or are planned to have a standard 68Ga-PSMA PET/CT scan before or after 18F-fluciclovine-PET/CT
- Age 18 years or older
- ECOG performance status 0, 1, or 2
- Ability and willingness to comply with study procedures
- Male participants agree to use adequate contraception or abstinence prior to and for 24 hours after PET/CT scan
- Ability to understand and sign informed consent
You will not qualify if you...
- Other known cancers requiring treatment
- History of allergic reactions to compounds similar to 18F-fluciclovine
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting study compliance
- Contraindications to PET/CT scanning including severe claustrophobia
- Any condition that could affect study results or increase risk as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
H
Heather Jacene, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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