Actively Recruiting
Pilot Study of 18F-fluciclovine PET/CT for Detection of PSMA-Low Castration Resistant and Neuroendocrine Prostate Cancer
Led by Brigham and Women's Hospital · Updated on 2025-11-05
30
Participants Needed
2
Research Sites
104 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
Researchers are studying a new imaging agent called 18F-fluciclovine to see how well it can detect advanced prostate cancer that has low levels of prostate-specific membrane antigen (PSMA) or shows neuroendocrine features. This pilot study is the first time 18F-fluciclovine is being examined for these specific types of prostate cancer, which are hard to see using standard imaging. The study aims to better understand the role of amino acids and PSMA in these cancers and how imaging tests can improve treatment options. Participants will receive an 18F-fluciclovine PET/CT scan within 6 weeks of their standard care exams, including a 68Ga-PSMA PET/CT scan. Along with the scans, they will have two blood samples collected—one at the time of the 18F-fluciclovine scan and another before starting treatment as decided by their primary oncologist. The radioactive imaging agent 18F-fluciclovine targets amino-acid receptors in tumors and is combined with PET/CT technology to create detailed images. During the study, participants will undergo imaging tests and blood draws to help researchers measure how well 18F-fluciclovine and PSMA show cancer spread in the body over up to six months. The study will closely monitor how these imaging agents are taken up by tumors. Participants must be able to follow study procedures and use contraception due to unknown effects on developing fetuses. The total time involved includes initial imaging and blood testing, with ongoing evaluation of imaging results.
CONDITIONS
Brief 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...
- Male participants aged 18 years or older
- Histologically confirmed metastatic prostate cancer with either castration resistant prostate cancer (CRPC) and PSMA-low disease (SUVmean 64 10 with at least 5 metastatic lesions) or neuroendocrine prostate cancer confirmed by biopsy
- At least 5 metastatic lesions present
- Have had or plan to have standard 68Ga-PSMA PET/CT scan before or after 18F-fluciclovine PET/CT
- ECOG performance status of 0, 1, or 2 (Karnofsky 60%)
- Ability and willingness to follow study procedures
- Agree to use effective contraception before and for 24 hours after PET/CT scan
- Ability to understand and sign informed consent
You will not qualify if you...
- Presence of other active cancers requiring treatment
- History of allergic reaction to compounds chemically similar to 18F-fluciclovine
- Uncontrolled illnesses such as active infection, severe heart failure, unstable angina, arrhythmia, or psychiatric conditions limiting study compliance
- Contraindications to PET/CT such as severe claustrophobia
- Any condition that may affect study results or pose extra risk as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants undergo imaging scans including standard 68Ga-PSMA PET/CT and 18F-fluciclovine PET/CT to detect PSMA-low and neuroendocrine prostate cancer.
1 to 2 visits (in-person), including the 18F-fluciclovine PET/CT and standard of care scan
Duration - Within the diagnostic period
Participants have two blood tests collected at the time of the 18F-fluciclovine PET/CT scan and prior to treatment as determined by their primary oncologist.
2 blood collection visits (in-person)
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
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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