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Pilot Study for Detecting PSMA-Low Advanced Prostate Cancer with Fluciclovine PET/CT

This study is looking at how well a special imaging agent, 18F-fluciclovine, can find advanced prostate cancer that is either 'PSMA-low' (meaning it has low levels of a protein called PSMA) or has neuroendocrine features. You might be able to join if you are a man with metastatic (spread) prostate cancer that is castration-resistant (meaning it no longer responds to hormone therapy) and is either PSMA-low or has neuroendocrine features based on a biopsy. The study will measure how much 18F-fluciclovine and PSMA are taken up by tumors over six months to see if 18F-fluciclovine-PET/CT scans can effectively detect these types of prostate cancer. The study is currently unclear on its recruitment status.

Study design
This is a pilot study, meaning it's the first time researchers are testing 18F-fluciclovine for this specific use. It plans to enroll 30 participants.
What's involved
You will receive a standard PSMA-PET/CT scan, an 18F-fluciclovine-PET/CT scan, and have two research blood collections.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes for up to 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06062745

Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Brigham and Women's Hospital
~30 participants
Updated 2025-11-05 on ClinicalTrials.gov
What's tested:18F-fluciclovinePET/CT

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fluciclovine and PSMA Uptake in PSMA Positive Tumors
Measured over Up to 6 months
+1 more outcome measured

Conditions

Advanced Prostate Cancer
Metastatic Prostate Cancer
Metastatic Prostate Neuroendocrine Carcinoma

Explore related trials

Prostate CarcinomaProstate Neuroendocrine CarcinomaFOLH1 Gene

Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Heather Jacene, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Heather Jacene, MD
[email protected]
617-632-3767
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants must have histologically confirmed prostate cancer that is metastatic and one of the following: CRPC with PSMA-low disease defined by whole-body SUVmean ≤ 10 determined by standard-of-care 68Ga-PSMA-11 PET/CT imaging with at least 5 metastatic lesions OR NEPC pathology based on tumor biopsy. This may include morphology consistent with small cell carcinoma or mixed adenocarcinoma/NE features and/or IHC staining for NE markers. Participants should have at least 5 metastatic lesions.
Must have either already had standard of care 68Ga-PSMA PET/CT scan or be planned for 68Ga-PSMA PET/CT scan before or after the planned 18F-fluciclovine-PET/CT.
Age ≥18 years. Since no dosing or adverse event data are currently available on the use of 18F-fluciclovine in participants \<18 years of age, and most prostate cancer occurs in the adult population, children are excluded from this study but will be eligible for future pediatric trials.
ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
Ability and willingness to comply with the study procedures.
The effects of 18F-fluciclovine on the developing human fetus are unknown. For this reason and because radiopharmaceuticals may be teratogenic, men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for 24 hours after the PET/CT scan is completed.
Ability to understand and the willingness to sign a written informed consent document

Exclusion

Participants with other known malignancy requiring treatment
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Contraindications for PET/CT including:
Severe claustrophobia
Any past or current condition that in the opinion of the study investigators would confound the results of the study or pose additional risk to the patient by their participation in the study.

What this trial measures

  • Fluciclovine and PSMA Uptake in PSMA Positive TumorsUp to 6 months

    Number of 18F-fluciclovine positive lesions in PSMA-positive tumors on PET Number of fluciclovine positive tumors that are PSMA-negative

  • Fluciclovine and PSMA Uptake in PSMA Negative Tumorsup to 6 months

    Number of 18F-fluciclovine positive lesions in PSMA-negative tumors on PET