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Fluciclovine PET/CT Imaging for Prostate Cancer

Phase 1
Recruiting
Led By Heather Jacene, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
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.
Must not have
Participants with other known malignancy requiring treatment
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Summary

This trial studies an imaging agent to detect prostate cancer with low/neuroendocrine features. Two blood collections are also part of the trial.

Who is the study for?
This trial is for men aged 18 or older with advanced prostate cancer that has spread and shows low PSMA levels or neuroendocrine features. They must have a decent performance status, be able to follow the study procedures, and agree to use contraception. Those with uncontrolled illnesses, severe claustrophobia, other cancers needing treatment, or allergies to similar compounds cannot join.
What is being tested?
The study tests how well an imaging agent called 18F-fluciclovine works in PET/CT scans for detecting advanced prostate cancer with specific characteristics. Participants will undergo the special scan and provide two blood samples for research purposes.
What are the potential side effects?
While detailed side effects of 18F-fluciclovine are not provided here, radiopharmaceuticals can sometimes cause mild reactions like nausea or a metallic taste in the mouth. The PET/CT procedure itself is generally safe but may pose risks related to radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have prostate cancer that has spread, with specific test results or biopsy findings.
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I am 18 years old or older.
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I can take care of myself but might not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have another cancer that needs treatment.
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I am allergic to substances similar to 18F-fluciclovine.
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I do not have any serious illnesses that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fluciclovine and PSMA Uptake in PSMA Negative Tumors
Fluciclovine and PSMA Uptake in PSMA Positive Tumors

Trial Design

1Treatment groups
Experimental Treatment
Group I: 18F-fluciclovineExperimental Treatment2 Interventions
Participants with low prostate-specific membrane antigen (PSMA) expression or neuroendocrine prostate cancer will receive: * 18F-fluciclovine PET/CT within 6 weeks of standard of care exam and 68Ga-PSMA PET/CT * 2x Blood test at time of 18F-fluciclovine PET/CT and prior to treatment as determined by participants primary oncologist
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PET/CT
2022
Completed Phase 3
~1300
18F-fluciclovine
2021
Completed Early Phase 1
~40

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,101 Previous Clinical Trials
358,067 Total Patients Enrolled
77 Trials studying Prostate Cancer
15,698 Patients Enrolled for Prostate Cancer
Blue Earth Diagnostics, IncUNKNOWN
4 Previous Clinical Trials
129 Total Patients Enrolled
1 Trials studying Prostate Cancer
50 Patients Enrolled for Prostate Cancer
Brigham and Women's HospitalLead Sponsor
1,655 Previous Clinical Trials
11,499,580 Total Patients Enrolled
23 Trials studying Prostate Cancer
32,802 Patients Enrolled for Prostate Cancer
~20 spots leftby Sep 2026
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