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Fluciclovine PET/CT Imaging for Prostate Cancer

Q: Has 18F-fluciclovine been given clearance by the FDA?

<p>The safety rating of 18F-fluciclovine is 1 due to the limited clinical data available from its Phase 1 trial, which does not provide sufficient evidence for efficacy.</p>

Q: Does this research endeavor currently have active recruitment?

<p>The clinicaltrial.gov registry indicates that this study is no longer searching for participants, as the last update was on September 25th 2023. However, a variety of other trials are recruiting at present with 1339 studies open to candidates.</p>

Phase 1

Waitlist Available

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

~1240

18F-fluciclovine

2021

Completed Early Phase 1

~40

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,080 Previous Clinical Trials

341,203 Total Patients Enrolled

77 Trials studying Prostate Cancer

16,105 Patients Enrolled for Prostate Cancer

Blue Earth Diagnostics, IncUNKNOWN

4 Previous Clinical Trials

140 Total Patients Enrolled

1 Trials studying Prostate Cancer

50 Patients Enrolled for Prostate Cancer

Blue Earth DiagnosticsIndustry Sponsor

38 Previous Clinical Trials

2,957 Total Patients Enrolled

11 Trials studying Prostate Cancer

1,327 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has 18F-fluciclovine been given clearance by the FDA?

"The safety rating of 18F-fluciclovine is 1 due to the limited clinical data available from its Phase 1 trial, which does not provide sufficient evidence for efficacy."

Answered by AI

Does this research endeavor currently have active recruitment?

"The clinicaltrial.gov registry indicates that this study is no longer searching for participants, as the last update was on September 25th 2023. However, a variety of other trials are recruiting at present with 1339 studies open to candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Heather A. Jacene, MD 2024. "Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06062745.

All > Advanced Prostate Cancer