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

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial Description

This research study is a pilot study, which is the first-time investigators are examining this study imaging agent, 18F-fluciclovine, for use in PSMA-low castration resistant and neuroendocrine prostate cancer detection. 18F-fluciclovine is approved by the U.S. Food and Drug Administration (FDA). It is approved for imaging the early stages of prostate cancer. It is not approved for imaging PSMA-low castration resistant or neuroendocrine prostate cancer. 18F-fluciclovine is a radiotracer for PET imaging that targets amino-acid receptors. Some information shows that both PSMA-low and neuroendocrine prostate tumors use amino acids for energy. The purpose of this study to determine if PSMA-low and neuroendocrine prostate cancer can be seen with 18F-fluciclovine-PET/CT. Secondary aims are better understanding of the role of amino acids and PSMA in PSMA low and neuroendocrine prostate cancer and how imaging tests can be used together to optimize treatments for PSMA-low and neuroendocrine prostate cancer. Participants will receive a PSMA-PET/CT as part standard of care and as part of the study receive 18F-fluciclovine-PET/CT scan along with two research blood collections. Blue Earth Diagnostics Inc. is supporting this research study by providing the 18Ffluciclovine and funding for the research study. ;

Study Design

Related Conditions & MeSH terms

Advanced Prostate Cancer
Carcinoma, Neuroendocrine
Metastatic Prostate Cancer
Metastatic Prostate Neuroendocrine Carcinoma
Prostatic Neoplasms

Clinical Trial Details

NCT number	NCT06062745
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact	Heather Jacene, MD
Phone	617-632-3767
Email	hjacene@partners.org
Status	Not yet recruiting
Phase	Phase 1
Start date	February 2024
Completion date	September 1, 2028

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms