Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT
A Pilot Study for Detection of PSMA-Low Castration Resistant and Neuroendocrine Prostate Cancer With 18F-fluciclovine PET/CT Imaging
1 other identifier
interventional
30
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2024
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2023
CompletedFirst Posted
Study publicly available on registry
October 2, 2023
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
November 5, 2025
November 1, 2025
2.6 years
September 13, 2023
November 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Fluciclovine and PSMA Uptake in PSMA Positive Tumors
Number of 18F-fluciclovine positive lesions in PSMA-positive tumors on PET Number of fluciclovine positive tumors that are PSMA-negative
Up to 6 months
Fluciclovine and PSMA Uptake in PSMA Negative Tumors
Number of 18F-fluciclovine positive lesions in PSMA-negative tumors on PET
up to 6 months
Study Arms (1)
18F-fluciclovine
EXPERIMENTALParticipants 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
Interventions
18F-fluciclovine is a radiotracer targeting amino-acid transporters.Radiotracers are compounds or drugs that are attached to small amounts of a radioactive substance to make images of processes that are happening in the body
Positron emission tomography/computed tomography (PET/CT) uses small amounts of radioactive materials called radiotracers, a special camera and a computer to help evaluate organ and tissue functions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Blue Earth Diagnosticscollaborator
Study Sites (2)
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Brigham and Womens Hospital
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather Jacene, MD
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 13, 2023
First Posted
October 2, 2023
Study Start
February 1, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2028
Last Updated
November 5, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.