Recruiting
Phase 1

18F-Fluciclovine

Sponsor:

Brigham and Women's Hospital

Code:

NCT06062745

Conditions

Advanced Prostate Cancer

Metastatic Prostate Cancer

Metastatic Prostate Neuroendocrine Carcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-fluciclovine

PET/CT

Study Details

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

Conditions

Advanced Prostate Cancer

Metastatic Prostate Cancer

Metastatic Prostate Neuroendocrine Carcinoma

Study ID

NCT06062745

Start date

Feb 1, 2024

Status verified date

Nov, 2025

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 18F-fluciclovine

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

Interventions

18F-fluciclovine

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

PET/CT

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.

Primary outcome measure

  • Fluciclovine and PSMA Uptake in PSMA Positive Tumors [ Time Frame: Up to 6 months ]
  • Fluciclovine and PSMA Uptake in PSMA Negative Tumors [ Time Frame: up to 6 months ]

Central Contacts and Locations

Central contacts

Heather Jacene, MD

617-632-3767hjacene@partners.org

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Heather Jacene, MD

617-632-3767hjacene@partners.org

Principal Investigator:

Heather Jacene, MD

Brigham and Womens Hospital

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Heather A Jacene, MD

617-632-3767hjacene@partners.org

Principal Investigator:

Heather A Jacene, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Nov 5, 2025

Last verified

Nov, 2025

Keywords

  • Advanced Prostate Cancer
  • Metastatic Prostate Cancer
  • Metastatic Prostate Neuroendocrine Carcinoma
  • PSMA-Low Castration Resistant Prostate Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-11-05.