Detecting low PSMA prostate cancer using a special PET scan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study evaluates the effectiveness of 18F-fluciclovine PET/CT scans in detecting advanced prostate cancer with low prostate-specific membrane antigen (PSMA) expression or neuroendocrine features. Participants will undergo standard PSMA-PET/CT scans and receive the investigational 18F-fluciclovine PET/CT scan, along with two blood collections for research purposes. The study aims to determine if this imaging agent can visualize PSMA-low and neuroendocrine prostate tumors, which may utilize amino acids for energy. The findings could enhance understanding of these cancer types and improve treatment optimization.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Brigham and Womens Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Heather Jacene, MD — Dana-Farber Cancer Institute
• Study coordinator: Heather Jacene, MD
• Email: hjacene@partners.org
• Phone: 617-632-3767

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.