Detecting low PSMA prostate cancer using a special PET scan
A Pilot Study for Detection of PSMA-Low Castration Resistant and Neuroendocrine Prostate Cancer With 18F-fluciclovine PET/CT Imaging
This study is testing a new type of PET scan to see if it can better detect advanced prostate cancer that has low PSMA levels or neuroendocrine features in patients.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06062745 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with metastatic prostate cancer that is either castration-resistant with low PSMA expression or has neuroendocrine features.
Not a fit: Patients with localized prostate cancer or those without metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and treatment strategies for patients with advanced prostate cancer that currently lacks effective imaging options.
How similar studies have performed: While this approach is novel for PSMA-low and neuroendocrine prostate cancer, similar imaging techniques have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.