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New treatment option for Advanced Prostate Cancer
Official title Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT
ClinicalTrials.gov ID: NCT06062745
What this study is testing
What is 18F-fluciclovine?
18F-fluciclovine is an investigational medicine, being studied as a potential treatment for advanced prostate cancer.
Also referred to as Axumin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Participants must have histologically confirmed prostate cancer that is metastatic and one of the following: CRPC with PSMA-low disease defined by...
- 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...
- 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...
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Ability and willingness to comply with the study procedures.
You likely can't join 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...
- 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...
See the full eligibility 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...
- 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...
- 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...
- Ability to understand and the willingness to sign a written informed consent document
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.