18F-Fluciclovine PET/CT for Predicting Outcomes in Prostate Cancer Patients Receiving 177Lu-PSMA-617 Therapy

This study is looking at how a special type of scan, called an 18F-Fluciclovine PET/CT, can help predict how well men with metastatic castration-resistant prostate cancer (mCRPC) will respond to a treatment called 177Lu-PSMA-617 (LuPSMA RLT). Researchers will take these scans at the beginning of treatment and after the 2nd, 4th, and 6th cycles of LuPSMA RLT. They will compare the scan results with your clinical outcome to see if the scans can predict how effective the treatment will be for you. You can join if you are an adult man with mCRPC who is scheduled to receive LuPSMA RLT and are willing to have several scans. The study aims to understand if these scans can help doctors better predict treatment success. The current status of this study is unclear, and it plans to enroll 15 participants.

Study design
This is a single-center, exploratory study without a specified phase, involving about 15 participants.
What's involved
You would undergo multiple 18F-Fluciclovine PET/CT scans at baseline and after the 2nd, 4th, and 6th cycles of LuPSMA RLT. These scans will be done within 7 days of your PSMA PET scans.
Compensation
Not stated in the trial record.
Follow-up
Your clinical outcome will be followed from enrollment until the end of treatment, which is approximately 34 weeks.

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NCT06706921

18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer

Recruiting
PHASE4Ages 18+InterventionalDiagnostic
VA Greater Los Angeles Healthcare System
~15 participants
Updated 2024-11-27 on ClinicalTrials.gov
What's tested:18F-Fluciclovine PET/CT Scan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer
Measured over From enrollment to end of treatment at 34 weeks.
Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Metastatic Prostate Cancer
Male Urogenital Diseases
Prostatic Diseases
Urogenital Diseases, Male
Genital Diseases, Male
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Genital Neoplasms, Male
1 sites across 1 states
California1

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Eligibility criteria

Inclusion

Patients with mCRPC scheduled to undergo LuPSMA RLT.
Willingness to undergo multiple serial PET/CT scans pre- and post-LuPSMA RLT.
Ability of providing written informed consent.

Exclusion

Less than 18 years-old at the time of radiopharmaceutical administration.
Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.
Contraindications to LuPSMA RLT.
  • 18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate CancerFrom enrollment to end of treatment at 34 weeks.

    Whole-body and lesion-level SUVmean, SUVmax. SUVmax, or maximum standardized uptake value, is a measurement used in positron emission tomography (PET) scans to quantify how much glucose a tumor is metabolizing.