Actively Recruiting
Usefulness of Tumor Heterogeneity Assessment in Patients With MCRPC Undergoing Radioligand Therapy With 177LU-PSMA-617 Using Serial 18F-DCFPYL, 18F-FDG and 18F-Fluciclovine PET/CT Predicting Clinical Outcome
Led by VA Greater Los Angeles Healthcare System · Updated on 2024-11-27
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) to understand how different PET/CT scans can predict outcomes during radioligand therapy with 177Lu-PSMA-617. This is an exploratory, prospective study conducted at a single center, focusing on imaging tumor heterogeneity to help assess therapy effects and patient response. The study is designed specifically for Veterans undergoing this treatment. Participants will receive several types of PET/CT scans at different times: before starting LuPSMA radioligand therapy (RLT), and then after the 2nd, 4th, and 6th treatment cycles. These scans include 18F-Fluciclovine PET/CT (Axumin), 18F-DCFPyL PET/CT, and 18F-FDG PET/CT. The 18F-Fluciclovine scans will be performed within seven days of the PSMA PET scans to compare imaging results at each time point. During the study, detailed imaging measures such as lesion uptake and tumor volume will be collected and analyzed over time. Patients will be followed at the institution to correlate these imaging results with clinical outcomes. The main outcome measured is the impact of 18F-Fluciclovine PET/CT on predicting outcomes of the 177Lu-PSMA-617 therapy from enrollment through 34 weeks of treatment.
CONDITIONS
Brief Title
18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with metastatic castration-resistant prostate cancer scheduled to undergo Lutetium PSMA radioligand therapy
- Willingness to have multiple serial PET/CT scans before and after therapy
- Ability to provide written informed consent
You will not qualify if you...
- Younger than 18 years at time of radiopharmaceutical administration
- Medical conditions or serious illnesses that may interfere with study procedures or compliance
- Contraindications to Lutetium PSMA radioligand therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 34 weeks
Participants undergo Lutetium PSMA radioligand therapy and have serial 18F-Fluciclovine PET/CT scans to assess tumor heterogeneity and predict clinical outcome.
5 PET/CT scans: 1 baseline (pre-treatment) and 4 post-treatment scans after the 2nd, 4th, and 6th therapy cycles
Trial Site Locations
Total: 1 location
1
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
Actively Recruiting
Research Team
G
Gholam Berenji, MD
J
Janake Wijesuriya, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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