RecruitingRecruiting
18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer
NCT06706921 · VA Greater Los Angeles Healthcare System
In plain English
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Official title
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
About this study
The imaging analysis will consist in obtaining quantitative measurements of lesion uptake on the pre- and post-LuPSMA RLT (lesion and whole-body SUVmax, SUVmean and tumor volume) at each time point on all PET/CT scans. PET metrics at the lesion- and whole-body level will be compared among different PET radiopharmaceuticals at the same time point, and changes over time will be assessed.
All patients will be followed-up at our institution and clinical outcome will be correlated to the imaging analysis assessment.
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
Study design
Enrollment target: 15 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-12-15
Estimated completion: 2027-11-01
Last updated: 2024-11-27
Interventions
Drug: 18F-Fluciclovine PET/CT Scan
Primary outcomes
- • 18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer (From enrollment to end of treatment at 34 weeks.)
Sponsor
VA Greater Los Angeles Healthcare System · fed
Contacts & investigators
ContactGholam Berenji, MD · contact · Gholam.Berenji@va.gov · 310-268-3547
ContactJanake Wijesuriya, BS · contact · Janake.Wijesuriya@va.gov · 310-977-5209
All locations (1)
VA Greater Los Angeles Healthcare SystemRecruiting
Los Angeles, California, United States