A Phase 4 interventional study of 18F-Fluciclovine PET/CT Scan in Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant and Metastatic Prostate Cancer, sponsored by VA Greater Los Angeles Healthcare System. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by VA Greater Los Angeles Healthcare System · Phase 4, Interventional, and Diagnostic
This a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18 fluorodeoxyglucose positron emission tomography/computed tomography 18F-FDG PET/CT and a 18F-DCFPyL PET/CT (18F-DCFPyL (2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid)positron emission tomography/computed tomography , as per standard of care in our institution. All patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (PSMA PET) after the 2nd, 4th, and 6th LuPSMA RLT cycle. In this prospective study, an18F-Fluciclovine positron emission tomography/computed tomography ( Axumin PET/CT )will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles. Axumin PET/CT will be acquired within 7 days from the PSMA PET.
This study is open to Veterans only.
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.
85 studies on the registry are indexed under Prostatic Neoplasms, Castration-Resistant; 28 are open to participants now.
This study's planned enrollment of 15 is below the median of 82 across 62 interventional studies indexed under Prostatic Neoplasms, Castration-Resistant.
Browse Prostatic Neoplasms, Castration-Resistant studies →VA Greater Los Angeles Healthcare System is the lead sponsor of 32 studies on the registry; 5 are open to participants now.
Compared within Prostatic Neoplasms, Castration-Resistant, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Prostatic Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects receive 18F-Fluciclovine PET/CT scans.
Drug: 18F-Fluciclovine PET/CT Scan
In this prospective study, an 18F-Fluciclovine PET/CT will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles.18F-Fluciclovine PET/CT will be acquired within 7 days from the PSMA PET.
18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer
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.
Time frame: From enrollment to end of treatment at 34 weeks.
Usefulness of Tumor Heterogeneity Assessment in Patients 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.
Tumor volume on FDG, Axumin and DCFPyL PET/CT. Tumor volume is the amount of space a tumor occupies, measured in cubic centimeters (cc).
Time frame: From enrollment to end of treatment at 34 weeks
Usefulness of Tumor Heterogeneity Assessment in Patients 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.
Percentage change in Whole-body and lesion-level SUVmean, SUVmax and tumor volume on FDG, Axumin and DCFPyL PET/CT pre- and post LuPSMA therapy. A "percentage change" refers to the calculated percentage difference between a initial value ( pre LuPSMA ) and a later measurement ( post LuPSMA ), essentially showing how much the tumor has grown or shrunk compared to its baseline size.
Time frame: From enrollment to end of treatment at 34 weeks
Plan to share: Undecided — Study results are unknown at this time. The plan will be reevaluated once the results come in.
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Prostatic Neoplasms, Castration-Resistant →
VA Greater Los Angeles Healthcare System