Genital Diseases, Male, Genital Neoplasms, Male, Male Urogenital Diseases, Metastatic Prostate Cancer, Neoplasms, Neoplasms by Site, Prostatic Diseases, Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant, Urogenital Diseases, Male, Urogenital Neoplasms
Conditions
Keywords
Prostate cancer, PET/CT, Radioligand Therapy, Metastatic Castration-Resistant Prostate Cancer, PSMA PET
Brief summary
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.
Detailed description
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.
Interventions
DRUG18F-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.
Sponsors
VA Greater Los Angeles Healthcare System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From enrollment to end of treatment at 34 weeks | Tumor volume on FDG, Axumin and DCFPyL PET/CT. Tumor volume is the amount of space a tumor occupies, measured in cubic centimeters (cc). |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. | From enrollment to end of treatment at 34 weeks | 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. |
Countries
United States
Contacts
Primary ContactGholam Berenji, MD
Backup ContactJanake Wijesuriya, BS
Outcome results
None listed