NCT03173924

18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer

Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: Prostate cancer is the second leading cause of cancer deaths in American men. Few options exist to create images of this type of cancer. Researchers think an experimental radiotracer called 18F-DCFPyL could find sites of cancer in the body. Objective: To see if 18F-DCFPyL can identify sites of prostate cancer in people with the disease. Eligibility: People ages 18 and older who have metastatic prostate cancer Design: Participants will be screened with: * Blood tests * Physical exam * Medical history Participants will be assigned to 1 of 2 groups based on their PSA. Participants will have 18F-DCFPyL injected into a vein. About 2 hours later they will have a whole-body Positron Emission Tomography/Computed Tomography (PET/CT). For the scan, they will lie on their back on the scanner table while it takes pictures of the body. This lasts about 50 minutes. On another day, participants will have 18F -NaF injected into a vein. About 1 hour later, they will have a whole-body PET/CT. Participants will be contacted 1 3 days later for follow-up. They may undergo PET/Magnetic Resonance Imaging (MRI) either after having a 18F-DCFPyL PET/CT, or in place of PET/CT imaging. A tube may be placed in the rectum. More coils may be wrapped around the outside of the pelvis. If the 18F-DCFPyL PET/CT is positive participants will be encouraged to undergo a biopsy of one of the tumors. The biopsy will be taken through a needle put through the skin into the tumor. Participants will be followed for 1 year. During this time researchers will collect information about their prostate cancer, such as PSA levels and biopsy results. About 4-6 months after scanning is completed, participants may have a tumor biopsy. The biopsy will be taken through a needle put through the skin into the tumor. ...

Detailed description

Background: The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), \[18F\] DCFPyL (DCFPyL) PET/CT (or PET/MRI imaging if available) for detection of metastatic prostate cancer PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential Our preliminary first-in-human studies demonstrate high specific uptake of a first generation less avid compound, DCFBC, in metastatic prostate cancer and demonstrated feasibility for prostate cancer metastatic detection. We propose to assess the ability of DCFPyL PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected bony metastatic disease detected by ultra-sensitive but less specific \[18F\] Sodium Fluoride (NaF)-PET/CT imaging and all sites of suspected disease detected by \[18F\] Fluorodeoxyglucose (FDG) for prostate cancer. Objective: To compare the diagnostic sensitivity of DCFPyL-PET/CT (or PET/MRI imaging if available) to NaF-PET/CT for detection of prostate cancer bone metastasis based on comparison to reference standard of care conventional imaging modalities (CIM); such as CT and whole body bone scintigraphy incorporating prior and follow-up scans and histopathology when available. Eligibility: Histological confirmation of prostate cancer Age \>=18 years old Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2. Patients must have either: * Confirmation of prostate cancer with identifiable metastatic disease on at least 1 clinically indicated imaging modality. If there is only soft tissue metastasis, one lesion must measure at least 6 mm or greater. OR * Documented history of metastatic prostate cancer. Design: Two Cohort study Cohort 1: Stable/Decreasing Prostate Specific Antigen (PSA): PSA must be equal to or less than 0.5 ng/mL value of the last PSA obtained (at least one month apart) Cohort 2: Rising PSA: PSA must be greater than 0.5 ng/mL above the last PSA value obtained on at least two occasions within 1 year Patients will undergo DCFPyL PET/CT (or PET/MRI), NaF-PET/CT, and FDG PET/CT within 21 days of each other. The order obtained does not matter. The DCFPyL PET/CT (or PET/MRI) will be compared with the NaF-PET/CT and FDG PET/CT and standard chest/abdomen/pelvis CT. DCFPyL PET/CT (or PET/MRI) detection of metastatic disease will be assessed by visual qualitative assessment as positive, equivocal, or negative. Sites of equivocal or positive metastatic disease will have a quantitative PET assessment (SUVmax, SUVmean). A mandatory research biopsy will be performed under image guidance on a suspicious lesion, if feasible. The patients will be followed yearly for 4 years by chart review, phone-call, email or any other NIH approved platform for PSA relapse and radiologic evidence of metastatic disease. Additional 18F-DCFPyL and 18F-FDG PET/CTs might be performed during the subject s follow up period there has been a considerable change in patient status (progression or response) based on PSA value, symptomatology, bone scan or CT findings.

Conditions

• Metastatic Prostate Cancer
• Prostatic Neoplasms
• Prostate Cancer
• Prostatic Cancer
• Prostate Neoplasms

Interventions

Type	Name	Description
DRUG	18F-NaF	Baseline IV followed by PET/CT IMAGING
DRUG	18F-DCFPyL	Baseline IV followed by PET/CT IMAGING. Additional 18F-DCFPyL PET/CTs might be performed during the subject s follow up period if, in the opinion of the referring clinician, there has been a considerable change in patient status (progression or response) based on clinical grounds/PSA value or to help assess changes of standard of care therapy.
DRUG	18F-FDG	Baseline IV followed by PET/CT IMAGING. Additional 18F-FDG PET/CTs may be obtained per PI discretion within a 21-day window relative to each 18F-DCFPyL PET/CTs.

Timeline

• Start date: 2017-06-06
• Primary completion: 2028-02-06
• Completion: 2028-02-06
• First posted: 2017-06-02
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study