Prostate Cancer
Conditions
Brief summary
The purpose of this research study is to see if patients' tumor can be identified by 18F-DCFPyL PET/MRI scan. The radioactive study agent, 18FDCFPyL, combined with PET/MRI scan may be able to identify smaller tumors than the standard of care contrast-enhanced CT or MRI scan.
Detailed description
This is an expanded access study with a total of 100 participants with newly diagnosed intermediate or high-risk prostate cancer scheduled to undergo prostatectomy and lymph node dissection.
Interventions
DRUGF18-DCFPyL
Participant will be injected iv with 9 mCi ± 20% of 18F-DCFPyL
DRUGGadolinium
Contrast agent
PROCEDUREPositron emission tomography (PET)/Magnetic Resonance Imaging (MRI) Scan
Imaging test that combines PET (positron emission tomography) and MRI (magnetic resonance imaging)
Sponsors
Stanford University
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Inclusion criteria
1. Patient is older than 18-year-old 2. Biopsy proven prostate adenocarcinoma 3. Planned prostatectomy with lymph node dissection 4. Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) \[PSA\>10\], T-stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors) 5. Able to provide written consent 6. Karnofsky performance status of ³50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent)
Exclusion criteria
1. Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (HiFu) 2. Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging surgery 3. Metallic implants (contraindicated for MRI)
Countries
United States
Outcome results
None listed