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.
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.
Patient is older than 18-year-old Biopsy proven prostate adenocarcinoma Planned prostatectomy with lymph node dissection 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) Able to provide written consent Karnofsky performance status of ³50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent)
Exclusion Criteria:
Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (HiFu) Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging surgery Metallic implants (contraindicated for MRI)
