Evaluation of PSMA-based PET as an Imaging Biomarker in Prostate Cancer

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

This research is being done to see if an investigational radioactive imaging agent (radiotracer) called 18F-DCFPyL can help us find prostate cancer at its original site in the prostate gland and in distant sites (bone, lymph nodes) in men diagnosed with prostate cancer before surgery.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Men 18 years of age or greater with recently diagnosed prostate cancer with planned radiation and ADT.

• Key inclusion criteria (the entire list of inclusion and exclusion criteria will appear later in section 4 of the protocol)

• Newly diagnosed prostate cancer pathologically proven by prostate biopsy

• Prostate biopsy histology grade ≥ Gleason 8-10

• Patients considered as candidates for and medically fit to undergo radiation and ADT

• At least 10 days after most recent prostate biopsy

Exclusion Criteria:

• Prior pelvic external beam radiation therapy or brachytherapy

• Chemotherapy for prostate cancer

• Hormone deprivation therapy

• Investigational therapy for prostate cancer

• Hemorrhagic cystitis or active prostatitis