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

Completed · Early Phase 1

Conditions studied: Advanced Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02420977

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

23

Starts

2018-12-06

Expected to finish

2025-03-01

Last updated by the study team

2025-03-19

Who can join

Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Curtiland Deville — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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