Study on PSMA-Targeted 18F-DCFPyL PET/MRI for Detecting Prostate Cancer

Sponsor: Northwestern University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04910425

Provider View

This clinical trial is testing a new imaging method using 18F-DCFPyL PET/MRI to help diagnose prostate cancer in men with elevated PSA levels. The study aims to see how well this method works compared to standard MRI scans.

Patient Parameters

Program Overview

This study is exploring a new way to diagnose prostate cancer using a special imaging technique called 18F-DCFPyL PET/MRI. This method uses a radioactive substance that attaches to prostate cancer cells, making them easier to see on scans. The goal is to compare this new method to the standard MRI scans to see which is better at identifying prostate cancer in men who have not had a biopsy yet but have high PSA levels.

Description

The main goal of this study is to compare the effectiveness of a new imaging method, 18F-DCFPyL PET, with the standard multiparametric MRI (mpMRI) in diagnosing significant prostate cancer in men who have not had a biopsy before. The study will also look at how well the combination of PET and mpMRI works compared to mpMRI alone, and how accurate each method is on its own.

Participants will receive an injection of the 18F-DCFPyL tracer and undergo a PET/MRI scan. They will also have an MRI scan with a contrast agent, as decided by the radiologist. Within about 60 days, participants will have a prostate biopsy guided by ultrasound, which is a standard procedure.

After the imaging and biopsy, participants will have follow-up visits within 24 hours and again at 30 days to monitor their health and gather more information.

Eligibility Criteria

Inclusion Criteria

  • Men with a positive screen for prostate cancer, indicated by a PSA level of 2 ng/mL or higher.
  • Willing to have a PHI blood test and a prostate biopsy as part of their regular medical care.
  • Must be 18 years or older.
  • Agree to use effective birth control or abstain from sex for 24 hours after the imaging.
  • Able to understand and willing to sign a consent form to participate in the study.

Exclusion Criteria

  • Have had a previous prostate biopsy.
  • Cannot have an MRI due to medical devices like pacemakers or metal clips.
  • Currently receiving other treatments or experimental drugs.
  • Have kidney function below a certain level, making it unsafe to receive contrast dye.
  • Have had a radioisotope treatment too recently before the study.
  • Have had an X-ray contrast dye injection too recently before the study.
  • Take multivitamins on the day of the study imaging.

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