Study on 18F-DCFPyL PET/CT Imaging for High Risk and Recurrent Prostate Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT03181867

Provider View

This clinical trial is exploring a new imaging method using a radiotracer called 18F-DCFPyL to better detect prostate cancer in men who are at high risk of the cancer spreading or who have signs of the cancer returning after treatment.

Patient Parameters

Program Overview

Prostate cancer is a major health concern for men, being the second leading cause of cancer deaths. When the cancer is confined to the prostate, it can often be cured, but if it spreads or returns after treatment, more therapy might be needed. Current imaging methods have limitations, so researchers are testing a new radiotracer, 18F-DCFPyL, to see if it can better identify prostate cancer in men who are at high risk of the cancer spreading or who have signs of recurrence after treatment.

Description

This study is investigating a new imaging technique using 18F-DCFPyL, a radiotracer that may help in accurately identifying prostate cancer that is either high risk or has returned after treatment. Prostate cancer is a leading cause of cancer death among men, and early detection of recurrence can be beneficial. Current imaging methods like CT and MRI have limitations, so this study aims to see if 18F-DCFPyL can provide better results.

Participants will be divided into two groups:

  • Group 1 includes men with newly diagnosed high-risk prostate cancer who are scheduled for surgery or biopsy before radiation therapy.
  • Group 2 includes men who have signs of prostate cancer returning after surgery or radiation.

Both groups will undergo PET/CT scans using 18F-DCFPyL. Participants will lie still on a table while the machine takes images of their body. The radiotracer will be injected through an IV line. Follow-up contact will be made after the scans.

Group 1 participants may have surgery to remove the prostate or a biopsy, which is standard care and not part of the study. They will also have an extra MRI scan of the prostate, which involves placing a tube in the rectum and using a contrast agent.

Group 2 participants may also have an MRI of the pelvis and a biopsy of any abnormalities found on the 18F-DCFPyL scan. Data about their prostate cancer will be collected for up to one year.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 years or older.
  • Have a confirmed diagnosis of prostate cancer.
  • Fit into one of the following categories:
    • Group 1: Newly diagnosed high-risk prostate cancer with evidence of disease on standard imaging.
    • Group 2: Signs of prostate cancer returning after treatment, with a PSA level of 0.2 ng/mL or higher.
  • Willing to undergo a research biopsy if needed.
  • Agree to use effective contraception during the study and for two months after the 18F-DCFPyL scan.

Exclusion Criteria

  • Participation would delay scheduled standard care therapy.
  • Have medical or psychiatric conditions that could interfere with the study.
  • Severe claustrophobia not relieved by medication.
  • Other medical conditions that make participation unsafe.
  • Weigh more than 350 lbs or cannot fit in the imaging machine.
  • Have high serum creatinine levels.

Locations

FACILITYZIPCITYSTATE
National Institutes of Health Clinical Center20892BethesdaMaryland

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