Study on Detecting Recurrent Prostate Cancer Using C-11 Choline PET Scans

Sponsor: Washington University School of Medicine

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02355054

Provider View

This study provides access to advanced imaging techniques, PET/CT and PET/MRI with C-11 choline, to help evaluate men with prostate cancer that has returned after initial treatment. The study is ongoing while awaiting drug approval.

Patient Parameters

Program Overview

The aim of this study is to offer men with recurrent prostate cancer access to specialized imaging tests, PET/CT and PET/MRI, using C-11 choline. These tests help doctors see if the cancer has returned after initial treatments like surgery or radiation. This study is available while waiting for official approval of the C-11 choline imaging method.

Eligibility Criteria

Inclusion Criteria

  • Must have been diagnosed with prostate cancer and treated with the goal of curing it (common treatments include surgery and radiation).
  • Must show signs of cancer returning, indicated by specific PSA levels:
    • PSA of 0.2 ng/mL or higher in two tests for those treated with surgery.
    • PSA of 2.0 ng/mL or higher above the lowest level after radiation, brachytherapy, or cryotherapy.
    • PSA of 2.0 ng/mL or higher above the lowest level after additional treatments for returning cancer.
  • Must have had standard tests that do not clearly show where the cancer is active. These tests may include CT or MRI scans, bone scans, or other specific imaging tests.
  • Must be over 18 years old.
  • Must be able to undergo PET/MRI or PET/CT scans.
  • Must understand and agree to sign a consent form.
  • Must understand and agree to sign a notice about potential costs of the C-11 choline PET/CT or PET/MRI.

Exclusion Criteria

  • For those having PET/MRI:
    • Must not have claustrophobia or other issues that prevent MRI scans.
    • Must not have severe kidney problems or be on dialysis, unless the scan can be done without contrast dye.
    • Must not have had a bad reaction to MRI contrast dye before.
  • For those having PET/CT:
    • Must not have claustrophobia or other issues that prevent PET/CT scans.

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