Detecting Recurrent Prostate Cancer With C-11 Choline Positron Emission Tomography: An Expanded Access Study

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Conditions studied: Cancer of the Prostate

In brief

The purpose of this study is to provide clinical access to PET/CT and PET/MRI with C-11 choline for evaluation of men with biochemically recurrent prostate cancer while awaiting approval of the Washington University Abbreviated New Drug Application for C-11 choline.

Key facts

Study ID

NCT02355054

Run by

Washington University School of Medicine

Last updated by the study team

2017-01-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patient must have biopsy-proven adenocarcinoma of the prostate initially treated with curative intent (surgery and radiation therapy are most common treatments but other treatments are also eligible).
• Biochemical recurrence defined as any of the following:
• PSA ≥ 0.2 ng/mL in at least two sequential tests for patients treated with surgery.
• PSA ≥ 2.0 ng/mL above the post therapy nadir for patients treated with radiation therapy, brachytherapy or cryotherapy.
• PSA ≥ 2.0 ng/ml above the most recent therapy nadir for patients who have received additional treatment in the recurrent setting.
• Patient must have undergone standard-of-care restaging that does not clearly identify site(s) of active disease. Standard staging examinations may include one or more of the following: CT or MRI, bone imaging (either Tc-99m bisphosphonate scintigraphy or F-18 sodium fluoride PET), OR In-111 capromab pendetide scintigraphy.
• Age > 18 years.
• Patient must be able to tolerate PET/MRI or PET/CT imaging
• Patient must be able to understand and willing to sign a written informed consent document.
• Patient must be able to understand and willing to sign an Advance Beneficiary Notice (ABN) (Medicare patient) or a Notice of Non-coverage (NNC) from (non-Medicare patient) that addresses the potential cost to the patient of C-11 choline PET/CT or PET/MRI.

You may not qualify if…

• For patients planned to have PET/MRI:
• Patient must not have claustrophobia or any other contraindication to MRI as evaluated by a standardized MRI safety questionnaire.
• If applicable, patient must not have renal insufficiency (estimated glomerular filtration rate < 30 mL/min/1.73 m2 based on measurement within the past 60 days) or be undergoing dialysis as these conditions preclude safe administration of MRI contrast agents. NOTE: At the discretion of principal investigator, a subject may be allowed to enroll/continue on study and undergo imaging without the administration of contrast in the event of renal insufficiency.
• If applicable, patient must not have a known prior reaction to gadolinium based MRI contrast agents.
• For patients planned to have PET/CT:
• Patient must not have claustrophobia that would preclude PET/CT imaging or other contraindications to CT imaging.

Where it is running

• Washington University School of Medicine, Barnes-Jewish Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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