Detecting Recurrent Prostate Cancer With 11C-choline Positron Emission Tomography

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

The purpose of this study is to use a new imaging drug called 11C-choline that is used with a PET/CT scan to see prostate cancer when it cannot be seen well on other scans, such as bone scans, CT or MRI.

Inclusion Criteria:

• 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:

  1. PSA ≥ 0.2 ng/mL in at least two sequential tests for patients treated with surgery.
  2. PSA ≥ 0.2 ng/mL above the post therapy nadir for patients treated with radiation therapy, brachytherapy or cryotherapy.
  3. PSA ≥ 0.2 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, or such prior studies must show equivocal findings for which further work-up is considered necessary to make clinical decision. Standard staging examinations may include one or more of the following: CT or MRI, bone imaging (either Tc-99m bisphosphonate scintigraphy MDP or F-18 sodium fluoride PET), FDG PET, or In-111 capromab pendetide scintigraphy no older than 3 months of consent date.

• Age ≥ 18 years.

• Patient must be able to tolerate PET/CT imaging.

• Patient must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

• Patient must not have claustrophobia that would preclude PET/CT imaging or other contraindications to CT imaging.