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



Status:Available
Conditions:Prostate Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/23/2018
Contact:Heiko Schӧder, MD
Phone:212-639-2079

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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.
We found this trial at
1
site
New York, New York 10065
Phone: 212-639-2079
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New York, NY
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