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

Memorial Sloan Kettering Cancer Center5 sites in 1 countryAugust 24, 2015

ConditionsProstate Cancer Recurrent Prostate Cancer

Drugs11C-choline

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Locations: 5
Status: No Longer Available
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 24, 2015

End Date

TBD

Last Updated

5 years ago

Study Type

Expanded Access

Sex

Male

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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:
•PSA ≥ 0.2 ng/mL in at least two sequential tests for patients treated with surgery.
•PSA ≥ 0.2 ng/mL above the post therapy nadir for patients treated with radiation therapy, brachytherapy or cryotherapy.
•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.