Detecting Recurrent Prostate Cancer With 11C-choline Positron Emission Tomography
1 other identifier
expanded_access
N/A
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
5 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2015
CompletedFirst Posted
Study publicly available on registry
August 24, 2015
CompletedJune 5, 2020
June 1, 2020
August 20, 2015
June 4, 2020
Conditions
Keywords
Interventions
Eligibility Criteria
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 ≥ 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.
You may not qualify if:
- Patient must not have claustrophobia that would preclude PET/CT imaging or other contraindications to CT imaging.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Memoral Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
Commack, New York, 11725, United States
Memoral Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heiko Schӧder, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- expanded access
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2015
First Posted
August 24, 2015
Last Updated
June 5, 2020
Record last verified: 2020-06