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

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ClinicalTrials.gov Identifier: NCT02531672
Expanded Access Status : No longer available
First Posted : August 24, 2015
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Prostate Cancer Recurrent Prostate Cancer Drug: 11C-choline Device: PET/CT Scan

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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531672


Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, United States, 07920
Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, United States, 07645
United States, New York
Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
Commack, New York, United States, 11725
Memoral Sloan Kettering Westchester (Consent only)
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Heiko Schӧder, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02531672    
Other Study ID Numbers: 15-117
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
11C-choline
Positron Emission Tomography
15-117
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents