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

NCT ID: NCT02531672

Last Updated: 2020-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer Recurrent Prostate Cancer

Interventions

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11C-choline

Intervention Type DRUG

PET/CT Scan

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heiko Schӧder, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memoral Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, United States

Site Status

Memorial Sloan Kettering Bergen (Consent only )

Montvale, New Jersey, United States

Site Status

Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)

Commack, New York, United States

Site Status

Memoral Sloan Kettering Westchester (Consent only)

Harrison, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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15-117

Identifier Type: -

Identifier Source: org_study_id

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