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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02531672
• Other study ID #: 15-117
• Status: No longer available

Study information

• Verified date: June 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Recurrent Prostate Cancer

Intervention

Drug:
• 11C-choline

Device:
• PET/CT Scan

Locations

Country	Name	City	State
United States	Memoral Sloan Kettering Basking Ridge (Consent Only)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)	Commack	New York
United States	Memoral Sloan Kettering Westchester (Consent only)	Harrison	New York
United States	Memorial Sloan Kettering Bergen (Consent only )	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

External Links

•   Memorial Sloan Kettering Cancer Center