Detecting Recurrent Prostate Cancer With 11C-choline Positron Emission Tomography
Primary Purpose
Prostate Cancer, Recurrent Prostate Cancer
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
11C-choline
PET/CT Scan
Sponsored by
About this trial
This is an expanded access trial for Prostate Cancer focused on measuring 11C-choline, Positron Emission Tomography, 15-117
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.
Exclusion Criteria:
- Patient must not have claustrophobia that would preclude PET/CT imaging or other contraindications to CT imaging.
Sites / Locations
- Memoral Sloan Kettering Basking Ridge (Consent Only)
- Memorial Sloan Kettering Bergen (Consent only )
- Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
- Memoral Sloan Kettering Westchester (Consent only)
- Memorial Sloan Kettering Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02531672
First Posted
August 20, 2015
Last Updated
June 4, 2020
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02531672
Brief Title
Detecting Recurrent Prostate Cancer With 11C-choline Positron Emission Tomography
Official Title
Detecting Recurrent Prostate Cancer With 11C-choline Positron Emission Tomography: An Expanded Access Study
Study Type
Expanded Access
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Recurrent Prostate Cancer
Keywords
11C-choline, Positron Emission Tomography, 15-117
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
11C-choline
Intervention Type
Device
Intervention Name(s)
PET/CT Scan
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Exclusion Criteria:
Patient must not have claustrophobia that would preclude PET/CT imaging or other contraindications to CT imaging.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heiko Schӧder, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memoral Sloan Kettering Basking Ridge (Consent Only)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Bergen (Consent only )
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memoral Sloan Kettering Westchester (Consent only)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
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Detecting Recurrent Prostate Cancer With 11C-choline Positron Emission Tomography
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