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

NCT02355054 | Unknown

• 1 other identifier: 201411142
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to provide clinical access to PET/CT and PET/MRI with C-11 choline for evaluation of men with biochemically recurrent prostate cancer while awaiting approval of the Washington University Abbreviated New Drug Application for C-11 choline.

Conditions

Cancer of the Prostate

Keywords

Recurrent

Interventions

C-11 Choline PET Imaging DRUG

Patients will receive IV injection of C-11 Choline followed by imaging from the base of the brain to the upper thigh on a PET/CT or a PET/MRI scanner

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)

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 ≥ 2.0 ng/mL above the post therapy nadir for patients treated with radiation therapy, brachytherapy or cryotherapy.
• PSA ≥ 2.0 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. Standard staging examinations may include one or more of the following: CT or MRI, bone imaging (either Tc-99m bisphosphonate scintigraphy or F-18 sodium fluoride PET), OR In-111 capromab pendetide scintigraphy.
• Age \> 18 years.
• Patient must be able to tolerate PET/MRI or PET/CT imaging
• Patient must be able to understand and willing to sign a written informed consent document.
• Patient must be able to understand and willing to sign an Advance Beneficiary Notice (ABN) (Medicare patient) or a Notice of Non-coverage (NNC) from (non-Medicare patient) that addresses the potential cost to the patient of C-11 choline PET/CT or PET/MRI.

You may not qualify if:

• For patients planned to have PET/MRI:
• Patient must not have claustrophobia or any other contraindication to MRI as evaluated by a standardized MRI safety questionnaire.
• If applicable, patient must not have renal insufficiency (estimated glomerular filtration rate \< 30 mL/min/1.73 m2 based on measurement within the past 60 days) or be undergoing dialysis as these conditions preclude safe administration of MRI contrast agents. NOTE: At the discretion of principal investigator, a subject may be allowed to enroll/continue on study and undergo imaging without the administration of contrast in the event of renal insufficiency.
• If applicable, patient must not have a known prior reaction to gadolinium based MRI contrast agents.
• For patients planned to have PET/CT:
• Patient must not have claustrophobia that would preclude PET/CT imaging or other contraindications to CT imaging.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine, Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 4, 2015
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

US (1)