Novel PET/CT Agents and MRS/MRI in Prostate CA and High Risk Prostate Cancer: An Inter-SPORE Collaboration

Phase 1

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00987376
• Lead Sponsor: Mayo Clinic

Brief Summary

Prostate cancer imaging using traditional anatomic modalities including CT, MR, and ultrasound is limited. Improvement in current imaging modalities or development of new ones should be a priority in prostate cancer research. Optimal treatment varies considerably for patients with different staging characterizations and new imaging methods that more accurately stage patients could lead to more appropriate treatment. The objective of this study is to obtain preliminary, comparative data on new, promising imaging methods for prostate cancer. PET/CT imaging using 11C-choline,11C-acetate, and Y86 or 18F-Adenosylcobalamin and MRI spectroscopy (MRS) of prostate cancer will be compared. Direct comparison of these imaging methods has never been done and Mayo Clinic and Johns Hopkins are uniquely able to conduct such a trial as an inter-SPORE collaboration.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2007-12-20
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• Males 18 years of age or older
• Patients who have completed staging CT and/or bone scan as part of their routine workup
• Patients with bulky metastatic prostate cancer who have 5 or more lesions suspicious for distant metastases as determined by routine CT and/or bone scans that are untreated by radiation

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Exclusion Criteria

• Patients who are less than 6 weeks post operative for Greenfield filter placement
• Patients with metallic surgical implants including pacemaker implants, cochlear implants, dentures held in place by magnets imbedded in the gums and aneurysm clips except those inserted at Mayo and only those inserted after October of 1994 and /or metal fragments in the body including metal fragments in the eyes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Test accuracy	2 years

Secondary Outcome Measures

Name	Time	Method
Test comparative accuracy of PET and MRI	2years

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States