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

NCT ID: NCT00987376

Last Updated: 2016-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2009-09-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

Prostate cancer patients

Group Type: EXPERIMENTAL

Diagnostic Imaging: C11 choline PET; C11 acetate PET; and MRI Spectroscopy

Intervention Type: DEVICE

C11 Choline, C11 Acetate PET and MRI

Interventions

Diagnostic Imaging: C11 choline PET; C11 acetate PET; and MRI Spectroscopy

C11 Choline, C11 Acetate PET and MRI

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Val Lowe

Val J. Lowe, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mayo Clinic Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

CA91956-02

Identifier Type: -

Identifier Source: secondary_id

8-03

Identifier Type: -

Identifier Source: org_study_id