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

Prostate Cancer Clinical Trial

Official title:

Comparison of Novel PET/CT Imaging Agents and MRS/MRI in Metastatic and High Risk Prostate Cancer: An Inter-SPORE Collaboration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987376
• Other study ID #: 8-03
• Secondary ID: CA91956-02
• Status: Completed
• Phase: Phase 1
• First received: December 20, 2007
• Last updated: January 12, 2016
• Start date: November 2003
• Est. completion date: September 2009

Study information

• Verified date: January 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Diagnostic Imaging: C11 choline PET; C11 acetate PET; and MRI Spectroscopy
C11 Choline, C11 Acetate PET and MRI

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test accuracy		2 years	No
Secondary	Test comparative accuracy of PET and MRI		2years	No