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

NCT00987376 | Completed Phase 1 DMC

• 2 other identifiers: 8-03CA91956-02
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Test accuracy

  2 years

Secondary Outcomes (1)

• Test comparative accuracy of PET and MRI

  2years

Study Arms (1)

1

EXPERIMENTAL

Prostate cancer patients

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

Interventions

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

C11 Choline, C11 Acetate PET and MRI

1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Val J. Lowe, MD

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: September 30, 2009
• Study Start: November 1, 2003
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 13, 2016

Record last verified: 2016-01

Locations

US (1)