NCT01304485

PET Imaging Characteristics of C11-Acetate in Patients With Recurrent Prostate Carcinoma

Phase 2 Study: PET Imaging Characteristics of C11-Acetate in Patients With Prostate Carcinoma, Detection of Recurrent Disease With PSA Relapse

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2,000 (actual)
• Sponsor: Phoenix Molecular Imaging · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Positron emission tomography (PET) imaging evaluation in men with recurrent prostate cancer to select patients who may benefit from directed therapy

Detailed description

The goal of this project is improved imaging of prostate cancer by positron emission tomography (PET) with use of the radiopharmaceutical C-11 Acetate, utilizing state-of-the-art PET/CT camera technology and processing algorithms. A successful effort will lead to more accurate diagnosis of recurrence in patients with prostate cancer to allow for early directed therapy. This study is designed to generate data to add to the understanding of the effectiveness of C-11 Acetate, focusing on patients with recurrent or persistent disease after prostatectomy or radiation therapy. The study is designed to expand on the database of C11-Acetate PET imaging in patients with prior definitive therapy for prostate cancer and evidence of biochemical recurrence (post therapy rise in PSA), and to evaluate the relationship between detection on C11-Acetate PET imaging, PSA (Trigger, Velocity and Doubling Time) and FDG PET imaging. Specific questions to be addressed: 1. What is the yield of current state-of-the-art PET/CT with C-11 Acetate in detecting recurrent disease in this patient population? 2. How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose (FDG-PET), Sodium F18 PET bone scans and with that of CT? 3. What is the optimal imaging protocol in terms of imaging time after injection?

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Sodium Acetate C11	PET Imaging with Sodium Acetate C11

Timeline

• Start date: 2011-04-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2011-02-25
• Last updated: 2019-03-07

Locations

1 site across 1 country: United States