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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Sodium Acetate C11

• Registration Number: NCT01304485
• Lead Sponsor: Phoenix Molecular Imaging

Brief 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?

Study Timeline

• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Study Start: 2011-04
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 2000

Inclusion Criteria

• recurrent prostate cancer (detectable PSA following radical prostatectomy or rising PSA in patients with radiation therapy as the primary treatment)

Exclusion Criteria

• < 18 years old
• claustrophobic patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sodium Acetate C11 PET Imaging	Sodium Acetate C11	-

Primary Outcome Measures

Name	Time	Method
SUV (Standardized Uptake Value)	Day1 - Assessed at time of PET imaging - i.e. at the time of primary investigation/PET agent administration	Imaging studies will be evaluated both qualitatively and quantitatively using SUV (standardized uptake values): a measure of metabolism based on injected dose, patient weight and region of interest.

Secondary Outcome Measures

Name	Time	Method
PSA (prostate specific antigen)	Every 3 - 6 months for 24 months after PET imaging	PSA will be monitored per routine clinical follow-up.

Trial Locations

Locations (1)

Phoenix Molecular Imaging; 🇺🇸 Phoenix, Arizona, United States