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

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

Detailed Description
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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: What is the yield of current state-of-the-art PET/CT with C-11 Acetate in detecting recurrent disease in this patient population? 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? What is the optimal imaging protocol in terms of imaging time after injection?

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Sodium Acetate C11


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium Acetate C11 PET Imaging<br> | Drug: Sodium Acetate C11<br>* PET Imaging with Sodium Acetate C11<br>* Other names: AC-PET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUV (Standardized Uptake Value) | 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. | Day1 - Assessed at time of PET imaging - i.e. at the time of primary investigation/PET agent administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA (prostate specific antigen) | PSA will be monitored per routine clinical follow-up. | Every 3 - 6 months for 24 months after PET imaging | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent Prostate Carcinoma, sodium acetate c11, PET, prostate cancer, rising PSA, PSA recurrence, biochemical recurrence