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

Phoenix Molecular Imaging

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Sodium Acetate C11

Study type: Interventional

Funder types: Other

Identifiers

NCT01304485

AMIC-AC-001

Details and patient eligibility

About

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

Full 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?

Enrollment: 2,000 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,000 participants in 1 patient group

Sodium Acetate C11 PET Imaging

Experimental group

Treatment:

Drug: Sodium Acetate C11