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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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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) and with that of CT?

3. What is the optimal imaging protocol in terms of imaging time after injection?


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

SUV (Standardized Uptake Value)

Outcome Description:

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.

Outcome Time Frame:

Day1 - Assessed at time of PET imaging - i.e. at the time of primary investigation/PET agent administration

Safety Issue:

No

Principal Investigator

Fabio Almeida, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical Director, Arizona Molecular Imaging Center

Authority:

United States: Food and Drug Administration

Study ID:

AMIC-AC-001

NCT ID:

NCT01304485

Start Date:

April 2011

Completion Date:

April 2014

Related Keywords:

  • Prostate Cancer
  • Recurrent Prostate Carcinoma
  • sodium acetate c11
  • PET
  • prostate cancer
  • rising PSA
  • PSA recurrence
  • biochemical recurrence
  • Carcinoma
  • Prostatic Neoplasms

Name

Location
Arizona Molecular Imaging Center Phoenix, Arizona  85040