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

This study is currently recruiting participants.
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Verified February 2017 by Fabio Almeida MD, Phoenix Molecular Imaging
Information provided by (Responsible Party):
Fabio Almeida MD, Phoenix Molecular Imaging Identifier:
First received: February 24, 2011
Last updated: February 22, 2017
Last verified: February 2017
Positron emission tomography (PET) imaging evaluation in men with recurrent prostate cancer to select patients who may benefit from directed therapy

Condition Intervention Phase
Prostate Cancer Drug: Sodium Acetate C11 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Phase 2 Study: PET Imaging Characteristics of C11-Acetate in Patients With Prostate Carcinoma, Detection of Recurrent Disease With PSA Relapse

Resource links provided by NLM:

Further study details as provided by Fabio Almeida MD, Phoenix Molecular Imaging:

Primary Outcome Measures:
  • SUV (Standardized Uptake Value) [ Time Frame: 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:
  • PSA (prostate specific antigen) [ Time Frame: Every 3 - 6 months for 24 months after PET imaging ]
    PSA will be monitored per routine clinical follow-up.

Estimated Enrollment: 1500
Study Start Date: April 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium Acetate C11 PET Imaging Drug: Sodium Acetate C11
PET Imaging with Sodium Acetate C11
Other Names:
  • Carbon 11 Acetate PET
  • C11 Acetate
  • AC-PET

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?

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01304485

Contact: Fabio Almeida, MD 520-661-5125
Contact: Elisa Blackwell, CRC

United States, Arizona
Phoenix Molecular Imaging Recruiting
Phoenix, Arizona, United States, 85040
Principal Investigator: Fabio Almeida, MD         
Sponsors and Collaborators
Phoenix Molecular Imaging
Principal Investigator: Fabio Almeida, M.D. Medical Director, Phoenix Molecular Imaging
  More Information

Responsible Party: Fabio Almeida MD, Fabio Almeida MD, Medical Director, Phoenix Molecular Imaging Identifier: NCT01304485     History of Changes
Other Study ID Numbers: AMIC-AC-001
Study First Received: February 24, 2011
Last Updated: February 22, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Journal Publication

Keywords provided by Fabio Almeida MD, Phoenix Molecular Imaging:
Recurrent Prostate Carcinoma
sodium acetate c11
prostate cancer
rising PSA
PSA recurrence
biochemical recurrence

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on August 16, 2017