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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Arizona Molecular Imaging Center
Sponsor:
Information provided by (Responsible Party):
Fabio Almeida MD, Arizona Molecular Imaging Center
ClinicalTrials.gov Identifier:
NCT01304485
First received: February 24, 2011
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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: Open Label
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 Arizona Molecular Imaging Center:

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    PSA will be monitored per routine clinical follow-up.


Estimated Enrollment: 500
Study Start Date: April 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2015 (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?
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01304485

Contacts
Contact: Fabio Almeida, MD 602.331.1771 falmeida@healthwestpartners.net
Contact: Elisa Blackwell, CPC 602.331.1771 eblackwell@healthwestpartners.net

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

No publications provided

Responsible Party: Fabio Almeida MD, Fabio Almeida MD, Medical Director, Arizona Molecular Imaging Center
ClinicalTrials.gov Identifier: NCT01304485     History of Changes
Other Study ID Numbers: AMIC-AC-001
Study First Received: February 24, 2011
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Arizona Molecular Imaging Center:
Recurrent Prostate Carcinoma
sodium acetate c11
PET
prostate cancer
rising PSA
PSA recurrence
biochemical recurrence

Additional relevant MeSH terms:
Carcinoma
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014