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

March 5, 2019 updated by: Fabio Almeida MD, Phoenix Molecular Imaging

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Actual)

2000

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85040
        • Phoenix Molecular Imaging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sodium Acetate C11 PET Imaging
Drug: Sodium Acetate C11
PET Imaging with Sodium Acetate C11
Other Names:
  • AC-PET
  • Carbon 11 Acetate PET
  • C11 Acetate

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phoenix Molecular Imaging

Investigators

  • Principal Investigator: Fabio Almeida, M.D., Medical Director, Phoenix Molecular Imaging

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

February 24, 2011

First Posted (Estimate)

February 25, 2011

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMIC-AC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Journal Publication

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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