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C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma

Primary Purpose

Prostate Cancer, Prostate Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
C11-Sodium Acetate
Sponsored by
Phoenix Molecular Imaging
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring intermediate, high, risk, radiation, therapy, planning, surgical, immunotherapy, chemotherapy, hormone

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Male patients will be studied who have prostate cancer:

  • Diagnosed with prostate adenocarcinoma
  • Has completed conventional staging examinations, including histologic evaluation with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy Candidate for curative prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery

  • Deemed to be at intermediate or high risk for recurrence or metastatic disease after initial curative treatment, as defined by of one of the following:

    • Gleason score >= 7 or PSA >= 10
    • Gleason score < 7 or PSA <10 ng/mL with positive surgical margins, biopsy proven or suspected regional nodal involvement or conventional imaging showing limited metastatic disease that may be amenable to directed radiotherapy
    • Rising or non-responding PSA

Exclusion Criteria:

  • < 18 years old
  • claustrophobic patients

Sites / Locations

  • Phoenix Molecular Imaging

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET/CT imaging with C11-Sodium Acetate

Arm Description

Outcomes

Primary Outcome Measures

Tissue Biopsy of metastatic site(s)
Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT

Secondary Outcome Measures

PSA (prostate specific antigen)
PSA (prostate specific antigen) will be monitored per routine clinical follow-up

Full Information

First Posted
February 4, 2012
Last Updated
March 5, 2019
Sponsor
Phoenix Molecular Imaging
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1. Study Identification

Unique Protocol Identification Number
NCT01530269
Brief Title
C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma
Official Title
C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Phoenix Molecular Imaging

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Positron emission tomography using carbon-11 acetate (AC-PET) may help find local or distant metastases from prostate cancer. This clinical trial is studying how this imaging test may help influence the choice and extent of initial treatments, and subsequent treatments.
Detailed Description
OBJECTIVES: Determine the role of positron emission tomography using carbon-11 acetate (AC-PET) in the initial and subsequent management of patients with prostate cancer at intermediate or high risk for recurrence after initial curative therapy. Compare the value of AC-PET in predicting recurrence of prostate cancer with that of conventional approaches (e.g., pre-operative clinical staging, prostate-specific antigen, Gleason score, prostate and lymph node histology) in these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Adenocarcinoma
Keywords
intermediate, high, risk, radiation, therapy, planning, surgical, immunotherapy, chemotherapy, hormone

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET/CT imaging with C11-Sodium Acetate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
C11-Sodium Acetate
Other Intervention Name(s)
C11 Acetate PET, Carbon 11, AC-PET
Intervention Description
PET Imaging with C11-Sodium Acetate
Primary Outcome Measure Information:
Title
Tissue Biopsy of metastatic site(s)
Description
Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT
Time Frame
Assessed within 30 days following AC-PET
Secondary Outcome Measure Information:
Title
PSA (prostate specific antigen)
Description
PSA (prostate specific antigen) will be monitored per routine clinical follow-up
Time Frame
Each 3 - 6 months for 24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male patients will be studied who have prostate cancer: Diagnosed with prostate adenocarcinoma Has completed conventional staging examinations, including histologic evaluation with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy Candidate for curative prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery Deemed to be at intermediate or high risk for recurrence or metastatic disease after initial curative treatment, as defined by of one of the following: Gleason score >= 7 or PSA >= 10 Gleason score < 7 or PSA <10 ng/mL with positive surgical margins, biopsy proven or suspected regional nodal involvement or conventional imaging showing limited metastatic disease that may be amenable to directed radiotherapy Rising or non-responding PSA Exclusion Criteria: < 18 years old claustrophobic patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Almeida, MD
Organizational Affiliation
Medical Director, Phoenix Molecular Imaging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Molecular Imaging
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85040
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma

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