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

This study is currently recruiting participants.
Verified December 2012 by Arizona Molecular Imaging Center
Sponsor:
Information provided by (Responsible Party):
Fabio Almeida MD, Arizona Molecular Imaging Center
ClinicalTrials.gov Identifier:
NCT01530269
First received: February 4, 2012
Last updated: December 1, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Arizona Molecular Imaging Center:

Primary Outcome Measures:
  • Tissue Biopsy of metastatic site(s) [ Time Frame: Assessed within 30 days following AC-PET ] [ Designated as safety issue: No ]
    Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT


Secondary Outcome Measures:
  • PSA (prostate specific antigen) [ Time Frame: Each 3 - 6 months for 24 months ] [ Designated as safety issue: No ]
    PSA (prostate specific antigen) will be monitored per routine clinical follow-up


Estimated Enrollment: 300
Study Start Date: April 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PET/CT imaging with C11-Sodium Acetate Drug: C11-Sodium Acetate
PET Imaging with C11-Sodium Acetate
Other Names:
  • C11 Acetate PET
  • Carbon 11
  • AC-PET

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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530269

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
Contact: Fabio Almeida, MD     602-331-1771     falmeida@healthwestpartners.net    
Principal Investigator: Fabio Almeida, MD            
Sponsors and Collaborators
Arizona Molecular Imaging Center
Investigators
Principal Investigator: Fabio Almeida, MD Medical Director, Arizona Molecular Imaging Center
  More Information

No publications provided

Responsible Party: Fabio Almeida MD, Medical Director and Principal Investigator, Arizona Molecular Imaging Center
ClinicalTrials.gov Identifier: NCT01530269     History of Changes
Other Study ID Numbers: AMIC-AC-002
Study First Received: February 4, 2012
Last Updated: December 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Arizona Molecular Imaging Center:
intermediate
high
risk
radiation
therapy
 planning
surgical
immunotherapy
chemotherapy
hormone

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Prostatic Neoplasms
Neoplasm Metastasis
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Cystic, Mucinous, and Serous
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013