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

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ClinicalTrials.gov Identifier: NCT01530269
Recruitment Status : Recruiting
First Posted : February 9, 2012
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Fabio Almeida MD, Phoenix Molecular Imaging

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Adenocarcinoma Drug: C11-Sodium Acetate Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma
Study Start Date : April 2012
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Tissue Biopsy of metastatic site(s) [ Time Frame: Assessed within 30 days following AC-PET ]
    Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT


Secondary Outcome Measures :
  1. PSA (prostate specific antigen) [ Time Frame: Each 3 - 6 months for 24 months ]
    PSA (prostate specific antigen) will be monitored per routine clinical follow-up



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530269


Contacts
Contact: Fabio Almeida, MD 520-661-5125 falmeida@phxmi.com
Contact: Elisa Blackwell, CRC eblackwell@phxmi.com

Locations
United States, Arizona
Phoenix Molecular Imaging Recruiting
Phoenix, Arizona, United States, 85040
Contact: Fabio Almeida, MD    520-661-5125    falmeida@phxmi.com   
Principal Investigator: Fabio Almeida, MD         
Sponsors and Collaborators
Phoenix Molecular Imaging
Investigators
Principal Investigator: Fabio Almeida, MD Medical Director, Phoenix Molecular Imaging

Responsible Party: Fabio Almeida MD, Medical Director and Principal Investigator, Phoenix Molecular Imaging
ClinicalTrials.gov Identifier: NCT01530269     History of Changes
Other Study ID Numbers: AMIC-AC-002
First Posted: February 9, 2012    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fabio Almeida MD, Phoenix Molecular Imaging:
intermediate
high
risk
radiation
therapy
planning
surgical
immunotherapy
chemotherapy
hormone

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