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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.
See Contacts and Locations
Verified April 2017 by Fabio Almeida MD, Phoenix Molecular Imaging
Sponsor:
Information provided by (Responsible Party):
Fabio Almeida MD, Phoenix Molecular Imaging
ClinicalTrials.gov Identifier:
NCT01530269
First received: February 4, 2012
Last updated: April 3, 2017
Last verified: April 2017
February 4, 2012
April 3, 2017
April 2012
April 2018   (Final data collection date for primary outcome measure)
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
Post Imaging Referring Physician Questionaire [ Time Frame: Assessed within 30 days following AC-PET ]
To assess the effect of AC-PET on referring physicians' plans of intended patient management of patients with prostate cancer.
Complete list of historical versions of study NCT01530269 on ClinicalTrials.gov Archive Site
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
PSA (prostate specific antigen) [ Time Frame: Each 3 - 6 months for 24 months ]
PSA will be monitored per routine clincal follow-up
Not Provided
Not Provided
 
C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma
C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma
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.

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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Prostate Cancer
  • Prostate Adenocarcinoma
Drug: C11-Sodium Acetate
PET Imaging with C11-Sodium Acetate
Other Names:
  • C11 Acetate PET
  • Carbon 11
  • AC-PET
Experimental: PET/CT imaging with C11-Sodium Acetate
Intervention: Drug: C11-Sodium Acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
April 2019
April 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 90 Years   (Adult, Senior)
No
Contact: Fabio Almeida, MD 520-661-5125 falmeida@phxmi.com
Contact: Elisa Blackwell, CRC eblackwell@phxmi.com
United States
 
 
NCT01530269
AMIC-AC-002
No
Not Provided
Plan to Share IPD: No
Fabio Almeida MD, Phoenix Molecular Imaging
Phoenix Molecular Imaging
Not Provided
Principal Investigator: Fabio Almeida, MD Medical Director, Phoenix Molecular Imaging
Phoenix Molecular Imaging
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP