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C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer
This study is currently recruiting participants.
Study NCT00804245   Information provided by National Cancer Institute (NCI)
First Received: December 5, 2008   Last Updated: June 9, 2009   History of Changes

December 5, 2008
June 9, 2009
August 2008
February 2010   (final data collection date for primary outcome measure)
Sensitivity and specificity of PET-CT scan using C-11 choline in detecting bone and lymph node metastases [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00804245 on ClinicalTrials.gov Archive Site
  • Semi-quantitative analysis of tracer uptake using standard uptake values and qualitative analysis using pure visual analysis [ Designated as safety issue: No ]
  • Development of an algorithm that includes the routine use of C-11 choline PET-CT scan for the staging of prostate cancer [ Designated as safety issue: No ]
  • Correlation of C-11 choline PET-CT scan positivity with biochemical relapse-free survival, time to development of clinically apparent metastases, time to local failure, and overall survival [ Designated as safety issue: No ]
Same as current
 
C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer
A Pilot Study of Use of 11C-Choline PET-CT in the Metastatic Evaluation of Patients With Newly Diagnosed High Risk Adenocarcinoma of the Prostate

RATIONALE: New diagnostic procedures, such as C-11 choline PET-CT scan, may be effective in finding cancer that has spread to the bone and lymph nodes in patients with prostate cancer.

PURPOSE: This clinical trial is studying how well C-11 choline PET-CT scan works in finding metastases in patients with newly diagnosed high-risk prostate cancer.

OBJECTIVES:

Primary

  • To determine the sensitivity and specificity of PET-CT scan using C-11 choline in detecting bone and lymph node metastases in patients with newly diagnosed high-risk adenocarcinoma of the prostate.

Secondary

  • To perform semi-quantitative analysis of tracer uptake using standard uptake values and qualitative analysis using pure visual analysis.
  • To develop an algorithm that includes the routine use of C-11 choline PET-CT scan for the staging of patients with prostate cancer at high risk of metastatic disease.
  • To determine whether the presence of C-11 choline PET-CT scan positivity in these patients is predictive of outcomes, including biochemical relapse-free survival, time to development of clinically apparent metastases, time to local failure, and overall survival.
  • To obtain tissue specimens from these patients for correlative studies and further evaluation.
  • To obtain information regarding the feasibility and characteristics of C-11 choline PET-CT scan after androgen suppression.

OUTLINE: Patients undergo CT scan of the abdomen and pelvis with IV contrast and a bone scan. Patients also undergo a C-11 choline PET-CT scan*. In the case of any positive scan, patients undergo a needle biopsy. If the biopsy is negative for metastatic disease or if the biopsy is positive for metastatic disease in a draining lymph node region, patients receive radiotherapy and hormonal (antiandrogen) therapy. If the biopsy is positive for metastatic disease at any other site, patients receive hormonal therapy alone.

NOTE: *The first 10 patients enrolled on the study who have a positive PET-CT scan and positive biopsy undergo a second PET-CT scan at 6 months after the initial PET-CT scan.

Patients are followed every 3 months for 1 year and then every 6 months for 1 year.

 
Interventional
Diagnostic
Prostate Cancer
  • Dietary Supplement: C-11 choline
  • Procedure: bone scan
  • Procedure: computed tomography
  • Procedure: needle biopsy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
78
 
February 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Prior negative prostate biopsy allowed
  • High-risk disease, as defined by one of the following:

    • PSA ≥ 20 ng/mL
    • Gleason score ≥ 8
    • Digital rectal examination revealing ≥ T2c disease (tumor involving more than one half of one lobe of the prostate)

PATIENT CHARACTERISTICS:

  • Creatinine < 2.0 mg/dL
  • Able to tolerate PET scan, CT scan, and bone scan
  • Able to tolerate IV and oral contrast
  • Willing to undergo biopsy of positive findings on PET-CT scan, CT scan, or bone scan
  • No other cancer within the past 5 years except for nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy, hormonal therapy, surgery (other than biopsy), or cryotherapy for prostate cancer
  • Prior transurethral resection of the prostate allowed
Male
30 Years and older
No
 
United States
 
NCT00804245
Pradeep Garg, Wake Forest University Comprehensive Cancer Center
CDR0000627716, CCCWFU-85207
Wake Forest University
National Cancer Institute (NCI)
Study Chair: Pradeep Garg, PhD Wake Forest University
Investigator: Daniel Fried, MD Wake Forest University
National Cancer Institute (NCI)
June 2009

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