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C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00804245
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : July 3, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: needle biopsy Drug: PET-CT scans supplemented with 11C-Choline tracer Phase 1

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : August 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: radiolabeled choline tracer scans
PET-CT scans supplemented with Choline 11 tracer
Procedure: needle biopsy
Biopsy of positive findings found on CT scan

Drug: PET-CT scans supplemented with 11C-Choline tracer
Use of 11C-Choline tracer to enhance diagnostic utility of 11C-Choline tracer

Primary Outcome Measures :
  1. Determination of utility of 11C-Choline in enhancing efficacy of Pet-CT scans [ Time Frame: Approximately 1 year ]
    To determine the differential usefulness 11C-Choline during PET-CT to enhance diagnostic capability in evaluating metastatic disease.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria:

  • Other cancer within the past 5 years (except for nonmelanoma skin cancer)
  • No prior radiotherapy, hormonal therapy, surgery (other than biopsy), or cryotherapy for prostate cancer Prior transurethral resection of the prostate allowed

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 identifier (NCT number): NCT00804245

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United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
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Study Chair: Pradeep Garg, PhD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences Identifier: NCT00804245    
Other Study ID Numbers: IRB00005483
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents