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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

Phase 1
30 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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



- 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

- To obtain tissue specimens from these patients for correlative studies and further

- 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.

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Determination of utility of 11C-Choline in enhancing efficacy of Pet-CT scans

Outcome Description:

To determine the differential usefulness 11C-Choline during PET-CT to enhance diagnostic capability in evaluating metastatic disease.

Outcome Time Frame:

Approximately 1 year

Safety Issue:


Principal Investigator

Pradeep Garg, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Food and Drug Administration

Study ID:




Start Date:

August 2008

Completion Date:

December 2015

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Adenocarcinoma
  • Prostatic Neoplasms



Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096