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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00804245

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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

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.

Study Design

Study Type:

Interventional

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 :

Aug 1, 2008

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 120 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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