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

Sponsor:	Comprehensive Cancer Center of Wake Forest University
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:	NCT00804245

Purpose

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	Intervention
Prostate Cancer	Procedure: needle biopsy Drug: PET-CT scans supplemented with 11C-Choline tracer

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Nuclear Scans Prostate Cancer

Drug Information available for: Choline Choline chloride Choline dihydrogen citrate Choline bitartrate Choline salicylate

U.S. FDA Resources

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:

Determination of utility of 11C-Choline in enhancing efficacy of Pet-CT scans [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
To determine the differential usefulness 11C-Choline during PET-CT to enhance diagnostic capability in evaluating metastatic disease.

Estimated Enrollment:	78
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804245

Locations

United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096

Sponsors and Collaborators

Comprehensive Cancer Center of Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:

Pradeep Garg, PhD

Comprehensive Cancer Center of Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:	NCT00804245 History of Changes
Other Study ID Numbers:	CDR0000627716, P30CA012197, CCCWFU-85207
Study First Received:	December 5, 2008
Last Updated:	January 10, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Comprehensive Cancer Center of Wake Forest University:

adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:

Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012