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

NCT ID: NCT00804245

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2013-08-31

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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

radiolabeled choline tracer scans

PET-CT scans supplemented with Choline 11 tracer

Group Type: EXPERIMENTAL

needle biopsy

Intervention Type: PROCEDURE

Biopsy of positive findings found on CT scan

PET-CT scans supplemented with 11C-Choline tracer

Intervention Type: DRUG

Use of 11C-Choline tracer to enhance diagnostic utility of 11C-Choline tracer

Interventions

needle biopsy

Biopsy of positive findings found on CT scan

Intervention Type: PROCEDURE

PET-CT scans supplemented with 11C-Choline tracer

Use of 11C-Choline tracer to enhance diagnostic utility of 11C-Choline tracer

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pradeep Garg, PhD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CCCWFU-85207

Identifier Type: -

Identifier Source: secondary_id

IRB00005483

Identifier Type: -

Identifier Source: org_study_id