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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804245
• Other study ID #: IRB00005483
• Secondary ID: P30CA012197CCCWF
• Status: Completed
• Phase: Phase 1
• Start date: August 2008
• Est. completion date: August 2013

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of utility of 11C-Choline in enhancing efficacy of Pet-CT scans	To determine the differential usefulness 11C-Choline during PET-CT to enhance diagnostic capability in evaluating metastatic disease.	Approximately 1 year