Clinical trial NCT00804245: C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-12-08
Enrollment: 18
Sex: MALE
Minimum age (years): 30
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Determination of utility of 11C-Choline in enhancing efficacy of Pet-CT scans
timeFrame: Approximately 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Pradeep Garg, PhD
role: STUDY_CHAIR
References: