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

Wake Forest University (WFU)

Status and phase

Completed

Phase 1

Conditions

Prostate Cancer

Treatments

Procedure: needle biopsy

Drug: PET-CT scans supplemented with 11C-Choline tracer

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00804245

P30CA012197 (U.S. NIH Grant/Contract)

CCCWFU-85207

IRB00005483

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

Male

Ages

30 to 120 years old

Volunteers

No 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