c-11 choline pet-ct scan in finding metastases in patients with newly diagnosed high-risk prostate cancer

Conditions: Prostate Cancer

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.

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

Keywords: adenocarcinoma of the prostate stage i prostate cancer stage ii prostate cancer stage iii prostate cancer stage iv prostate cancer