Prostate Cancer
Conditions
Keywords
stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
Brief summary
RATIONALE: Diagnostic procedures, such as positron emission tomography using carbon-11 acetate, may help find metastases from prostate cancer and may help predict whether prostate cancer will come back after treatment. PURPOSE: This clinical trial is studying how well positron emission tomography using carbon-11 acetate works in finding metastases and predicting recurrence in patients with prostate cancer who are at risk for recurrence after treatment.
Detailed description
The overall goal of this project is determination of the role of PET in patients with newly diagnosed medium- and high-risk prostate cancer in whom the standard clinical and imaging workup is negative. Thus, the incremental value of PET will be determined in this important group.
Interventions
PROCEDUREcarbon-11 acetate PET scan
Sponsors
National Cancer Institute (NCI)
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed prostate cancer * Has completed conventional staging examinations, including biopsy with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy AND conventional staging examinations negative * Candidate for curative radical prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery * Deemed to be at medium or high risk for recurrence after initial curative treatment, as defined by 1 of the following criteria: * Gleason score 7 AND prostate-specific antigen (PSA) 10-20 ng/mL * Gleason score ≥ 8 AND PSA \< 10 ng/mL * Gleason score ≥ 8 AND PSA \> 10 ng/mL * Any Gleason score AND PSA \> 20 ng/mL Exclusion Therapy: * Not a candidate for treatment by surgery or radiation therapy with curative intent * Inability to give informed consent * Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the role of AC-PET in changing initial patient management | Completion of patient treatment |
Secondary
| Measure | Time frame |
|---|---|
| Determine the value of AC-PET in predicting recurrence | Minimum of 2 years and maximum of 5 years |
| Assess the performance of AC-PET for detection of lymph node metastasis by comparison with biopsy. | Minimum of 2 years and maximum of 5 years |
Countries
United States
Outcome results
None listed