Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
179 participants
INTERVENTIONAL
2003-07-31
2015-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Surgery - Negative PET scan
If patient is candidate for surgery with curative intent or staging lymphadenectomy, he will be enrolled in the study. If patient's PET scan is negative, the patient will receive the curative therapy and be followed for recurrence.
carbon-11 acetate PET scan
Surgery - Positive PET scan
If patient is candidate for surgery with curative intent or staging lymphadenectomy, he will be enrolled in the study. If patient's PET scan is positive, the patient will receive the curative therapy and be followed for recurrence or receive alternative therapy.
carbon-11 acetate PET scan
Radiation therapy Negative or Positive PET scan
If patient is candidate for radiation therapy with curative intent, he will be enrolled. If PET scan is negative he will receive curative therapy and be followed for PSA recurrence. If PET scan is positive he may receive confirmatory studies and then if negative, not indicated, or refused he will receive curative therapy be followed for PSA recurrence. If PET scan is positive and received positive confirmatory studies he will receive curative therapy and followed for recurrence.
carbon-11 acetate PET scan
Interventions
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carbon-11 acetate PET scan
Eligibility Criteria
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Inclusion Criteria
* 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
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Farrokh Dehdashti, MD
Role: STUDY_CHAIR
Washington University Siteman Cancer Center
Locations
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Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
Countries
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Other Identifiers
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