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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA101734 | U.S. NIH Grant/Contract | View source | |
| P30CA091842 | U.S. NIH Grant/Contract | View source | |
| WU-03-0315 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery - Negative PET scan | Active Comparator | 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. |
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| Surgery - Positive PET scan | Experimental | 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. |
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| Radiation therapy Negative or Positive PET scan | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbon-11 acetate PET scan | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Determine the role of AC-PET in changing initial patient management | Completion of patient treatment |
| Measure | Description | 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 |
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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:
Exclusion Therapy:
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| Name | Affiliation | Role |
|---|---|---|
| Farrokh Dehdashti, MD | Washington University Siteman Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |