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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HS019356-01 | U.S. AHRQ Grant/Contract | View source | |
| CE grant | Other Identifier | PCORI | |
| 1R01HS022640-01 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Agency for Healthcare Research and Quality (AHRQ) | FED |
| Louisiana State University Health Sciences Center in New Orleans | OTHER |
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This study will primarily compare the effectiveness of surgery and radiation for localized prostate cancer, the most common male cancer. It will focus on modern technologies and control for differences in patients and treatments that may affect both cancer-related and patient-reported outcomes (such as impotence and incontinence). By figuring out what treatments "work best, in which patients and in whose hands", it will help men with prostate cancer make better decisions regarding their care.
Prostate cancer is the most common solid tumor and the second leading cause of cancer death among American men. While surgery, radiation and observation have all been deemed appropriate for newly diagnosed men, tremendous uncertainty remains regarding the optimal treatment. AHRQ's 2008 evidence report on the comparative effectiveness of therapies for localized prostate cancer concluded that "no one therapy can be considered the preferred treatment for localized prostate cancer due to the limitations in the body of evidence as well as the likely tradeoffs an individual patient must make between estimated treatment effectiveness, necessity and adverse effects." The existing literature is limited by its focus on older therapeutic modalities and failure to control for individual patient characteristics and provider/hospital characteristics that may influence outcomes (quality of care). To fill these evidence gaps, we propose to expand a network of state tumor registries and a national observational disease registry to establish a new population-based cohort of men newly diagnosed with localized prostate cancer. We will prospectively measure key patient-reported outcomes, such as health-related quality of life and side-effects of therapy at diagnosis and 6 and 12 months later. We will also collect detailed medical record information, including clinical data, technical details of the interventions, complications, short-term cancer recurrence rates, and quality-of-care indicators.
By using this approach, we will overcome limitations of the extant literature and achieve the following specific aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Radical Prostatectomy | 262 | ||
| Robotic Radical Prostatectomy | 1303 | ||
| Intensity-Modulated Radiotherapy | 638 | ||
| Interstitial Brachytherapy | 171 | ||
| combined EBRT and Brachytherapy | 143 | ||
| Active Surveillance | 448 | ||
| Various other treatments | 300 |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease-Specific Health-Related Quality of Life (EPIC) | Sexual, urinary, bowel and hormonal function and bother subscores will be assessed | 12, 24 and 60 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| cancer-free survival | assessed using PSA levels obtained from medical record review | 6 and 12 months after enrollment |
| Complications of treatment | data collected from patient report and medical record review |
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Inclusion Criteria:
Exclusion Criteria:
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Population-based sample of men diagnosed with localized prostate cancer in the states of Louisiana and New Jersey and the metropolitan areas of Atlanta and Los Angeles, augmented with a convenience sample of men enrolled in the CaPSURE database, a national observational disease registry.
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| Name | Affiliation | Role |
|---|---|---|
| David F Penson, MD, MPH | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| University of California, San Francisco |
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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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| University of California, Irvine | OTHER |
| University of California, San Francisco | OTHER |
| University of Southern California | OTHER |
| M.D. Anderson Cancer Center | OTHER |
| University of Utah | OTHER |
| Emory University | OTHER |
| Rutgers Cancer Institute of New Jersey | OTHER |
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| 6- and 12-months after enrollment |
| General Health-Related Quality of Life (SF-12) | 6- and 12-months after enrollment |
| San Francisco |
| California |
| 94143 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Lousiana State University Health Sciences Center- New Orleans | New Orleans | Louisiana | 70112 | United States |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |