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The purpose of this study is to compare the effects of pomegranate polyphenol pills (POM-X) and a placebo (sugar pill) on prostatic oxidative stress. The placebo is a pill that looks like the POM-X pill but does not have an active ingredient.
Subjects will receive POM-X or placebo pills daily for up to 4 weeks prior to undergoing radical prostatectomy for prostate cancer. Biomarkers in the blood, urine, and prostate tissue will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Pomegranate pill |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomegranate pill | Dietary Supplement | Pomegranate extract pill |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pomegranate oxidative stress | On day of prostate surgery following 4 weeks of taking POM-X or placebo. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allan J Pantuck, MD | University of California, Los Angeles | Principal Investigator |
| Michael Carducci, MD | Johns Hopkins Medical Center | Principal Investigator |
| Stephen J Freedland, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States | ||
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
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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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| Pomegranate pill placebo | Dietary Supplement | Pomegranate pill placebo |
|
|
| Baltimore |
| Maryland |
| 21231 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |