A Randomized, Double-Blind, Placebo-Controlled Trial of Curcumin to Prevent Progression of Biopsy Proven, Low-risk Localized Prostate Cancer Patients Undergoing Active Surveillance
University of Texas Southwestern Medical Center
Summary
This is a prospective study to determine if the use of curcumin randomized against placebo will reduce cancer progression in patients with prostate cancer undergoing active surveillance.
Description
Prostate cancer is the most common cancer in men with an estimated 180,890 new cases and 26,120 deaths from prostate cancer expected in 2016 in the United States. Although the lifetime risk of developing prostate cancer, the risk of death is only about 3%. A major concern regarding the utility of prostate cancer screening is the risk of over diagnosis and subsequent overtreatment. Many patients with small low grade cancers might not benefit from treatment and treatment can result in lower quality of life. A major concern for patients and physicians using active surveillance (AS) is the risk fo…
Eligibility
- Age range
- 40–89 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Age between 40-89 years * Biopsy proven, low-risk, localized prostate cancer (minimum of 8 cores) * May have had biopsy within last 12 months * ≤4 separate locations in the prostate involved with cancer. If multiple cores are obtained from same lesion or area than this will count as one location. * Gleason score ≤6 with no Gleason pattern 4 * Clinical stage T1c-T2a/b * Serum PSA ≤15 ng/ml * Life expectancy \> 5 years Exclusion Criteria: * Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonal therapy, oral glucocorticoids, GnRH analogues, prostate…
Interventions
- DrugCurcumin
Take medication one 500 mg pill of BCM-95 taken twice daily
- DrugPlacebo
Take medication one 500mg pill twice daily
Location
- UT Southwestern Medical CenterDallas, Texas