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.
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.
Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonal therapy, oral glucocorticoids, GnRH analogues, prostatectomy)
Concurrent or previous use within 6 months of screening of any 5α-reductase inhibitor
Use of anabolic steroids or drugs with antiandrogenic properties
Prostate volume >150 cm³
Parallel
Curcumin
DrugTake medication one 500 mg pill of BCM-95 taken twice daily
Placebo
DrugTake medication one 500mg pill twice daily
The primary end point is rate of disease progression.
The primary endpoint is the number of patients who have progressed at 2 years of follow up defined as one of the following events: receipt of primary therapy for prostate cancer (eg, prostatectomy, radiation, hormonal therapy) or pathologic progression (\> 4 cores involved, ≥ 50% of any core involved, or any Gleason score ≥ 7)
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