Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance

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 for progression of disease. Several
reviews of active surveillance suggest that stage or grade progression occur in approximately
30% of patients with some patients choosing treatment due to anxiety. Overall survival in AS
series is uniformly high but the need for close monitoring and anxiety associated with risk
of progression has inhibited use among patients.

There are no currently accepted medications to reduce risk of progression in patients with
active surveillance. With the rising use of AS, there is a role for therapies to reduce risk
for progression in this population. One promising source of therapies involves use of
nutraceuticals for the prevention and treatment of human diseases. Curcumin is a widely
studied nutraceutical that was first discovered about two centuries ago from the rhizomes of
Curcuma longa (turmeric). Curcumin is a safe supplement and in this study we will evaluate if
it reduces risk of cancer progression compared to placebo.

Inclusion Criteria:

- Age between 45-99 years

- Biopsy proven, low-risk, localized prostate cancer (minimum of 10 cores)

- May have had biopsy within last 12 months ≤4 cores involved with cancer

- Gleason score ≤6 with no Gleason pattern 4

- Clinical stage T1c-T2a/b

- Serum PSA ≤10 ng/ml

- Life expectancy > 5 years

Exclusion Criteria:

- 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 >80 grams

- Patients who are taking antiplatelet, anticoagulant agents or have a history of a
bleeding disorder. Patients taking 81 mg of Aspirin will be allowed to enroll with
close observation

- History of gastric or duodenal ulcers or untreated hyperacidity syndromes. Patients on
stable doses of GERD medication allowed.

- Patients who are currently taking or plan to take Curcumin during the study

- Patients with a history of gallbladder surgery or gallstones will be excluded