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

Phase

Condition

Prostate Cancer

Prostate Disorders

Prostate Cancer, Early, Recurrent

Treatment

Curcumin

Placebo

Clinical Study ID

NCT03769766

STU 012018-071

Ages 40-89
Male

Study 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.

Eligibility Criteria

Inclusion

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 areobtained 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

Exclusion Criteria:

Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonaltherapy, oral glucocorticoids, GnRH analogues, prostatectomy)
Concurrent or previous use within 6 months of screening of any 5α-reductaseinhibitor
Use of anabolic steroids or drugs with antiandrogenic properties
Prostate volume >150 cm³
Patients who are taking antiplatelet, anticoagulant agents or have a history of ableeding disorder. Patients taking 81 mg of Aspirin will be allowed to enroll withclose observation
History of gastric or duodenal ulcers or untreated hyperacidity syndromes. Patientson stable doses (2 months of therapy) of GERD medication allowed.
Patients who are currently taking Curcumin and are unwilling to stop or plan to takeCurcumin during the study
Patients with a history of gallbladder problems or gallstones or biliaryobstruction, unless patient had cholecystectomy

Study Design

Curcumin

March 11, 2019

November 30, 2028

Study 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 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.

Connect with a study center

UT Southwestern Medical Center
Dallas, Texas 75390
United States
Active - Recruiting

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