RecruitingPhase 3NCT03769766

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

A Randomized, Double-Blind, Placebo-Controlled Trial of Curcumin to Prevent Progression of Biopsy Proven, Low-risk Localized Prostate Cancer Patients Undergoing Active Surveillance

Sponsor

University of Texas Southwestern Medical Center

Enrollment

291 participants

Start Date

Mar 11, 2019

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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

Sex: MALEMin Age: 40 YearsMax Age: 89 Years

Inclusion Criteria8

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 Criteria8

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
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 (2 months of therapy) of GERD medication allowed.
Patients who are currently taking Curcumin and are unwilling to stop or plan to take Curcumin during the study
Patients with a history of gallbladder problems or gallstones or biliary obstruction, unless patient had cholecystectomy