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

• Status: Recruiting
• Trial end date: 2026-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Curcumin

Criteria

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 cores involved with cancer

• 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, 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 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 Curcumin and are unwilling to stop or plan to take Curcumin during the study

• Patients with a history of gallbladder surgery or gallstones or biliary obstruction,unless patient had cholecystectomy