Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT03769766
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 291
- Starts
- 2019-03-11
- Expected to finish
- 2030-11-01
- Last updated by the study team
- 2026-06-15
Who can join
Age: 40 and older, up to 89. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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