Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance
Recruiting · NCT03769766 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Texas Southwestern Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
CurcuminPlacebo
What this trial is about
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.
Who can take part
Age range
40 Years to 89 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 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 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 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
1 location listed across 1 US state.
- UT Southwestern Medical Center - Dallas, Texas, United States