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
About This Trial
- This study is testing whether taking curcumin, a natural substance found in turmeric, can help prevent early-stage prostate cancer from growing or getting worse.
- It is designed for men aged 40 to 89 with low-risk cancer who have chosen to closely monitor their condition rather than start immediate surgery or radiation.
- Participants will be randomly chosen to take either curcumin capsules or an inactive dummy pill (placebo) to compare the results.
- Before considering this trial, you should know that you cannot participate if you have previously received prostate cancer treatment, take certain blood-thinning medicines, or have a history of gallbladder problems.
More Information
- 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 Enroll
- Age Range: 40 - 89 years
- Gender: Male
- Who This Trial is For: This study is testing whether taking curcumin, a natural substance found in turmeric, can help prevent early-stage prostate cancer from growing or getting worse.
Study Details
- Start Date: March 11, 2019
- Lead Sponsor: University of Texas Southwestern Medical Center
Full Eligibility 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 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
Treatments
- Drug: Curcumin
- Drug: Placebo