Prostate Cancer Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Trial of Curcumin to Prevent Progression of Biopsy Proven, Low-risk Localized Prostate Cancer Patients Undergoing Active Surveillance
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.
Status | Recruiting |
Enrollment | 291 |
Est. completion date | November 2028 |
Est. primary completion date | November 2026 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 89 Years |
Eligibility | 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 5a-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 (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 |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary end point is rate of disease progression. | The primary endpoint is the number of patients who have progressed at 2 years of follow up defined as one of the following events: receipt of primary therapy for prostate cancer (eg, prostatectomy, radiation, hormonal therapy) or pathologic progression (> 4 cores involved, = 50% of any core involved, or any Gleason score = 7) | 2 years |
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