Using curcumin to prevent progression of low-risk prostate cancer
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 study is testing if curcumin, a natural supplement from turmeric, can help slow down low-risk prostate cancer in patients who are being closely monitored.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 291 (estimated) |
| Ages | 40 Years to 89 Years |
| Sex | Male |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT03769766 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether curcumin, a natural supplement derived from turmeric, can reduce the progression of low-risk prostate cancer in patients who are under active surveillance. Participants will be randomly assigned to receive either curcumin or a placebo, allowing researchers to compare the effects of the treatment against a control group. The study aims to address the anxiety and risk of disease progression faced by patients opting for active surveillance, as there are currently no accepted medications to mitigate this risk. By evaluating the efficacy of curcumin, the trial seeks to provide a potential therapeutic option for managing low-risk prostate cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 40-89 with biopsy-proven, low-risk localized prostate cancer who are under active surveillance.
Not a fit: Patients who have previously undergone treatment for prostate cancer or have high prostate volume may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a safe and effective way to reduce cancer progression in men with low-risk prostate cancer, potentially improving their quality of life.
How similar studies have performed: While the use of curcumin in cancer treatment is promising, this specific approach to prevent progression in low-risk prostate cancer under active surveillance is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Yair Lotan, MD — University of Texas Southwestern Medical Center
- Study coordinator: Catherine Robinson
- Email: Catherine.Robinson@utsouthwestern.edu
- Phone: 214-645-8103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.