Using Curcumin to Improve Survival After Prostate Surgery
Randomized Trial of Adjuvant Curcumin After Prostatectomy
This study is testing if adding Curcumin to the treatment plan can help men with low-risk prostate cancer live longer without their cancer coming back after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 650 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | Male |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT02064673 on ClinicalTrials.gov |
What this trial studies
This prospective study aims to evaluate whether the addition of Curcumin as an adjuvant therapy can enhance recurrence-free survival in patients who have undergone radical prostatectomy for prostate cancer. Participants will be randomly assigned to receive either Curcumin or a placebo, and their outcomes will be monitored over time. The study focuses on patients with specific characteristics, including those with low-risk prostate cancer and undetectable PSA levels at enrollment. The goal is to determine if Curcumin can provide a significant benefit in preventing cancer recurrence.
Who should consider this trial
Good fit: Ideal candidates are men aged 30-80 who have had a radical prostatectomy for low-risk prostate cancer and have undetectable PSA levels.
Not a fit: Patients with high-risk features, those requiring adjuvant hormone or radiation therapy, or with detectable PSA levels will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new, non-invasive treatment option to improve survival rates for prostate cancer patients post-surgery.
How similar studies have performed: While the use of Curcumin in cancer treatment is being explored, this specific approach in the context of prostate cancer recurrence is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Status post radical prostatectomy for histologically confirmed adenocarcinoma of the prostate * pathologically confirmed T1-T3 disease * no sign of lymph node or metastatic disease * pT1-pT3pNxMx patients in whom standard NCCN or AUA guidelines would suggest are at low risk for pelvic lymph node or metastatic disease and who would not require confirmatory imaging for metastatic disease. This includes patients with Gleason 6 or 7(T2 disease) and PSA less than 20. * Eastern Cooperative Oncology Group(ECOG) status 0-2 * adequate renal and liver function as well as bone marrow reserve (measured serum creatinine \<2mg/dl, bilirubin ≤ 1.5 mg/dl, ANC ≥ 1.5 x 10 (3) uL, platelets ≥ 50 x K/uLL, and hemoglobin ≥ 10 g/dL) * 30-80 y/o at time of diagnosis with a life expectancy of \>= 3 yrs * focally positive surgical margins are permitted * no plan to receive adjuvant hormone or radiation therapy * PSA at the time of enrollment must be undetectable * life expectancy of 3 years Exclusion Criteria: * must not have exceeded 3 months from time of surgery to enrollment into study * T3b or T4 or node positive disease * macroscopic residual disease after surgery * hormone therapy before surgery * history of gallbladder problems or gallstones, or biliary obstruction, unless patient had cholecystectomy * radiation therapy as primary treatment after surgery * INR value greater than 1.5 * AST/ALT are equal or greater than 2 times the upper limit of normal * antiplatelet or anticoagulant agents- patients taking 81mg of Aspirin will be allowed with close observation * history of gastric or duodenal ulcers or untreated hyperacidity syndromes * patients who are currently taking curcumin and are unwilling to stop or plan to take curcumin during the study
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: Corey Nixon
- Email: Corey.Nixon@UTSouthwestern.edu
- Phone: 214-645-8787
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.