Curcumin in Treating Patients with Prostate Cancer That Was Removed by Surgery
- Status post radical prostatectomy for histologically confirmed adenocarcinoma of the prostate
- Pathologically confirmed stage pT1-T3, pN0, M0 disease
- pT1-pT3pNxMx patients in whom standard National Comprehensive Cancer Network (NCCN) or American Urology Association (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 prostate-specific antigen (PSA) less than 20
- All case Eastern Cooperative Oncology Group (ECOG) performance score equal to or less than 2
- Serum creatinine < 2 mg/dl
- Bilirubin =< 1.5 mg/dL
- Absolute neutrophil count (ANC) >= 1.5 x 10 (3)uL
- Platelets >= 50 x K/uL
- Hemoglobin >= 10 g/dL
- Life expectancy of >= 3 years (yrs)
- Focally positive surgical margins are permitted
- No plan to treat with adjuvant hormonal or radiation therapy
- Patients ineligible if the time interval between radical prostatectomy and the first day of randomization exceeds 3 months (+/- 2 weeks)
- Patients with T3b, or T4, or node positive disease will be excluded as they will be considered for adjuvant hormone therapy
- Macroscopic residual disease after surgery
- Patients who received hormone therapy before prostatectomy
- Patients with a history of gallbladder problems or gall stones or biliary obstruction, unless patient had cholecystectomy
- Patients who will receive radiation therapy as their primary treatment after surgery
- International normalized ratio (INR) value greater than 1.5
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) are equal or greater than 2 times the upper limit of normal (ULN)
- Patients who are taking antiplatelet or anticoagulant agents - patients taking 81 mg of aspirin will be allowed with close observation
- History of gastric or duodenal ulcers or untreated hyperacidity syndromes
- Patients who are currently taking or plan to take curcumin during the study
I. Compare recurrence-free survival in patients with prostate cancer after radical prostatectomy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive curcumin orally (PO) twice daily (BID) for 6 months.
ARM II: Patients receive placebo PO BID for 6 months.
After completion of study treatment, patients are followed up every 6 months for 3 years.
Trial Phase Phase II
Trial Type Treatment
UT Southwestern / Simmons Cancer Center-Dallas
- Primary ID 042013-080
- Secondary IDs NCI-2014-01511, CR00008417, Mod6_STU 042013-080
- Clinicaltrials.gov ID NCT02064673