Description:
This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival.
This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival.
Recruiting
Phase 3
Drug | Synonyms | Arms |
---|---|---|
Curcumin | Bio-Curcumin(BCM-95CG), Tumeric | Curcumin |
placebo | sugar pill | Curcumin |
This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival in patients after radical prostatectomy compared to placebo
Name | Type | Description | Interventions |
---|---|---|---|
Curcumin | Active Comparator | Curcumin 500 mg orally twice a day |
|
sugar pill | Placebo Comparator | placebo orally twice a day |
|
Inclusion Criteria: - radical prostatectomy for adenocarcinoma of 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 or plan to take Curcumin during the study
Maximum Eligible Age: | 80 Years |
Minimum Eligible Age: | 30 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Measure: | Serum prostate specific antigen |
Time Frame: | 3 years |
Safety Issue: | |
Description: | Recurrence free survival defined as a total serum prostate specific antigen of <0.2ng/ml. |
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University of Texas Southwestern Medical Center |
January 22, 2021