RecruitingPhase 3NCT02064673

Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy

Randomized Trial of Adjuvant Curcumin After Prostatectomy

Sponsor

yair lotan

Enrollment

608 participants

Start Date

May 1, 2014

Study Type

INTERVENTIONAL

Conditions

This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival.

Sex: MALEMin Age: 30 YearsMax Age: 80 Years

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)
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

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