Randomized Trial of Adjuvant Curcumin after Radical Prostatectomy

Study ID
STU 042013-080

Cancer Related

Healthy Volunteers

Study Sites

  • UT Southwestern Ambulatory Services

Allison Beaver

Principal Investigator
Yair Lotan


all patients at our institution who undergo radical prostatectomy for prostate cancer will be evaluated for eligibility to enter the study. Patients who are deemed eligible and agree to participate will be randomized to curcumin 500 mg twice a day or placebo. They will be treated for 6 months and then followed for 3 years with PSa measurements every 6 months to assess for recurrence.

Participant Eligibility

1. Status post radical prostatectomy for histologically confirmed adenocarcinoma of the prostate.
2. Pathologically confirmed stage pT1-T3, pN0, M0 disease
3. We will also include 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.
4. All case ECOG performance score equal to or less than 2.
5. Adequate renal and liver function as well as bone marrow reserve (measured serum creatinine<2mg/dl, bilirubin = or < 1.5 mg/dL, ANC >=1.5 x 10(3)uL, platelets >= 50 x K/uL, and hemoglobin >=10 g/dL).
6. 30-80 y/o at time of diagnosis with a life expectancy of >= 3 yrs
7. Focally positive surgical margins are permitted.
8. No plan to treat with adjuvant hormonal or radiation therapy