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Recruiting Phase 3

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

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About this study

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

Condition
Prostate Cancer
Tested
Curcumin, placebo
Sponsor
yair lotan

Who can join

Age
30 to 80 years
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 15

  • Minimum age: 30 years
  • Maximum age: 80 years
  • Eligible sex: Male
  • Study condition: Prostate Cancer
  • 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 11

  • 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

1 site, 1 recruiting

UT Southwestern Medical Center

Dallas, Texas, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.