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

NCT02064673 · University of Texas Southwestern Medical Center
In plain English

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Official title
Randomized Trial of Adjuvant Curcumin After Prostatectomy
About this study
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
Eligibility criteria
Inclusion Criteria: * 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 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 curcumin and are unwilling to stop or plan to take curcumin during the study
Study design
Enrollment target: 650 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2014-05
Estimated completion: 2028-12
Last updated: 2026-03-30
Interventions
Drug: CurcuminDrug: placebo
Primary outcomes
  • Serum prostate specific antigen (3 years)
Sponsor
yair lotan · other
Contacts & investigators
ContactCorey Nixon · contact · Corey.Nixon@UTSouthwestern.edu · 214-645-8787
ContactCatherine Robinson · contact · Catherine.Robinson@UTSouthwestern.edu · 214-645-8787
InvestigatorYair Lotan, MD · principal_investigator, University of Texas Southwestern Medical Center
All locations (1)
UT Southwestern Medical CenterRecruiting
Dallas, Texas, United States
Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy · TrialPath