Recruiting
Phase 3

Curcumin

Sponsor:

yair lotan

Code:

NCT02064673

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Curcumin

placebo

Study Details

Brief summary:

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

Conditions

Prostate Cancer

Study ID

NCT02064673

Start date

May, 2014

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

650 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Curcumin

Curcumin 500 mg orally twice a day

placebo comparator: sugar pill

placebo orally twice a day

Interventions

Curcumin

Curcumin or placebo 500mg by mouth twice a day for 6 months

placebo

placebo orally twice a day

Primary outcome measure

  • Serum prostate specific antigen [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Corey Nixon

214-645-8787Corey.Nixon@UTSouthwestern.edu

Catherine Robinson

214-645-8787Catherine.Robinson@UTSouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Maricruz Ibarra

214-645-8788maricruz.ibarra@utsouthwestern.edu

Jessica Williams

214-648-9195jessica.williams2@utsouthwestern.edu

Principal Investigator:

Yair Lotan, MD

More Information

Sponsor

yair lotan

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • prostate cancer
  • radical prostatectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by yair lotan on 2026-03-30.