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

Randomized Trial of Adjuvant Curcumin After Prostatectomy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02064673

Enrollment

650

Registered

2014-02-17

Start date

2014-05-01

Completion date

2028-12-01

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer, radical prostatectomy

Brief summary

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

Detailed description

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

Interventions

DRUGCurcumin

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

DRUGplacebo

placebo orally twice a day

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

30 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Serum prostate specific antigen	3 years	Recurrence free survival defined as a total serum prostate specific antigen of \<0.2ng/ml.

Countries

United States

Contacts

CONTACTCorey Nixon

Corey.Nixon@UTSouthwestern.edu214-645-8787

CONTACTCatherine Robinson

Catherine.Robinson@UTSouthwestern.edu214-645-8787

PRINCIPAL_INVESTIGATORYair Lotan, MD

University of Texas Southwestern Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026