Actively Recruiting

Phase 3
Age: 30Years - 80Years
MALE
NCT02064673

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

Led by yair lotan · Updated on 2026-03-30

650

Participants Needed

1

Research Sites

761 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 30Years - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Men aged 30 to 80 years at diagnosis with a life expectancy of at least 3 years
  • Status post radical prostatectomy for histologically confirmed adenocarcinoma of the prostate
  • Pathologically confirmed T1 to T3 disease without lymph node or metastatic disease
  • Patients considered low risk for pelvic lymph node or metastatic disease per NCCN or AUA guidelines, including Gleason 6 or 7 (T2 disease) and PSA less than 20
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Adequate kidney and liver function and bone marrow reserve (serum creatinine <2 mg/dL, bilirubin ≤1.5 mg/dL, ANC ≥1.5 x 10^3/uL, platelets ≥50 x 10^3/uL, hemoglobin ≥10 g/dL)
  • Focally positive surgical margins allowed
  • No plan to receive adjuvant hormone or radiation therapy
  • PSA undetectable at enrollment
Not Eligible

You will not qualify if you...

  • More than 3 months have passed from surgery to study enrollment
  • T3b or T4 disease or node positive disease
  • Macroscopic residual disease after surgery
  • Hormone therapy received before surgery
  • History of gallbladder problems, gallstones, or biliary obstruction unless cholecystectomy performed
  • Radiation therapy as primary treatment after surgery
  • INR value greater than 1.5
  • AST or ALT levels at least twice the upper limit of normal
  • Use of antiplatelet or anticoagulant agents, except low-dose aspirin (81mg) with close observation
  • History of gastric or duodenal ulcers or untreated acid-related disorders
  • Currently taking Curcumin and unwilling to stop or planning to take Curcumin during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

C

Corey Nixon

CONTACT

C

Catherine Robinson

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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