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

NCT02064673

Description:

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

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy
  • Official Title: Randomized Trial of Adjuvant Curcumin After Prostatectomy

Clinical Trial IDs

  • ORG STUDY ID: STU 042013-080
  • NCT ID: NCT02064673

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
CurcuminBio-Curcumin(BCM-95CG), TumericCurcumin
placebosugar pillCurcumin

Purpose

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
    

Trial Arms

NameTypeDescriptionInterventions
CurcuminActive ComparatorCurcumin 500 mg orally twice a day
  • Curcumin
  • placebo
sugar pillPlacebo Comparatorplacebo orally twice a day
  • Curcumin
  • placebo

Eligibility Criteria

        Inclusion Criteria:

          -  radical prostatectomy for adenocarcinoma of prostate

          -  pathologically confirmed T1-T3 disease

          -  no sign of lymph node or metastatic disease

          -  Eastern Cooperative Oncology Group(ECOG) status 0-2

          -  adequate renal and liver function

          -  no plan to receive adjuvant hormone or radiation therapy

          -  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

          -  hormone therapy before surgery

          -  history of gallbladder problems or gallstones, or biliary obstruction

          -  radiation therapy as primary treatment after surgery

          -  antiplatelet or anticoagulant agents

          -  history of gastric or duodenal ulcers or hyperacidity syndromes
      
Maximum Eligible Age:80 Years
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Texas Southwestern Medical Center

Trial Keywords

  • prostate cancer
  • radical prostatectomy

Last Updated

May 31, 2016