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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

          -  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 or plan to take Curcumin during the study
      
Maximum Eligible Age:80 Years
Minimum Eligible Age:30 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 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Texas Southwestern Medical Center

Trial Keywords

  • prostate cancer
  • radical prostatectomy

Last Updated

January 22, 2021