Clinical Trials /

Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance

NCT03769766

Description:

This is a prospective study to determine if the use of curcumin randomized against placebo will reduce cancer progression in patients with prostate cancer undergoing active surveillance.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance
  • Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial of Curcumin to Prevent Progression of Biopsy Proven, Low-risk Localized Prostate Cancer Patients Undergoing Active Surveillance

Clinical Trial IDs

  • ORG STUDY ID: STU 012018-071
  • NCT ID: NCT03769766

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
Curcuminbiocurcumax (BCM-95)Curcumin
Placebosugar pillPlacebo

Purpose

This is a prospective study to determine if the use of curcumin randomized against placebo will reduce cancer progression in patients with prostate cancer undergoing active surveillance.

Detailed Description

      Prostate cancer is the most common cancer in men with an estimated 180,890 new cases and
      26,120 deaths from prostate cancer expected in 2016 in the United States. Although the
      lifetime risk of developing prostate cancer, the risk of death is only about 3%. A major
      concern regarding the utility of prostate cancer screening is the risk of over diagnosis and
      subsequent overtreatment. Many patients with small low grade cancers might not benefit from
      treatment and treatment can result in lower quality of life. A major concern for patients and
      physicians using active surveillance (AS) is the risk for progression of disease. Several
      reviews of active surveillance suggest that stage or grade progression occur in approximately
      30% of patients with some patients choosing treatment due to anxiety. Overall survival in AS
      series is uniformly high but the need for close monitoring and anxiety associated with risk
      of progression has inhibited use among patients.

      There are no currently accepted medications to reduce risk of progression in patients with
      active surveillance. With the rising use of AS, there is a role for therapies to reduce risk
      for progression in this population. One promising source of therapies involves use of
      nutraceuticals for the prevention and treatment of human diseases. Curcumin is a widely
      studied nutraceutical that was first discovered about two centuries ago from the rhizomes of
      Curcuma longa (turmeric). Curcumin is a safe supplement and in this study we will evaluate if
      it reduces risk of cancer progression compared to placebo.
    

Trial Arms

NameTypeDescriptionInterventions
CurcuminActive ComparatorOther names for the supplement: BCM-95 CG (Biocurcumax),Tumeric Manufacture- DolCas Biotech, LLC. Classification - type of agent: Supplement Protocol dose: 500 mg twice
  • Curcumin
PlaceboPlacebo ComparatorDrug: placebo placebo orally twice a day Other Names: •sugar pill
  • Placebo

Eligibility Criteria

        Inclusion Criteria:

          -  Age between 45-99 years

          -  Biopsy proven, low-risk, localized prostate cancer (minimum of 8 cores)

          -  May have had biopsy within last 12 months ≤4 cores involved with cancer

          -  Gleason score ≤6 with no Gleason pattern 4

          -  Clinical stage T1c-T2a/b

          -  Serum PSA ≤15 ng/ml

          -  Life expectancy > 5 years

        Exclusion Criteria:

          -  Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonal therapy,
             oral glucocorticoids, GnRH analogues, prostatectomy)

          -  Concurrent or previous use within 6 months of screening of any 5α-reductase inhibitor

          -  Use of anabolic steroids or drugs with antiandrogenic properties

          -  Prostate volume >150 grams

          -  Patients who are taking antiplatelet, anticoagulant agents or have a history of a
             bleeding disorder. Patients taking 81 mg of Aspirin will be allowed to enroll with
             close observation

          -  History of gastric or duodenal ulcers or untreated hyperacidity syndromes. Patients on
             stable doses of GERD medication allowed.

          -  Patients who are currently taking or plan to take Curcumin during the study

          -  Patients with a history of gallbladder surgery or gallstones will be excluded
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:45 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:The primary end point is rate of disease progression.
Time Frame:2 years
Safety Issue:
Description:The primary endpoint is the number of patients who have progressed at 2 years of follow up defined as one of the following events: receipt of primary therapy for prostate cancer (eg, prostatectomy, radiation, hormonal therapy) or pathologic progression (> 4 cores involved, ≥ 50% of any core involved, or any Gleason score ≥ 7)

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Texas Southwestern Medical Center

Trial Keywords

  • prostate cancer
  • active surveillance
  • curcumin

Last Updated

August 21, 2019