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

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03769766

Provider View

This clinical trial is testing whether curcumin, a natural supplement, can help slow down the progression of low-risk prostate cancer in men who are being closely monitored instead of receiving immediate treatment.

Patient Parameters

Program Overview

The study aims to find out if taking curcumin, a natural supplement derived from turmeric, can help reduce the risk of prostate cancer getting worse in men who are under active surveillance. Active surveillance is a way of monitoring prostate cancer closely without immediate treatment, which can sometimes lead to anxiety about the cancer progressing. Currently, there are no approved medications to prevent cancer progression in these patients, and curcumin is being tested as a potential option.

Description

Prostate cancer is the most common cancer among men, with many cases diagnosed each year. However, not all prostate cancers require immediate treatment, especially if they are low-risk. Active surveillance is a strategy where doctors closely monitor the cancer without treating it right away, to avoid unnecessary side effects from treatments that might not be needed.

One concern with active surveillance is the possibility of the cancer getting worse over time, which happens in about 30% of cases. This can cause anxiety for patients, even though overall survival rates are high. There are currently no accepted medications to prevent this progression, which is why this study is exploring the use of curcumin, a natural supplement from turmeric, to see if it can help. Curcumin is considered safe and has been studied for its potential health benefits. In this trial, researchers will compare the effects of curcumin to a placebo to see if it can reduce the risk of cancer progression.

Eligibility Criteria

Inclusion Criteria

  • Men aged 40 to 89 years old
  • Diagnosed with low-risk, localized prostate cancer confirmed by a biopsy
  • Biopsy within the last 12 months showing cancer in 4 or fewer samples
  • Gleason score of 6 or lower, with no pattern 4
  • Cancer stage T1c to T2a/b
  • PSA level of 15 ng/ml or lower
  • Expected to live more than 5 years

Exclusion Criteria

  • Any previous treatment for prostate cancer, such as radiation, chemotherapy, or surgery
  • Use of certain prostate medications within 6 months before the study
  • Use of anabolic steroids or drugs affecting male hormones
  • Prostate size over 150 grams
  • Taking blood thinners or having a history of bleeding disorders (except for low-dose aspirin with close monitoring)
  • History of stomach ulcers or untreated acid reflux, unless on stable medication
  • Currently taking curcumin and unwilling to stop during the study
  • History of gallbladder issues, unless the gallbladder has been removed

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