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Curcumin to Prevent Progression of Low-risk Prostate Cancer

This study is looking at whether a natural substance called Curcumin can help prevent low-risk prostate cancer from getting worse in men who are being watched closely (active surveillance). You would take either Curcumin (one 500 mg pill twice daily) or a placebo (a pill with no active medicine, one 500mg pill twice daily). The study wants to see if Curcumin can reduce the rate at which the cancer progresses over two years. To join, you need to be a man between 40 and 89 years old with low-risk prostate cancer that has been confirmed by a biopsy. The study is currently unclear on its recruitment status and plans to enroll 291 participants.

Study design
This is an interventional study comparing Curcumin to a placebo. It plans to enroll 291 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at 2 years, suggesting follow-up for at least this long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03769766

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

Recruiting
PHASE3Ages 40–89InterventionalTreatment
University of Texas Southwestern Medical Center
~291 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:CurcuminPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The primary end point is rate of disease progression.
Measured over 2 years

Conditions

Prostate Cancer

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Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Yair Lotan, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Catherine Robinson
[email protected]
214-645-8103
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age between 40-89 years
Biopsy proven, low-risk, localized prostate cancer (minimum of 8 cores)
May have had biopsy within last 12 months
≤4 separate locations in the prostate involved with cancer. If multiple cores are obtained from same lesion or area than this will count as one location.
Gleason score ≤6 with no Gleason pattern 4
Clinical stage T1c-T2a/b
Serum PSA ≤15 ng/ml
Life expectancy \> 5 years

Exclusion

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 cm³
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 (2 months of therapy) of GERD medication allowed.
Patients who are currently taking Curcumin and are unwilling to stop or plan to take Curcumin during the study
Patients with a history of gallbladder problems or gallstones or biliary obstruction, unless patient had cholecystectomy

What this trial measures

  • The primary end point is rate of disease progression.2 years

    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)