Recruiting
Phase 3

Curcumin

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT03769766

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Curcumin

Placebo

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT03769766

Start date

Mar 11, 2019

Status verified date

Jun, 2026

Completion date

Nov, 2030

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 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 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

Study Design

Enrollment

291 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Curcumin

  • Other names for the supplement: BCM-95 CG (Biocurcumax),Tumeric
  • Manufacture- DolCas Biotech, LLC.
  • Classification - type of agent: Supplement
  • Protocol dose: 500 mg twice

placebo comparator: Placebo

Drug: placebo

placebo orally twice a day Other Names: •sugar pill

Interventions

Curcumin

Take medication one 500 mg pill of BCM-95 taken twice daily

Placebo

Take medication one 500mg pill twice daily

Primary outcome measure

  • The primary end point is rate of disease progression. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Catherine Robinson

214-645-8103Catherine.Robinson@utsouthwestern.edu

Maricruz Ibarra

214-645-8788maricruz.ibarra@utsouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Yair Lotan, MD

214-645-8787Yair.Lotan@utsouthwestern.edu

Jessica Williams

214-648-9195Jessica.Williams2@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • prostate cancer
  • active surveillance
  • curcumin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-06-15.