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

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT03769766
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
40 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Curcumin — DRUG
    Take medication one 500 mg pill of BCM-95 taken twice daily
  • Placebo — DRUG
    Take medication one 500mg pill twice daily

Study Details

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.

Key Dates

Start date
Mar 11, 2019
Status verified
Jun 2025
Primary completion
Nov 30, 2029
Completion
Nov 30, 2030

Study Design

Enrollment
291 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390
Yair Lotan, MD
214-645-8787
Jessica Williams
214-648-9195

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