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

NCT03769766 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: STU 012018-071
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

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

Keywords

prostate cancer; active surveillance; curcumin

Outcome Measures

Primary Outcomes (1)

• The primary end point is rate of disease progression.

  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)

  2 years

Study Arms (2)

Curcumin

ACTIVE COMPARATOR

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

Drug: Curcumin

Placebo

PLACEBO COMPARATOR

Drug: placebo placebo orally twice a day Other Names: •sugar pill

Drug: Placebo

Interventions

Curcumin DRUG

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

Also known as: biocurcumax (BCM-95)

Curcumin

Placebo DRUG

Take medication one 500mg pill twice daily

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 40 Years - 89 Years
• Gender Eligibility Details: Patients have to have prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Curcumin; Sugars

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Carbohydrates

Study Officials

• Yair Lotan, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Robinson

CONTACT

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

Maricruz Ibarra

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor and Chief of Urologic Oncology

Model Details: placebo/active Curcumin

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 10, 2018
• Study Start: March 11, 2019
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2030
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

US (1)