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

NCT ID: NCT03769766

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 291 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2030-11-30

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.

Detailed Description

Prostate cancer is the most common cancer in men with an estimated 180,890 new cases and 26,120 deaths from prostate cancer expected in 2016 in the United States. Although the lifetime risk of developing prostate cancer, the risk of death is only about 3%. A major concern regarding the utility of prostate cancer screening is the risk of over diagnosis and subsequent overtreatment. Many patients with small low grade cancers might not benefit from treatment and treatment can result in lower quality of life. A major concern for patients and physicians using active surveillance (AS) is the risk for progression of disease. Several reviews of active surveillance suggest that stage or grade progression occur in approximately 30% of patients with some patients choosing treatment due to anxiety. Overall survival in AS series is uniformly high but the need for close monitoring and anxiety associated with risk of progression has inhibited use among patients.

There are no currently accepted medications to reduce risk of progression in patients with active surveillance. With the rising use of AS, there is a role for therapies to reduce risk for progression in this population. One promising source of therapies involves use of nutraceuticals for the prevention and treatment of human diseases. Curcumin is a widely studied nutraceutical that was first discovered about two centuries ago from the rhizomes of Curcuma longa (turmeric). Curcumin is a safe supplement and in this study we will evaluate if it reduces risk of cancer progression compared to placebo.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Curcumin

Intervention Type: DRUG

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

Placebo

Drug: placebo

placebo orally twice a day Other Names: •sugar pill

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Take medication one 500mg pill twice daily

Interventions

Curcumin

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

Intervention Type: DRUG

Placebo

Take medication one 500mg pill twice daily

Intervention Type: DRUG

Other Intervention Names

biocurcumax (BCM-95); sugar pill

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

yair lotan

MD, Professor and Chief of Urologic Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yair Lotan, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Catherine Robinson

Role: CONTACT

Catherine.Robinson@utsouthwestern.edu

214-645-8103

Maricruz Ibarra

Role: CONTACT

maricruz.ibarra@utsouthwestern.edu

214-645-8788

Facility Contacts

Yair Lotan, MD

Role: primary

Yair.Lotan@utsouthwestern.edu

214-645-8787

Jessica Williams

Role: backup

Jessica.Williams2@utsouthwestern.edu

214-648-9195

Other Identifiers

STU 012018-071

Identifier Type: -

Identifier Source: org_study_id