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

A Randomized, Double-Blind, Placebo-Controlled Trial of Curcumin to Prevent Progression of Biopsy Proven, Low-risk Localized Prostate Cancer Patients Undergoing Active Surveillance

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Curcumin; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 291
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jessica Williams; Phone Number: 214-648-9195; Email: Jessica.Williams2@utsouthwestern.edu
• Study Contact Backup: Name: Maricruz Ibarra; Phone Number: 214-645-8788; Email: maricruz.ibarra@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center
      • Contact: Jessica Williams; Phone Number: 214-648-9195; Email: Jessica.Williams2@utsouthwestern.edu
      • Contact: Yair Lotan, MD; Phone Number: 214-645-8787; Email: Yair.Lotan@utsouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 87 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 cores involved with cancer
• 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 grams
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Curcumin; Take medication one 500 mg pill of BCM-95 taken twice daily; Other Names: biocurcumax (BCM-95)
Placebo Comparator: Placebo; Drug: placebo placebo orally twice a day Other Names: •sugar pill	Drug: Placebo; Take medication one 500mg pill twice daily; Other Names: sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Yair Lotan, MD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: prostate cancer; active surveillance; curcumin
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: STU 012018-071

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No