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

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ClinicalTrials.gov Identifier: NCT03769766
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Yair Lotan, University of Texas Southwestern Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Curcumin Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: placebo/active Curcumin
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial of Curcumin to Prevent Progression of Biopsy Proven, Low-risk Localized Prostate Cancer Patients Undergoing Active Surveillance
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Curcumin

Arms and Interventions
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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 Name: 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 Name: sugar pill


Outcome Measures
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Primary Outcome Measures :
  1. The primary end point is rate of disease progression. [ Time Frame: 2 years ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients have to have prostate cancer
Accepts Healthy Volunteers:   No
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 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 of GERD medication allowed.
  • Patients who are currently taking or plan to take Curcumin during the study
  • Patients with a history of gallbladder surgery or gallstones or biliary obstruction will be excluded, unless patient had cholecystectomy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769766


Contacts
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Contact: Melissa Ramos 214-645-8787 Melissa.Ramos@utsouthwestern.edu
Contact: Donna Mitchell 214-645-8787 donna.mitchell@utsouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Yair Lotan, MD    214-645-8787    Yair.Lotan@utsouthwestern.edu   
Contact: Melissa Ramos    214-645-8787    Melissa.Ramos@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Yair Lotan, MD UT Southwestern Medical Center
More Information
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Responsible Party: Yair Lotan, MD, Professor and Chief of Urologic Oncology, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03769766    
Other Study ID Numbers: STU 012018-071
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yair Lotan, University of Texas Southwestern Medical Center:
prostate cancer
active surveillance
curcumin
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action