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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Dallas

UT Southwestern Medical Center, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

40 Years to 89 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Texas Southwestern Medical Center,

Yair Lotan, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

2028-11