RECRUITING

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

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Prostate Canceractive surveillancecurcumin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2019-03-11
Study Completion:2028-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03769766

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.

Ages Eligible for Study:40 Years to 89 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age between 40-89 years
  2. * Biopsy proven, low-risk, localized prostate cancer (minimum of 8 cores)
  3. * May have had biopsy within last 12 months ≤4 cores involved with cancer
  4. * Gleason score ≤6 with no Gleason pattern 4
  5. * Clinical stage T1c-T2a/b
  6. * Serum PSA ≤15 ng/ml
  7. * Life expectancy \> 5 years
  1. * Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonal therapy, oral glucocorticoids, GnRH analogues, prostatectomy)
  2. * Concurrent or previous use within 6 months of screening of any 5α-reductase inhibitor
  3. * Use of anabolic steroids or drugs with antiandrogenic properties
  4. * Prostate volume \>150 grams
  5. * 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
  6. * History of gastric or duodenal ulcers or untreated hyperacidity syndromes. Patients on stable doses (2 months of therapy) of GERD medication allowed.
  7. * Patients who are currently taking Curcumin and are unwilling to stop or plan to take Curcumin during the study
  8. * Patients with a history of gallbladder problems or gallstones or biliary obstruction,unless patient had cholecystectomy

Contacts and Locations

Study Contact

Jessica Williams
CONTACT
214-648-9195
Jessica.Williams2@utsouthwestern.edu
Maricruz Ibarra
CONTACT
214-645-8788
maricruz.ibarra@utsouthwestern.edu

Principal Investigator

Yair Lotan, MD
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Yair Lotan, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-11
Study Completion Date2028-11

Study Record Updates

Study Start Date2019-03-11
Study Completion Date2028-11

Terms related to this study

Keywords Provided by Researchers

  • prostate cancer
  • active surveillance
  • curcumin

Additional Relevant MeSH Terms

  • Prostate Cancer