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Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT02064673
Recruitment Status : Recruiting
First Posted : February 17, 2014
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE February 10, 2014
First Posted Date  ICMJE February 17, 2014
Last Update Posted Date September 9, 2019
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
Serum prostate specific antigen [ Time Frame: 3 years ]
Recurrence free survival defined as a total serum prostate specific antigen of <0.2ng/ml.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02064673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy
Official Title  ICMJE Randomized Trial of Adjuvant Curcumin After Prostatectomy
Brief Summary This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival.
Detailed Description This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival in patients after radical prostatectomy compared to placebo
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Curcumin
    Curcumin or placebo 500mg by mouth twice a day for 6 months
    Other Names:
    • Bio-Curcumin(BCM-95CG)
    • Tumeric
  • Drug: placebo
    placebo orally twice a day
    Other Name: sugar pill
Study Arms  ICMJE
  • Active Comparator: Curcumin
    Curcumin 500 mg orally twice a day
    Interventions:
    • Drug: Curcumin
    • Drug: placebo
  • Placebo Comparator: sugar pill
    placebo orally twice a day
    Interventions:
    • Drug: Curcumin
    • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 14, 2014)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • radical prostatectomy for adenocarcinoma of prostate
  • pathologically confirmed T1-T3 disease
  • no sign of lymph node or metastatic disease
  • Eastern Cooperative Oncology Group(ECOG) status 0-2
  • adequate renal and liver function
  • no plan to receive adjuvant hormone or radiation therapy
  • life expectancy of 3 years

Exclusion Criteria:

  • must not have exceeded 3 months from time of surgery to enrollment into study
  • T3b or T4 or node positive disease
  • hormone therapy before surgery
  • history of gallbladder problems or gallstones, or biliary obstruction
  • radiation therapy as primary treatment after surgery
  • antiplatelet or anticoagulant agents
  • history of gastric or duodenal ulcers or hyperacidity syndromes
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Allison Beaver, RN, BSN 214-645-8787 Allison.Beaver@utsouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02064673
Other Study ID Numbers  ICMJE STU 042013-080
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yair Lotan, MD UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP