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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 : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival.

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

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial of Adjuvant Curcumin After Prostatectomy
Study Start Date : May 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Curcumin
Curcumin 500 mg orally twice a day
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
Placebo Comparator: sugar pill
placebo orally twice a day
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



Primary Outcome Measures :
  1. Serum prostate specific antigen [ Time Frame: 3 years ]
    Recurrence free survival defined as a total serum prostate specific antigen of <0.2ng/ml.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02064673


Contacts
Contact: Allison Beaver, RN, BSN 214-645-8787 Allison.Beaver@utsouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Allison Beaver, RN, BSN    214-645-8787    Allison.Beaver@utsouthwestern.edu   
Principal Investigator: Yair Lotan, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Yair Lotan, MD UT Southwestern Medical Center

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02064673     History of Changes
Other Study ID Numbers: STU 042013-080
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Texas Southwestern Medical Center:
prostate cancer
radical prostatectomy

Additional relevant MeSH terms:
Curcumin
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
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