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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02064673
Recruitment Status : Recruiting
First Posted : February 17, 2014
Last Update Posted : September 28, 2022
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 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 608 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 2025
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arms and Interventions
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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


Outcome Measures
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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.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Status post radical prostatectomy for histologically confirmed adenocarcinoma of the prostate
  • pathologically confirmed T1-T3 disease
  • no sign of lymph node or metastatic disease
  • pT1-pT3pNxMx patients in whom standard NCCN or AUA guidelines would suggest are at low risk for pelvic lymph node or metastatic disease and who would not require confirmatory imaging for metastatic disease. This includes patients with Gleason 6 or 7(T2 disease) and PSA less than 20.
  • Eastern Cooperative Oncology Group(ECOG) status 0-2
  • adequate renal and liver function as well as bone marrow reserve (measured serum creatinine <2mg/dl, bilirubin ≤ 1.5 mg/dl, ANC ≥ 1.5 x 10 (3) uL, platelets ≥ 50 x K/uLL, and hemoglobin ≥ 10 g/dL)
  • 30-80 y/o at time of diagnosis with a life expectancy of >= 3 yrs
  • focally positive surgical margins are permitted
  • no plan to receive adjuvant hormone or radiation therapy
  • PSA at the time of enrollment must be undetectable
  • 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
  • macroscopic residual disease after surgery
  • hormone therapy before surgery
  • history of gallbladder problems or gallstones, or biliary obstruction, unless patient had cholecystectomy
  • radiation therapy as primary treatment after surgery
  • INR value greater than 1.5
  • AST/ALT are equal or greater than 2 times the upper limit of normal
  • antiplatelet or anticoagulant agents- patients taking 81mg of Aspirin will be allowed with close observation
  • history of gastric or duodenal ulcers or untreated hyperacidity syndromes
  • patients who are currently taking curcumin and are unwilling to stop or plan to take curcumin during the study
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): NCT02064673


Contacts
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Contact: Maricruz Ibarra 214-645-8788 maricruz.ibarra@utsouthwestern.edu
Contact: Jessica Williams 214-648-9195 jessica.williams2@utsouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Maricruz Ibarra    214-645-8788    maricruz.ibarra@utsouthwestern.edu   
Contact: Jessica Williams    214-648-9195    jessica.williams2@utsouthwestern.edu   
Principal Investigator: Yair Lotan, MD         
Sponsors and Collaborators
yair lotan
Investigators
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Principal Investigator: Yair Lotan, MD UT Southwestern Medical Center
More Information
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Responsible Party: yair lotan, PROFESSOR, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02064673    
Other Study ID Numbers: STU 042013-080
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by yair lotan, University of Texas Southwestern Medical Center:
prostate cancer
radical prostatectomy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital 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