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Comparison of Duration of Treatment Interruption With or Without Curcumin During the Off Treatment Periods in Patients With Prostate Cancer Undergoing Intermittent Androgen Deprivation Therapy

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
curcumin
Placebo
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring intermittent androgen deprivation therapy, curcumin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • patients diagnosed with prostate cancer in biopsy
  • among patients with biochemical recurrence after treatment(radical prostatectomy, radiation therapy, focal therapy, etc.) for localized prostate cancer or metastatic prostate cancer at the time of diagnosis, who received intermittent androgen deprivation therapy(IAD)
  • patients who off-treatment for the first time by receiving androgen deprivation therapy(ADT) for more than 6 months and PSA nadir remained stable for more than 3 months

Exclusion Criteria:

  • previous history of IAD
  • patient with other serious or ongoing medical or psychiatric disease other than prostate cancer
  • hypersensitivity or suspicious of curcumin
  • history of taking health supplements containing curcumin for prostate cancer treatment before 6 months of clinical trial participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    curcumin

    control

    Arm Description

    Curcumin extracted from curcuma longa linn. formulation : curcumin powder 240mg/capsule general name : Diferuloylmethane Taking curcumin 3 times a day(1,440mg/day) for 6 months at the first off treatment in patients with prostate cancer receiving intermittent androgen deprivation therapy

    The control group Take a placebo containing lactose and vitamin B2. Reddish brown capsules with the same shape as curcumin.

    Outcomes

    Primary Outcome Measures

    Duration of treatment interruption with or without curcumin
    To determine whether the period from the first interruption of the androgen deprivation therapy to the time when androgen deprivation therapy needs to be retreated differ between curcumin group and placebo group

    Secondary Outcome Measures

    Mean change in PSA(ng/ml) from baseline between curcumin group versus placebo
    Measure the mean change of PSA at each point from the baseline and compare differences between the two groups
    Mean change in testosterone(ng/ml) from baseline between curcumin group versus
    Measure the mean change of testosterone at each point from the baseline and compare differences between the two groups
    Adverse events
    Adverse events were recorded according to the Common Terminology Criteria for Adverse Events(CTCAE). Vital sign, blood test and urine analysis were also performed.

    Full Information

    First Posted
    May 9, 2017
    Last Updated
    July 5, 2017
    Sponsor
    Samsung Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03211104
    Brief Title
    Comparison of Duration of Treatment Interruption With or Without Curcumin During the Off Treatment Periods in Patients With Prostate Cancer Undergoing Intermittent Androgen Deprivation Therapy
    Official Title
    Comparison of Duration of Treatment Interruption With or Without Curcumin During the Off Treatment Periods in Patients With Prostate Cancer Undergoing Intermittent Androgen Deprivation Therapy : a Randomized, Double Blind, Placebo-controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 30, 2007 (Actual)
    Primary Completion Date
    August 5, 2015 (Actual)
    Study Completion Date
    August 5, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Samsung Medical Center

    4. Oversight

    5. Study Description

    Brief Summary
    This was a placebo-controlled, double-blind, randomized trial designed with the aim of establishing whether curcumin influenced the duration of treatment interruption and rate of prostatic specific antigen(PSA) progression, compared with placebo among men with prostate cancer receiving intermittent androgen deprivation therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    intermittent androgen deprivation therapy, curcumin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    107 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    curcumin
    Arm Type
    Experimental
    Arm Description
    Curcumin extracted from curcuma longa linn. formulation : curcumin powder 240mg/capsule general name : Diferuloylmethane Taking curcumin 3 times a day(1,440mg/day) for 6 months at the first off treatment in patients with prostate cancer receiving intermittent androgen deprivation therapy
    Arm Title
    control
    Arm Type
    Placebo Comparator
    Arm Description
    The control group Take a placebo containing lactose and vitamin B2. Reddish brown capsules with the same shape as curcumin.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    curcumin
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Duration of treatment interruption with or without curcumin
    Description
    To determine whether the period from the first interruption of the androgen deprivation therapy to the time when androgen deprivation therapy needs to be retreated differ between curcumin group and placebo group
    Time Frame
    up to 42 months
    Secondary Outcome Measure Information:
    Title
    Mean change in PSA(ng/ml) from baseline between curcumin group versus placebo
    Description
    Measure the mean change of PSA at each point from the baseline and compare differences between the two groups
    Time Frame
    0,1,2,3,4,5,6,12,18,30,42 months
    Title
    Mean change in testosterone(ng/ml) from baseline between curcumin group versus
    Description
    Measure the mean change of testosterone at each point from the baseline and compare differences between the two groups
    Time Frame
    0,1,2,3,4,5,6,12,18,30,42 months
    Title
    Adverse events
    Description
    Adverse events were recorded according to the Common Terminology Criteria for Adverse Events(CTCAE). Vital sign, blood test and urine analysis were also performed.
    Time Frame
    0,1,2,3,4,5,6,12,18,30,42 months

    10. Eligibility

    Sex
    Male
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients diagnosed with prostate cancer in biopsy among patients with biochemical recurrence after treatment(radical prostatectomy, radiation therapy, focal therapy, etc.) for localized prostate cancer or metastatic prostate cancer at the time of diagnosis, who received intermittent androgen deprivation therapy(IAD) patients who off-treatment for the first time by receiving androgen deprivation therapy(ADT) for more than 6 months and PSA nadir remained stable for more than 3 months Exclusion Criteria: previous history of IAD patient with other serious or ongoing medical or psychiatric disease other than prostate cancer hypersensitivity or suspicious of curcumin history of taking health supplements containing curcumin for prostate cancer treatment before 6 months of clinical trial participation

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27918718
    Citation
    Cloughesy T, Finocchiaro G, Belda-Iniesta C, Recht L, Brandes AA, Pineda E, Mikkelsen T, Chinot OL, Balana C, Macdonald DR, Westphal M, Hopkins K, Weller M, Bais C, Sandmann T, Bruey JM, Koeppen H, Liu B, Verret W, Phan SC, Shames DS. Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study of Onartuzumab Plus Bevacizumab Versus Placebo Plus Bevacizumab in Patients With Recurrent Glioblastoma: Efficacy, Safety, and Hepatocyte Growth Factor and O6-Methylguanine-DNA Methyltransferase Biomarker Analyses. J Clin Oncol. 2017 Jan 20;35(3):343-351. doi: 10.1200/JCO.2015.64.7685. Epub 2016 Dec 5.
    Results Reference
    background
    PubMed Identifier
    26898239
    Citation
    van Die MD, Bone KM, Emery J, Williams SG, Pirotta MV, Paller CJ. Phytotherapeutic interventions in the management of biochemically recurrent prostate cancer: a systematic review of randomised trials. BJU Int. 2016 Apr;117 Suppl 4(Suppl 4):17-34. doi: 10.1111/bju.13361. Epub 2016 Feb 22.
    Results Reference
    background

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    Comparison of Duration of Treatment Interruption With or Without Curcumin During the Off Treatment Periods in Patients With Prostate Cancer Undergoing Intermittent Androgen Deprivation Therapy

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