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Completed

NCT Number: NCT03211104

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Curcumin

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Duration of treatment interruption with or without curcumin

    Time frame: up to 42 months

    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 outcomes

  1. Mean change in PSA(ng/ml) from baseline between curcumin group versus placebo

    Time frame: 0,1,2,3,4,5,6,12,18,30,42 months

    Measure the mean change of PSA at each point from the baseline and compare differences between the two groups

  2. Mean change in testosterone(ng/ml) from baseline between curcumin group versus

    Time frame: 0,1,2,3,4,5,6,12,18,30,42 months

    Measure the mean change of testosterone at each point from the baseline and compare differences between the two groups

  3. Adverse events

    Time frame: 0,1,2,3,4,5,6,12,18,30,42 months

    Adverse events were recorded according to the Common Terminology Criteria for Adverse Events(CTCAE). Vital sign, blood test and urine analysis were also performed.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Jul 7, 2017
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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