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

Study Overview
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Brief Summary
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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.

Official Title
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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 : a Randomized, Double Blind, Placebo-controlled Trial

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: curcumin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: curcumin<br>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 | Dietary Supplement: curcumin<br> <br> |
| Placebo Comparator: control<br>The control group Take a placebo containing lactose and vitamin B2. Reddish brown capsules with the same shape as curcumin. | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 42 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 0,1,2,3,4,5,6,12,18,30,42 months | 
| 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 | 0,1,2,3,4,5,6,12,18,30,42 months | 
| 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. | 0,1,2,3,4,5,6,12,18,30,42 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intermittent androgen deprivation therapy, curcumin