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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Dietary Supplement: curcumin; Dietary Supplement: Placebo

• Registration Number: NCT03211104
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2007-08-30
• Primary Completion: 2015-08-05
• Study Completion: 2015-08-05
• Status Verified: 2017-05
• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-07-05
• Last Update Submitted: 2017-07-05
• Study First Posted: 2017-07-07
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 107

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Duration of treatment interruption with or without curcumin	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 Outcome Measures

Name	Time	Method
Mean change in PSA(ng/ml) from baseline between curcumin group versus placebo	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
Mean change in testosterone(ng/ml) from baseline between curcumin group versus	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
Adverse events	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.