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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03211104

Enrollment

107

Registered

2017-07-07

Start date

2007-08-30

Completion date

2015-08-05

Last updated

2017-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

intermittent androgen deprivation therapy, curcumin

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.

Interventions

DIETARY_SUPPLEMENTcurcumin

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026