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

Samsung Medical Center

Status: Completed

Conditions: Prostate Cancer

Treatments: Dietary Supplement: Placebo; Dietary Supplement: curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT03211104

2007-06-068

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: Male

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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107 participants in 2 patient groups, including a placebo group

curcumin

Experimental group

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

Treatment:

Dietary Supplement: curcumin

control

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo