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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: curcumin

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Publications and helpful links

General Publications

• Cloughesy T, Finocchiaro G, Belda-Iniesta C, Recht L, Brandes AA, Pineda E, Mikkelsen T, Chinot OL, Balana C, Macdonald DR, Westphal M, Hopkins K, Weller M, Bais C, Sandmann T, Bruey JM, Koeppen H, Liu B, Verret W, Phan SC, Shames DS. Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study of Onartuzumab Plus Bevacizumab Versus Placebo Plus Bevacizumab in Patients With Recurrent Glioblastoma: Efficacy, Safety, and Hepatocyte Growth Factor and O6-Methylguanine-DNA Methyltransferase Biomarker Analyses. J Clin Oncol. 2017 Jan 20;35(3):343-351. doi: 10.1200/JCO.2015.64.7685. Epub 2016 Dec 5.
• van Die MD, Bone KM, Emery J, Williams SG, Pirotta MV, Paller CJ. Phytotherapeutic interventions in the management of biochemically recurrent prostate cancer: a systematic review of randomised trials. BJU Int. 2016 Apr;117 Suppl 4(Suppl 4):17-34. doi: 10.1111/bju.13361. Epub 2016 Feb 22.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2007
• Primary Completion (Actual): August 5, 2015
• Study Completion (Actual): August 5, 2015

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): July 7, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: curcumin; intermittent androgen deprivation therapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 2007-06-068