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

• ClinicalTrials.gov Identifier: NCT03211104
• Recruitment Status: Completed
• First Posted: July 7, 2017
• Last Update Posted: July 7, 2017
• Sponsor: Samsung Medical Center
• Information provided by (Responsible Party): Samsung Medical Center

Tracking Information

• First Submitted Date: May 9, 2017
• First Posted Date: July 7, 2017
• Last Update Posted Date: July 7, 2017
• Actual Study Start Date: August 30, 2007
• Actual Primary Completion Date: August 5, 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 5, 2017)

Duration of treatment interruption with or without curcumin [ Time Frame: 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 5, 2017)

• Mean change in PSA(ng/ml) from baseline between curcumin group versus placebo [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Official Title: 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

• Dietary Supplement: curcumin
• Dietary Supplement: Placebo

Study Arms

• 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

  Intervention: 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.
  Intervention: Dietary Supplement: Placebo

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 O(6)-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 4:17-34. doi: 10.1111/bju.13361. Epub 2016 Feb 22. Review.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 5, 2017): 107
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 5, 2015
• Actual Primary Completion Date: August 5, 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03211104
• Other Study ID Numbers: 2007-06-068
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Samsung Medical Center
• Study Sponsor: Samsung Medical Center
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Samsung Medical Center
• Verification Date: May 2017