Clinical trial NCT03211104: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: intermittent androgen deprivation therapy
curcumin
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 107
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Duration of treatment interruption with or without curcumin
timeFrame: up to 42 months
Secondary outcomes:
measure: Mean change in PSA(ng/ml) from baseline between curcumin group versus placebo
timeFrame: 0,1,2,3,4,5,6,12,18,30,42 months
measure: Mean change in testosterone(ng/ml) from baseline between curcumin group versus
timeFrame: 0,1,2,3,4,5,6,12,18,30,42 months
measure: Adverse events
timeFrame: 0,1,2,3,4,5,6,12,18,30,42 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.