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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211104
• Other study ID #: 2007-06-068
• Status: Completed
• Phase: N/A
• First received: May 9, 2017
• Last updated: July 5, 2017
• Start date: August 30, 2007
• Est. completion date: August 5, 2015

Study information

• Verified date: May 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: August 5, 2015
• Est. primary completion date: August 5, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• curcumin

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

References & Publications (2)

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. — View 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 4:17-34. doi: 10.1111/bju.13361. Epub 2016 Feb 22. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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