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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
This study has been completed.
Sponsor:
Samsung Medical Center
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT03211104
First received: May 9, 2017
Last updated: July 5, 2017
Last verified: May 2017
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Purpose
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.
| Condition | Intervention |
|---|---|
| Prostate Cancer | Dietary Supplement: curcumin Dietary Supplement: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
prostate cancer
MedlinePlus related topics:
Prostate Cancer
U.S. FDA Resources
Further study details as provided by Samsung Medical Center:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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.
| Enrollment: | 107 |
| Actual Study Start Date: | August 30, 2007 |
| Study Completion Date: | August 5, 2015 |
| Primary Completion Date: | August 5, 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: curcumin
Curcumin extracted from curcuma longa linn.
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 |
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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More Information
Publications:
| Responsible Party: | Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT03211104 History of Changes |
| Other Study ID Numbers: |
2007-06-068 |
| Study First Received: | May 9, 2017 |
| Last Updated: | July 5, 2017 |
Keywords provided by Samsung Medical Center:
|
intermittent androgen deprivation therapy curcumin |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Androgens Curcumin Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 11, 2017