NCT03211104

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable prostate-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2007

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
Last Updated

July 7, 2017

Status Verified

May 1, 2017

Enrollment Period

7.9 years

First QC Date

May 9, 2017

Last Update Submit

July 5, 2017

Conditions

Prostate Cancer

Keywords

intermittent androgen deprivation therapycurcumin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Mean change in PSA(ng/ml) from baseline between curcumin group versus placebo

    0,1,2,3,4,5,6,12,18,30,42 months

  • Mean change in testosterone(ng/ml) from baseline between curcumin group versus

    0,1,2,3,4,5,6,12,18,30,42 months

  • Adverse events

    0,1,2,3,4,5,6,12,18,30,42 months

Study Arms (2)

curcumin

EXPERIMENTAL

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

control

PLACEBO COMPARATOR

The control group Take a placebo containing lactose and vitamin B2. Reddish brown capsules with the same shape as curcumin.

Dietary Supplement: Placebo

Interventions

curcuminDIETARY_SUPPLEMENT
curcumin
PlaceboDIETARY_SUPPLEMENT
control

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 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.

    PMID: 27918718BACKGROUND

  • 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.

    PMID: 26898239BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2017

First Posted

July 7, 2017

Study Start

August 30, 2007

Primary Completion

August 5, 2015

Study Completion

August 5, 2015

Last Updated

July 7, 2017

Record last verified: 2017-05