Adjuvant Curcumin to Assess Recurrence Free Survival in P... | NCT02064673

Studies
Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy

NCT02064673

Sponsor

yair lotan

Status

Recruiting

Last Update Posted

Mar 30, 2026Actual

Enrollment

650Estimated

Phase

Phase 3

Conditions

Prostate Cancer

Interventions

Curcumin
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Jun 2028Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Feb 10, 2014

First Submission Date that Met QC Criteria

Feb 14, 2014

First Posted Date

Feb 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2026

Last Update Posted Date

Mar 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

650Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Curcumin	Active Comparator	Curcumin 500 mg orally twice a day	Drug: Curcumin Drug: placebo
sugar pill	Placebo Comparator	placebo orally twice a day	Drug: Curcumin Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Curcumin	Drug	Curcumin or placebo 500mg by mouth twice a day for 6 months	Curcumin sugar pill

Measure	Description	Time Frame
Serum prostate specific antigen	Recurrence free survival defined as a total serum prostate specific antigen of <0.2ng/ml.	3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Status post radical prostatectomy for histologically confirmed adenocarcinoma of the prostate
pathologically confirmed T1-T3 disease
no sign of lymph node or metastatic disease
pT1-pT3pNxMx patients in whom standard NCCN or AUA guidelines would suggest are at low risk for pelvic lymph node or metastatic disease and who would not require confirmatory imaging for metastatic disease. This includes patients with Gleason 6 or 7(T2 disease) and PSA less than 20.
Eastern Cooperative Oncology Group(ECOG) status 0-2
adequate renal and liver function as well as bone marrow reserve (measured serum creatinine <2mg/dl, bilirubin ≤ 1.5 mg/dl, ANC ≥ 1.5 x 10 (3) uL, platelets ≥ 50 x K/uLL, and hemoglobin ≥ 10 g/dL)
30-80 y/o at time of diagnosis with a life expectancy of >= 3 yrs
focally positive surgical margins are permitted
no plan to receive adjuvant hormone or radiation therapy
PSA at the time of enrollment must be undetectable
life expectancy of 3 years

Exclusion Criteria:

must not have exceeded 3 months from time of surgery to enrollment into study
T3b or T4 or node positive disease
macroscopic residual disease after surgery
hormone therapy before surgery
history of gallbladder problems or gallstones, or biliary obstruction, unless patient had cholecystectomy
radiation therapy as primary treatment after surgery
INR value greater than 1.5
AST/ALT are equal or greater than 2 times the upper limit of normal
antiplatelet or anticoagulant agents- patients taking 81mg of Aspirin will be allowed with close observation
history of gastric or duodenal ulcers or untreated hyperacidity syndromes
patients who are currently taking curcumin and are unwilling to stop or plan to take curcumin during the study

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Corey Nixon	Contact	214-645-8787		Corey.Nixon@UTSouthwestern.edu
Catherine Robinson	Contact	214-645-8787		Catherine.Robinson@UTSouthwestern.edu

Overall Officials

Name	Affiliation	Role
Yair Lotan, MD	University of Texas Southwestern Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UT Southwestern Medical Center	Recruiting	Dallas	Texas	75390	United States

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D003474	Curcumin
D000073893	Sugars

ID	Term
D036381	Diarylheptanoids
D006536	Heptanes
D000473	Alkanes
D006839	Hydrocarbons, Acyclic