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

NCT02064673 | Recruiting Phase 3 DMC

• 1 other identifier: STU 042013-080
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival.

Conditions

Prostate Cancer

Keywords

prostate cancer; radical prostatectomy

Outcome Measures

Primary Outcomes (1)

• Serum prostate specific antigen

  Recurrence free survival defined as a total serum prostate specific antigen of \<0.2ng/ml.

  3 years

Study Arms (2)

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

Curcumin DRUG

Curcumin or placebo 500mg by mouth twice a day for 6 months

Also known as: Bio-Curcumin(BCM-95CG), Tumeric

Curcumin; sugar pill

placebo DRUG

placebo orally twice a day

Also known as: sugar pill

Curcumin; sugar pill

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• yair lotan: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Curcumin; Sugars

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Carbohydrates

Study Officials

• Yair Lotan, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corey Nixon

CONTACT

214-645-8787; Corey.Nixon@UTSouthwestern.edu

Catherine Robinson

CONTACT

214-645-8787; Catherine.Robinson@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 17, 2014
• Study Start: May 1, 2014
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)