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

Prostate Cancer Clinical Trial

Official title:

Randomized Trial of Adjuvant Curcumin After Prostatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02064673
• Other study ID #: STU 042013-080
• Status: Recruiting
• Phase: Phase 3
• Start date: May 2014
• Est. completion date: June 2026

Study information

• Verified date: September 2023
• Source: University of Texas Southwestern Medical Center
• Contact: Maricruz Ibarra
• Phone: 214-645-8788
• Email: maricruz.ibarra[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival in patients after radical prostatectomy compared to placebo

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 608
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Curcumin
Curcumin or placebo 500mg by mouth twice a day for 6 months
• placebo
placebo orally twice a day

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
yair lotan

Country where clinical trial is conducted

United States, 

Outcome

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