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

Description

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

Conditions

Prostate Cancer

Study Overview

Study Details

Study overview

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

Randomized Trial of Adjuvant Curcumin After Prostatectomy

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Dallas

UT Southwestern Medical Center, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

30 Years to 80 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

yair lotan,

Yair Lotan, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

2026-06