Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy
Conditions
Prostate CancerDrugs
Curcumin, placeboSummary
This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival.
Detailed 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
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Maricruz Ibarra
- 214-645-8788
- [email protected]
Principal Investigator
- Yair Lotan, MD
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
Study Plan
Curcumin
ACTIVE_COMPARATOR
Curcumin 500 mg orally twice a day
DRUG:
CurcuminDescription:
Curcumin or placebo 500mg by mouth twice a day for 6 monthsDRUG:
placeboDescription:
placebo orally twice a day
sugar pill
PLACEBO_COMPARATOR
placebo orally twice a day
DRUG:
CurcuminDescription:
Curcumin or placebo 500mg by mouth twice a day for 6 monthsDRUG:
placeboDescription:
placebo orally twice a day
Outcome Measures
Primary Outcome Measures
Serum prostate specific antigen
Timeline
Last Updated
September 19, 2024Start Date
February 17, 2014Today
February 5, 2025Completion Date ( Estimated )
June 1, 2026
Sponsors of this trial
Lead Sponsor
yair lotan