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

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

Detailed Description
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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

Official Title
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Randomized Trial of Adjuvant Curcumin After Prostatectomy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Curcumin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Curcumin<br>Curcumin 500 mg orally twice a day | Drug: Curcumin<br>* Curcumin or placebo 500mg by mouth twice a day for 6 months<br>* Other names: Tumeric;Drug: placebo<br>* placebo orally twice a day<br>* Other names: sugar pill;|
| Placebo Comparator: sugar pill<br>placebo orally twice a day | Drug: Curcumin<br>* Curcumin or placebo 500mg by mouth twice a day for 6 months<br>* Other names: Tumeric;Drug: placebo<br>* placebo orally twice a day<br>* Other names: sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, radical prostatectomy