Recruiting NCT02064673
Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Curcumin, placebo.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 30 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Trial of Adjuvant Curcumin After Prostatectomy
Overview
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
Interventions
- Drug Curcumin
Curcumin or placebo 500mg by mouth twice a day for 6 months - Drug placebo
placebo orally twice a day
Primary outcome measures
- Serum prostate specific antigen [Time frame: 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UT Southwestern Medical Center — Dallas
Identifiers
NCT: NCT02064673 · STU 042013-080