NCT02064673 · yair lotan
Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy
What this study is about
This is a forward-looking study to determine if the adjuvant use of Curcumin improves recurrence-free survival.
View original scientific description
This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Dallas, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2026 · Source of record for eligibility and locations