NCT02064673RecruitingPhase 3
Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy
Randomized Trial of Adjuvant Curcumin After Prostatectomy
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 650 (estimated)
- First submitted
- 10 Feb 2014
- Start date
- 1 May 2014
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- yair lotan
- Diseases
- Prostate cancer
- NCT number
- NCT02064673
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 650
- From 1 May 2014 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- must not have exceeded 3 months from time of surgery to enrollment into study
- hormone therapy before surgery
- radiation therapy as primary treatment after surgery
- patients who are currently taking curcumin and are unwilling to stop or plan to take curcumin during the study
Other illness
- T3b or T4 or node positive disease
- macroscopic residual disease after surgery
- history of gallbladder problems or gallstones, or biliary obstruction, unless patient had cholecystectomy
- history of gastric or duodenal ulcers or untreated hyperacidity syndromes
Lab values
- INR value greater than 1.5
- AST/ALT are equal or greater than 2 times the upper limit of normal
Other
- antiplatelet or anticoagulant agents- patients taking 81mg of Aspirin will be allowed with close observation
Who the study is looking for
- 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
Age in the registry: 30 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.