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

Launched by YAIR LOTAN · Feb 14, 2014

Keywords

ClinConnect Summary

This clinical trial is studying whether adding Curcumin, a natural compound found in turmeric, can help prevent prostate cancer from coming back after surgery. The trial is specifically looking for men who have had a radical prostatectomy, which is surgery to remove the prostate gland due to cancer, and who are at low risk of the cancer spreading. To be eligible, participants should be between 30 and 80 years old, have no detectable prostate-specific antigen (PSA) levels at the time of enrollment, and not require additional treatments like hormone therapy or radiation.

Participants in this trial can expect to receive Curcumin as part of their follow-up care after surgery. They will be monitored to see if this treatment helps them remain cancer-free longer. It's important to note that participants should not have any serious liver or kidney issues, and they must not have had any hormone therapy or radiation treatment before joining the study. This is an exciting opportunity for men recovering from prostate cancer to potentially improve their long-term health outcomes.

Gender

MALE

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