Randomized Trial of Adjuvant Curcumin After Prostatectomy

Who is this study for? Adult patients with prostate cancer
What treatments are being studied? Curcumin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Maricruz Ibarra
maricruz.ibarra@utsouthwestern.edu
214-645-8788
Backup
Jessica Williams
jessica.williams2@utsouthwestern.edu
214-648-9195
Time Frame
Start Date: 2014-05
Estimated Completion Date: 2028-12
Participants
Target number of participants: 608
Treatments
Active_comparator: Curcumin
Curcumin 500 mg orally twice a day
Placebo_comparator: sugar pill
placebo orally twice a day
Related Therapeutic Areas
Sponsors
Leads: yair lotan

This content was sourced from clinicaltrials.gov

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