RightFit
RecruitingPhase 3

Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance

A Randomized, Double-Blind, Placebo-Controlled Trial of Curcumin to Prevent Progression of Biopsy Proven, Low-risk Localized Prostate Cancer Patients Undergoing Active Surveillance

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 89 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

This is a prospective study to determine if the use of curcumin randomized against placebo will reduce cancer progression in patients with prostate cancer undergoing active surveillance.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * Age between 40-89 years * Biopsy proven, low-risk, localized prostate cancer (minimum of 8 cores) * May have had biopsy within last 12 months * ≤4 separate locations in the prostate involved with cancer. If multiple cores are obtained from same lesion or area than this will count as one location. * Gleason score ≤6 with no Gleason pattern 4 * Clinical stage T1c-T2a/b * Serum PSA ≤15 ng/ml * Life expectancy \> 5 years Exclusion Criteria: * Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonal therapy, oral glucocorticoids, GnRH analogues, prostatectomy) * Concurrent or previous use within 6 months of screening of any 5α-reductase inhibitor * Use of anabolic steroids or drugs with antiandrogenic properties * Prostate volume \>150 cm³ * Patients who are taking antiplatelet, anticoagulant agents or have a history of a bleeding disorder. Patients taking 81 mg of Aspirin will be allowed to enroll with close observation * History of gastric or duodenal ulcers or untreated hyperacidity syndromes. Patients on stable doses (2 months of therapy) of GERD medication allowed. * Patients who are currently taking Curcumin and are unwilling to stop or plan to take Curcumin during the study * Patients with a history of gallbladder problems or gallstones or biliary obstruction, unless patient had cholecystectomy

Study sites (1)

TX