Study on Using Curcumin to Improve Cancer-Free Survival After Prostate Surgery

Sponsor: yair lotan

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02064673

Provider View

This clinical trial is exploring whether taking curcumin, a natural supplement, can help prevent the return of prostate cancer in patients who have had surgery to remove the prostate.

Patient Parameters

Program Overview

The purpose of this study is to find out if taking curcumin, a natural supplement, can help prevent prostate cancer from coming back in patients who have had their prostate removed. The study will compare the effects of curcumin to a placebo (a pill with no active ingredient) to see if it improves the chances of staying cancer-free.

Description

This study is designed to see if curcumin, a natural supplement, can help prevent prostate cancer from returning in patients who have had surgery to remove their prostate. Participants will be randomly assigned to receive either curcumin or a placebo, and their health will be monitored to see if curcumin helps them stay cancer-free longer than those who do not take it.

Eligibility Criteria

Inclusion Criteria

  • Have had surgery to remove the prostate due to prostate cancer.
  • Cancer was confirmed to be in stages T1 to T3.
  • No signs of cancer spreading to lymph nodes or other parts of the body.
  • Considered low risk for cancer spreading based on medical guidelines.
  • Have a Gleason score of 6 or 7 and a PSA level less than 20.
  • Be in good general health with an ECOG status of 0 to 2.
  • Have normal kidney, liver, and bone marrow function based on specific blood tests.
  • Be between 30 and 80 years old at diagnosis, with a life expectancy of at least 3 years.
  • May have small areas of cancer left at the edges of the removed tissue.
  • No plans to receive additional hormone or radiation therapy.
  • PSA level must be undetectable at the time of joining the study.

Exclusion Criteria

  • More than 3 months have passed since surgery.
  • Cancer was in stage T3b, T4, or had spread to lymph nodes.
  • Visible cancer remains after surgery.
  • Received hormone therapy before surgery.
  • Have a history of gallbladder issues unless the gallbladder was removed.
  • Received radiation therapy as the main treatment after surgery.
  • Have a blood clotting test (INR) greater than 1.5.
  • Liver enzymes (AST/ALT) are twice the normal limit or higher.
  • Taking blood thinners, except for low-dose aspirin with close monitoring.
  • Have a history of stomach or intestinal ulcers or untreated acid problems.
  • Currently taking curcumin and unwilling to stop, or plan to take it during the study.

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