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

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Dec 6, 2018

Keywords

ClinConnect Summary

This clinical trial is studying whether curcumin, a natural substance found in turmeric, can help prevent the progression of low-risk prostate cancer in men who are being monitored closely without immediate treatment, a process known as active surveillance. The trial aims to see if taking curcumin can slow down the growth of the cancer compared to a placebo, which is a harmless substance that looks like the treatment but has no active ingredients.

To join the study, participants must be men aged 40 to 89 years with a confirmed diagnosis of low-risk, localized prostate cancer. This means their cancer has not spread, and it is at a less severe stage. They should have a Gleason score of 6 or lower, which is a way to measure how aggressive the cancer cells are. People who have received treatment for prostate cancer in the past or who are currently on certain medications will not be eligible for this trial. If you decide to participate, you will be randomly assigned to receive either curcumin or a placebo for a certain period, and your health will be monitored regularly to see how the cancer is responding. This trial is currently recruiting participants, so if you or someone you know fits the criteria and is interested, it could be a valuable opportunity to contribute to cancer research.

Gender

MALE

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