Prostate Cancer Clinical Trial

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

Summary

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.

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Full Description

Prostate cancer is the most common cancer in men with an estimated 180,890 new cases and 26,120 deaths from prostate cancer expected in 2016 in the United States. Although the lifetime risk of developing prostate cancer, the risk of death is only about 3%. A major concern regarding the utility of prostate cancer screening is the risk of over diagnosis and subsequent overtreatment. Many patients with small low grade cancers might not benefit from treatment and treatment can result in lower quality of life. A major concern for patients and physicians using active surveillance (AS) is the risk for progression of disease. Several reviews of active surveillance suggest that stage or grade progression occur in approximately 30% of patients with some patients choosing treatment due to anxiety. Overall survival in AS series is uniformly high but the need for close monitoring and anxiety associated with risk of progression has inhibited use among patients.

There are no currently accepted medications to reduce risk of progression in patients with active surveillance. With the rising use of AS, there is a role for therapies to reduce risk for progression in this population. One promising source of therapies involves use of nutraceuticals for the prevention and treatment of human diseases. Curcumin is a widely studied nutraceutical that was first discovered about two centuries ago from the rhizomes of Curcuma longa (turmeric). Curcumin is a safe supplement and in this study we will evaluate if it reduces risk of cancer progression compared to placebo.

View Eligibility Criteria

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 cores involved with cancer
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 grams
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 is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

291

Study ID:

NCT03769766

Recruitment Status:

Recruiting

Sponsor:

University of Texas Southwestern Medical Center

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There is 1 Location for this study

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UT Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Yair Lotan, MD
Contact
214-645-8787
[email protected]
Jessica Williams
Contact
214-648-9195
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

291

Study ID:

NCT03769766

Recruitment Status:

Recruiting

Sponsor:


University of Texas Southwestern Medical Center

How clear is this clinincal trial information?

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