Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 89
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
291 (estimated)
Sponsor
University of Texas Southwestern Medical Center · Other
Who this trial is looking for
This trial is looking for men aged 40 to 89 with low-risk prostate cancer who are being monitored without treatment. Participants will take curcumin or a placebo to see if it helps prevent cancer from getting worse.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 40 and 89 years old.
I have low-risk prostate cancer confirmed by a biopsy.
I may have had a biopsy in the last 12 months.
My prostate cancer is found in 4 or fewer locations.
I have a Gleason score of 6 or lower.
My clinical stage is T1c-T2a/b.
My PSA level is 15 ng/ml or lower.
My life expectancy is more than 5 years.
You may not be able to join if
I have had any previous treatment for prostate cancer.
I have used any 5α-reductase inhibitor in the last 6 months.
I use anabolic steroids or antiandrogen drugs.
My prostate volume is larger than 150 cm³.
I take blood thinners or have a bleeding disorder.
I have a history of stomach ulcers or untreated acid issues.
I am taking curcumin and cannot stop during the study.
I have had gallbladder problems or gallstones.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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 co…
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
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