Prostate CancerPhase 3NCT03769766
Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance
A Phase 3 study testing Curcumin in people with Prostate Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 89 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 291 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2019to Nov 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Yair Lotan, MD, 214-645-8787, Yair.Lotan@utsouthwestern.edu
Jessica Williams, 214-648-9195, Jessica.Williams2@utsouthwestern.edu
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Curcumin to Prevent Progression of Biopsy Proven, Low-risk Localized Prostate Cancer Patients Undergoing Active Surveillance
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.
Read the detailed 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.
- Conditions
- Prostate Cancer
- Being tested
- Curcumin, Placebo
- Keywords
- prostate cancer, active surveillance, curcumin
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Also called biocurcumax (BCM-95)
Take medication one 500 mg pill of BCM-95 taken twice daily
PlaceboDrug
Also called sugar pill
Take medication one 500mg pill twice daily
| Study group | Role | What they receive |
|---|---|---|
| Curcumin | Active comparator | * Other names for the supplement: BCM-95 CG (Biocurcumax),Tumeric
* Manufacture- DolCas Biotech, LLC.
* Classification - type of agent: Supplement
* Protocol dose: 500 mg twice Receives: Drug: Curcumin |
| Placebo | Placebo comparator | Drug: placebo
placebo orally twice a day Other Names: •sugar pill Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point is rate of disease progression.
The primary endpoint is the number of patients who have progressed at 2 years of follow up defined as one of the following events: receipt of primary therapy for prostate cancer (eg, prostatectomy, radiation, hormonal therapy) or pathologic progression (> 4 cores involved, ≥ 50% of any core involved, or any Gleason score ≥ 7)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start11 Mar 2019
- Primary completionNov 2029 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo/active Curcumin
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 291 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yair lotan, University of Texas Southwestern Medical Center
- Investigators
- Yair Lotan, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769766
- Sponsor's protocol ID
- STU 012018-071
- Status last verified
- Jun 2026
- First submitted
- 5 Dec 2018
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No