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Phytochemical

Curcumin for Prostate Cancer

Phase 3

Recruiting

Led By Yair Lotan, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy proven, low-risk, localized prostate cancer (minimum of 8 cores)

Age between 40-89 years

Must not have

Prostate volume >150 grams

Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonal therapy, oral glucocorticoids, GnRH analogues, prostatectomy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Pivotal Trial

Summary

This trial will test whether the spice curcumin can help prevent cancer progression in men with prostate cancer.

Who is the study for?

Men aged 40-89 with low-risk, localized prostate cancer (Gleason score ≤6, PSA ≤15 ng/ml) who haven't had previous prostate cancer treatments can join. They should have a life expectancy over 5 years and not be on certain blood thinners or drugs affecting hormones, nor have serious gastric issues or gallbladder problems unless resolved by surgery.

What is being tested?

The study is testing if curcumin (a compound found in turmeric) can prevent the progression of prostate cancer compared to a placebo in patients under active surveillance. Participants will be randomly assigned to either receive curcumin or a placebo.

What are the potential side effects?

Curcumin may cause digestive upset like stomach pain, nausea, diarrhea; it could also increase bleeding risk especially if combined with blood-thinning medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is low-risk and confirmed by biopsy.

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I am between 40 and 89 years old.

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My cancer is in an early stage, but not the earliest.

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My prostate cancer has a low Gleason score without aggressive patterns.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My prostate is larger than 150 grams.

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I have had treatment for prostate cancer before.

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I am currently taking Curcumin and do not plan to stop during the study.

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I had my gallbladder removed or have no history of gallbladder issues.

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I am not using anabolic steroids or drugs that block male hormones.

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I have not used any 5α-reductase inhibitors in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The primary end point is rate of disease progression.

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: CurcuminActive Control1 Intervention

* Other names for the supplement: BCM-95 CG (Biocurcumax),Tumeric * Manufacture- DolCas Biotech, LLC. * Classification - type of agent: Supplement * Protocol dose: 500 mg twice

Group II: PlaceboPlacebo Group1 Intervention

Drug: placebo placebo orally twice a day Other Names: •sugar pill

0 / 10Eligibility criteria met