What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly those with anti-inflammatory and antioxidant properties like curcumin, include hormonal agents, NSAIDs, and complementary therapies. Hormonal agents can cause side effects such as hot flashes, decreased libido, and fatigue. NSAIDs, while potentially reducing cancer risk, can lead to gastrointestinal issues, cardiovascular problems, and kidney damage with long-term use. Complementary therapies, such as acupuncture, may help manage symptoms but can vary in effectiveness and may have mild side effects like soreness or bruising at needle sites. Overall, side effects are generally mild but can vary depending on the specific treatment and patient condition.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including abiraterone acetate (AA) and enzalutamide, which are used for castration-resistant prostate cancer (CRPC). Abiraterone was initially approved for patients pretreated with docetaxel and later for those who are docetaxel-naïve. Enzalutamide has shown benefits in both pre- and post-docetaxel settings. While curcumin is being studied for its potential benefits due to its anti-inflammatory and antioxidant properties, it is not yet FDA-approved for prostate cancer treatment. Other treatments like docetaxel, a chemotherapy agent, and radium-223, a radiopharmaceutical, have also been approved for advanced stages of the disease.

What other types of research exist?

Promising novel alternatives to Curcumin for prostate cancer treatment include: 1) Immune checkpoint inhibitors like Pembrolizumab and Dostarlimab for patients with specific genetic markers (dMMR or high TMB). 2) Combination therapies targeting DNA repair mechanisms, such as Olaparib combined with Abiraterone. 3) Lutetium-177-PSMA-617, a radioligand therapy for metastatic castration-resistant prostate cancer. These alternatives have shown potential in clinical trials and may offer new avenues for treatment in 2024.

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Adjuvant 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

Focally positive surgical margins permitted

Aged 30-80 at time of diagnosis with a life expectancy of >= 3 yrs

Must not have

Macroscopic residual disease after surgery

Hormone therapy before surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing if Curcumin, a natural compound from turmeric, can help prevent cancer from returning in patients who have had their prostate removed. The study focuses on its potential to reduce inflammation and protect cells. The goal is to see if it helps patients stay cancer-free. Curcumin, derived from turmeric, has been extensively studied for its anti-inflammatory and anticancer properties, particularly in prostate cancer.

Who is the study for?

Men aged 30-80 with prostate cancer who've had surgery to remove the prostate, no lymph node or metastatic disease, and a life expectancy of at least 3 years. They should not have severe liver, kidney, or bone marrow problems and must not be planning additional hormone or radiation therapy post-surgery.

What is being tested?

The study is testing if Curcumin can prevent cancer from coming back in patients who've undergone surgery for prostate cancer. Participants will either receive Curcumin or a placebo to see which one helps more in stopping the cancer's return.

What are the potential side effects?

Curcumin may cause digestive issues like upset stomach or diarrhea and has been associated with gallbladder problems. It might also interact with blood thinners causing bleeding risks.

Eligibility Criteria

Inclusion Criteria

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

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My surgery showed cancer cells at the edge of the removed tissue.

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I was diagnosed between ages 30-80 and expected to live 3 more years or longer.

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I had surgery to remove my prostate due to cancer.

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My cancer is in an early stage and hasn't spread to lymph nodes or other parts.

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My prostate cancer is at an early stage, not spread widely, with low PSA levels.

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I am able to care for myself and perform daily activities.

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My kidney, liver, and bone marrow are functioning well according to recent tests.

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I am not planning to undergo hormone or radiation therapy after surgery.

Exclusion Criteria

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

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I still have visible cancer after surgery.

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I have received hormone therapy before surgery.

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I had my gallbladder removed due to previous issues.

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I received radiation therapy as my main treatment after surgery.

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I am currently using or plan to use curcumin during the study.

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I have had stomach or duodenal ulcers, or untreated acid reflux.

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My cancer is advanced or has spread to my lymph nodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Serum prostate specific antigen

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 Control2 Interventions

Curcumin 500 mg orally twice a day

Group II: sugar pillPlacebo Group2 Interventions

placebo orally twice a day

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include androgen deprivation therapy (ADT), which reduces androgen levels to slow cancer growth; chemotherapy, which uses drugs to kill rapidly dividing cancer cells; and immunotherapy, which boosts the body's immune system to target cancer cells. Curcumin, an alternative treatment being studied, has anti-inflammatory and antioxidant properties that may help reduce cancer cell proliferation and improve recurrence-free survival. These mechanisms are crucial for prostate cancer patients as they offer different approaches to manage and potentially reduce the progression of the disease.