Adjuvant Curcumin for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Yair Lotan, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Antiplatelets, Anticoagulants, Curcumin

Disqualifiers: Gallbladder issues, Ulcers, others

Stay on Your Current Meds

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot take curcumin during the study. If you are on antiplatelet or anticoagulant medications, you may need to stop them, except for low-dose aspirin (81mg), which is allowed with close monitoring.

What evidence supports the effectiveness of the drug curcumin for prostate cancer?

Research shows that curcumin, a natural compound found in turmeric, can inhibit the growth of prostate cancer cells and enhance the effects of other cancer treatments. Studies have demonstrated that curcumin can work with other agents to promote cancer cell death and reduce cancer cell proliferation. ^{1 2 3 4 5}

Is curcumin safe for human use?

Curcumin, a compound found in turmeric, is generally considered safe for human use according to the US FDA, but its effectiveness as a treatment is limited by poor solubility and rapid metabolism. ^{1 3 6 7 8}

How does the treatment with curcumin differ from other prostate cancer treatments?

Curcumin, a natural compound found in turmeric, is unique because it can inhibit growth and promote cell death in prostate cancer cells by affecting specific signaling pathways, such as NF-κB and epidermal growth factor receptor (EGF-R) pathways. Unlike traditional hormone therapies or surgeries, curcumin offers a non-invasive, dietary-based approach that may enhance the effects of other treatments like TRAIL and dutasteride. ^{1 2 3 7 9}

Research Team

Yair Lotan, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

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.

Inclusion Criteria

Undetectable PSA at enrollment

Life expectancy of 3 years

I had surgery to remove my prostate due to cancer.

Exclusion Criteria

AST/ALT ≥ 2 times upper limit of normal

It has been over 3 months since my last surgery.

I still have visible cancer after surgery.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Curcumin 500 mg orally twice a day or placebo

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Curcumin (Other)
• placebo (Other)

Trial Overview 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.

Participant Groups

Group I: Curcumin Active Control 2 Interventions

Curcumin 500 mg orally twice a day

Group II: sugar pill Placebo Group 2 Interventions

placebo orally twice a day

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Daniel K. Podolsky

University of Texas Southwestern Medical Center

Chief Executive Officer since 2008

MD from Harvard Medical School

Robert L. Bass

University of Texas Southwestern Medical Center

Chief Medical Officer since 2019

MD from University of Texas Southwestern Medical School

Yair Lotan

Lead Sponsor

Trials

1

Recruited

610+

yair lotan

Lead Sponsor

Trials

1

Recruited

610+

Findings from Research

The combination of curcumin and dutasteride significantly suppressed the proliferation of LNCaP prostate cancer cells and induced apoptosis, suggesting a potential therapeutic strategy for prostate cancer treatment.

This combination treatment also reduced levels of testosterone and dihydrotestosterone in the cancer cells, indicating it may effectively interfere with androgen activity within tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Curcumin Combined With the 5-alpha Reductase Inhibitor Dutasteride on LNCaP Prostate Cancer Cells. Nakayama, A., Ide, H., Lu, Y., et al.[2021]

Curcumin, a compound found in turmeric, significantly enhances the effectiveness of TRAIL in inducing cell death in androgen-sensitive prostate cancer cells (LNCaP), suggesting a potential combination therapy for improved treatment outcomes.

The combination of curcumin and TRAIL activates both the extrinsic and intrinsic pathways of apoptosis, leading to increased cancer cell death, which highlights curcumin's role in sensitizing prostate cancer cells for TRAIL-mediated immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin (diferuloyl-methane) enhances tumor necrosis factor-related apoptosis-inducing ligand-induced apoptosis in LNCaP prostate cancer cells. Deeb, D., Xu, YX., Jiang, H., et al.[2020]

Five out of six curcumin analogues (A(2)-A(6)) were found to be more effective than curcumin itself in inhibiting the growth of PC-3 human prostate cancer cells, suggesting enhanced therapeutic potential.

These analogues also significantly increased apoptosis (cell death) in PC-3 cells and more effectively inhibited NF-κB activity, indicating a possible mechanism for their improved efficacy in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cyclohexanone analogues of curcumin on growth, apoptosis and NF-κB activity in PC-3 human prostate cancer cells. Wei, X., DU, ZY., Cui, XX., et al.[2022]

The review highlights the potential of combining dietary natural products like curcumin, quercetin, soybean isoflavones, silibinin, and EGCG to create synergistic effects that may enhance treatment outcomes for prostate cancer.

These findings suggest that future research could focus on designing hybrid agents that leverage these natural compounds for more effective prostate cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergistic Effects of Dietary Natural Products as Anti-Prostate Cancer Agents. Vue, B., Zhang, S., Chen, QH.[2016]

A significant number of prostate cancer patients (25%-50%) use complementary and alternative medicine (CAM) modalities, primarily vitamins and herbal preparations, despite limited evidence supporting their effectiveness against cancer.

The review concludes that there is insufficient evidence to recommend CAM therapies for prostate cancer treatment outside of clinical trials, highlighting the need for more rigorous evaluation and education for both oncologists and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary and alternative medicines in prostate cancer: from bench to bedside? Klempner, SJ., Bubley, G.[2021]

Curcumin shows promise as a treatment for castration-resistant prostate cancer due to its ability to target multiple pathways, although its low bioavailability limits its effectiveness as a drug.

Research has led to the development of curcumin-based compounds that enhance its anticancer potential and improve pharmacokinetics, making them more suitable for clinical use in prostate cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin-based anti-prostate cancer agents. Chen, QH.[2019]

Prostate cancer is a significant health issue, particularly in the United States and among Black men, with risk factors including age, genetics, and lifestyle choices, highlighting the need for better treatment options.

Curcumin, a compound found in turmeric, shows promise as a therapeutic agent against prostate cancer, with potential mechanisms of action that could inhibit cancer signaling pathways, suggesting it may serve as a chemopreventive agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular mechanisms of curcumin and its semisynthetic analogues in prostate cancer prevention and treatment. Jordan, BC., Mock, CD., Thilagavathi, R., et al.[2018]

Quercetin-decorated liposomes containing curcumin showed improved effectiveness in increasing the lifespan and body weight of mice with Dalton's ascites lymphoma compared to liposomes without quercetin, indicating enhanced therapeutic potential.

The study demonstrated that these liposomes, with a particle size of approximately 261.8 nm, not only improved the cytotoxicity against cancer cells (HT-29 and HCT-15) but also addressed curcumin's limitations like poor solubility and short biological half-life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quercetin-Decorated Curcumin Liposome Design for Cancer Therapy: In-Vitro and In-Vivo Studies. Ravichandiran, V., Masilamani, K., Senthilnathan, B., et al.[2018]

Curcumin, a compound found in turmeric, effectively inhibits the epidermal growth factor receptor (EGF-R) signaling in prostate cancer cells, which could help prevent cancer progression.

The study demonstrated that curcumin reduces EGF-R protein levels, inhibits its tyrosine kinase activity, and blocks its activation by ligands, suggesting it may be a promising preventive therapy for both androgen-dependent and androgen-independent prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic potential of curcumin in human prostate cancer. II. Curcumin inhibits tyrosine kinase activity of epidermal growth factor receptor and depletes the protein. Dorai, T., Gehani, N., Katz, A.[2022]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Effects of Curcumin Combined With the 5-alpha Reductase Inhibitor Dutasteride on LNCaP Prostate Cancer Cells. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Curcumin (diferuloyl-methane) enhances tumor necrosis factor-related apoptosis-inducing ligand-induced apoptosis in LNCaP prostate cancer cells. [2020]

3. Greece pubmed.ncbi.nlm.nih.gov

Effects of cyclohexanone analogues of curcumin on growth, apoptosis and NF-κB activity in PC-3 human prostate cancer cells. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Synergistic Effects of Dietary Natural Products as Anti-Prostate Cancer Agents. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Complementary and alternative medicines in prostate cancer: from bench to bedside? [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Curcumin-based anti-prostate cancer agents. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Molecular mechanisms of curcumin and its semisynthetic analogues in prostate cancer prevention and treatment. [2018]

8. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Quercetin-Decorated Curcumin Liposome Design for Cancer Therapy: In-Vitro and In-Vivo Studies. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Therapeutic potential of curcumin in human prostate cancer. II. Curcumin inhibits tyrosine kinase activity of epidermal growth factor receptor and depletes the protein. [2022]