Curcumin for Prostate Cancer

Overseen By Catherine Robinson

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: 5α-reductase inhibitors, Antiplatelets

Disqualifiers: Prostate treatment, Bleeding disorder, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

291 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether curcumin, a natural supplement in turmeric, can slow prostate cancer progression. Participants will take either curcumin or a placebo (a sugar pill) to determine curcumin's effectiveness. The trial targets men with low-risk prostate cancer that remains confined to the prostate. Ideal candidates have been diagnosed with localized prostate cancer and have not undergone treatments like surgery or chemotherapy. As a Phase 3 trial, this study represents the final step before FDA approval, giving participants the opportunity to contribute to potentially groundbreaking treatment advancements.

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 participate if you are taking certain medications like 5α-reductase inhibitors, anabolic steroids, or drugs with antiandrogenic properties. If you are taking Curcumin, you must be willing to stop.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that curcumin is generally safe for most people. Research indicates that curcumin, derived from turmeric, has been used safely in many clinical trials. For example, one study found it safe when combined with certain chemotherapy drugs. Other studies suggest that daily curcumin supplements might help slow the growth of early-stage prostate cancer.

Most reports indicate that curcumin does not cause serious side effects. However, some individuals might experience mild issues like an upset stomach or diarrhea. Since this trial is in an advanced stage, earlier trials did not find major safety concerns for curcumin in humans. Overall, current evidence supports the safety of curcumin as a supplement, especially in the doses typically tested in clinical trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Curcumin is unique because it's a natural compound derived from turmeric, offering a potentially gentler alternative to conventional prostate cancer treatments like hormone therapy or chemotherapy. Researchers are excited about curcumin because it targets cancer cells through its anti-inflammatory and antioxidant properties, which is different from the way most standard treatments work. This could mean fewer side effects and a more holistic approach to managing prostate cancer.

What evidence suggests that curcumin might be an effective treatment for prostate cancer?

Research has shown that curcumin, a substance in turmeric, might help treat prostate cancer. In this trial, participants will receive either curcumin or a placebo. Studies have found that curcumin can slow tumor growth and reduce PSA levels, which monitor prostate cancer. In animal studies, curcumin successfully slowed cancer spread and caused cancer cells to die. It also blocks certain pathways that cancer cells use to grow and spread. Overall, these findings suggest that curcumin may help slow the progression of prostate cancer in patients under close monitoring. ^{1 3 6 7 8}

Who Is on the Research Team?

Yair Lotan, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Serum PSA ≤15 ng/ml

I am between 40 and 89 years old.

Exclusion Criteria

I have a history of stomach ulcers but have been on stable GERD medication for 2 months.

My prostate is larger than 150 grams.

I have had treatment for prostate cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either curcumin or placebo to evaluate its effect on reducing cancer progression

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Curcumin
• Placebo

Trial Overview

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.

How Is the Trial Designed?

Group I: Curcumin Active Control 1 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: Placebo Placebo Group 1 Intervention

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

Curcumin is already approved in United States, European Union, India, China for the following indications:

Approved in United States as Curcumin for:

• Dietary Supplement

Approved in European Union as Curcuma for:

• Herbal Medicinal Product

Approved in India as Haldi for:

• Traditional Medicine

Approved in China as Jiang Huang for:

• Traditional Chinese Medicine

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

Curcumin, when administered in a synthetic diet at 2% for 6 weeks, significantly inhibited the growth of androgen-dependent prostate cancer cells (LNCaP) in nude mice, demonstrating its potential as an anti-cancer agent.

The study showed that curcumin decreased cell proliferation and increased apoptosis in tumor cells, while also reducing microvessel density, indicating its effectiveness in targeting cancer growth and progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic potential of curcumin in human prostate cancer. III. Curcumin inhibits proliferation, induces apoptosis, and inhibits angiogenesis of LNCaP prostate cancer cells in vivo. Dorai, T., Cao, YC., Dorai, B., et al.[2013]

Curcumin significantly inhibited the growth of TRAIL-resistant LNCaP prostate cancer xenografts in mice by inducing apoptosis and reducing cell proliferation, suggesting its potential as a therapeutic agent.

The study found that curcumin enhances the effectiveness of TRAIL by upregulating apoptosis-related genes and downregulating pro-survival factors, indicating a promising strategy for overcoming TRAIL resistance in prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin sensitizes TRAIL-resistant xenografts: molecular mechanisms of apoptosis, metastasis and angiogenesis. Shankar, S., Ganapathy, S., Chen, Q., et al.[2022]

Curcuma species, particularly C. longa, C. aromatica, and C. xanthorrhiza, are widely used in traditional medicine for treating various health issues, including indigestion and diabetes, due to their active compounds like curcumin.

Research from 1976 to 2008 highlights curcumin's significant anti-inflammatory, antioxidant, and potential anti-cancer properties, revealing its therapeutic mechanisms and genomic effects, which support its use in modern medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in the investigation of curcuminoids. Itokawa, H., Shi, Q., Akiyama, T., et al.[2022]

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]

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]

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]

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]

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]

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