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

Trial Summary

What is the purpose of this trial?

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.

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.

What evidence supports the effectiveness of the treatment Curcumin for prostate cancer?

Research shows that curcumin, a natural compound found in turmeric, can inhibit the growth of prostate cancer cells and induce cell death (apoptosis) in both laboratory and animal studies. It has been found to enhance the effects of other treatments, like TRAIL, in making cancer cells more susceptible to treatment. ^{1 2 3 4 5}

Is curcumin safe for human use?

Curcumin, a compound found in turmeric, is generally considered safe for human use and is approved as Generally Regarded as Safe by the US FDA. However, its clinical success is limited due to poor water solubility and rapid metabolism. ^{2 6 7 8 9}

How is curcumin different 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). Unlike traditional hormone therapies or surgeries, curcumin offers a natural alternative with potential chemopreventive properties. ^{1 2 3 8 10}

Research Team

Yair Lotan, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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, 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]

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]

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]

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]

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]

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

2. Greece pubmed.ncbi.nlm.nih.gov

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

3. 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]

4. United States 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. [2013]

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

Curcumin sensitizes TRAIL-resistant xenografts: molecular mechanisms of apoptosis, metastasis and angiogenesis. [2022]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Recent advances in the investigation of curcuminoids. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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

9. Netherlands pubmed.ncbi.nlm.nih.gov

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

10. 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]