Curcumin + Piperine for Prostate Cancer

Overseen by Brea Lipe, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Rochester

Must not be taking: Curcumin, Piperine

Disqualifiers: Pregnancy, Major surgery, Plasma cell leukemia, others

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if taking curcumin and piperine supplements can help prevent or slow down the progression of early-stage prostate cancer and certain blood conditions. The study will monitor a specific blood test to see if the disease is improving or getting worse. Curcumin, derived from the golden spice turmeric, has poor absorption in the body which can be improved when combined with piperine, a compound found in black pepper.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, you cannot take supplements containing curcumin or piperine during the trial.

What data supports the effectiveness of the treatment Curcumin plus Piperine for prostate cancer?

Research suggests that curcumin, a natural compound found in turmeric, can help slow the growth of prostate cancer cells. Additionally, combining curcumin with other agents has shown potential in treating prostate cancer, indicating that curcumin may be effective as part of a combination treatment. ^{1 2 3 4 5}

Is Curcumin + Piperine safe for humans?

Curcumin, often used in turmeric, has been traditionally used in medicine and is considered nontoxic. Studies show that curcumin and piperine, when used together, have no significant adverse effects in humans and may even help reduce inflammation and other prostate-related issues. ^{5 6 7 8 9}

How does the treatment of Curcumin + Piperine differ from other prostate cancer treatments?

Curcumin, a compound from turmeric, combined with piperine, enhances its absorption and may offer a natural alternative to traditional prostate cancer treatments by potentially reducing cancer cell growth and inflammation. Unlike standard hormone therapy or surgery, this combination focuses on dietary natural products, which might provide a complementary approach with fewer side effects. ^{1 2 5 8 10}

Research Team

Brea Lipe, MD

Principal Investigator

University of Rochester Wilmot Cancer Center

Eligibility Criteria

This trial is for adults over 18 with early-stage prostate cancer opting for active surveillance, or those with Monoclonal Gammopathy of Undetermined Significance (MGUS) or low-risk Smoldering Multiple Myeloma (SMM) not requiring treatment. Participants must have certain risk factors indicating progression to MM and be in good physical condition. Pregnant individuals, recent surgery patients, and those taking curcumin or piperine supplements are excluded.

Inclusion Criteria

My MGUS or SMM diagnosis follows international expert guidelines.

The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.

I have at least one risk factor indicating a high chance of my condition progressing to Multiple Myeloma.

Exclusion Criteria

I have symptoms of a rare blood disorder.

I am currently taking supplements with curcumin or piperine.

I have had major surgery or a significant injury within the last 4 weeks.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Curcumin and Piperine supplementation at a dose of 4 gram/5mg orally twice a day

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Curcumin plus Piperine (Other)

Trial Overview The study tests the effects of a daily dose of curcumin (4 grams) combined with piperine (5 mg), taken twice a day by patients under observation for MGUS/low-risk SMM or early-stage prostate cancer on active surveillance. The goal is to see if these supplements can benefit patients at these stages.

Participant Groups

Group I: Smoldering Multiple Myeloma (SMM) Experimental Treatment 1 Intervention

Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months

Group II: Prostate Cancer Experimental Treatment 1 Intervention

Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months

Group III: Monoclonal Gammopathy of Unknown Significance (MGUS) Experimental Treatment 1 Intervention

Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Kevin Koch

University of Rochester

Chief Executive Officer since 2020

PhD in Organic Chemistry from the University of Rochester

Brian Druker

University of Rochester

Chief Medical Officer since 2015

MD from Harvard Medical School

Findings from Research

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]

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]

In a pilot phase II study involving 30 patients with chemotherapy-naive metastatic castration-resistant prostate cancer, the combination of docetaxel and curcumin showed a promising PSA response rate of 59%, with 40% of evaluable patients achieving a partial response.

The treatment was well tolerated, with no adverse events linked to curcumin, indicating its safety and potential as a complementary therapy in cancer treatment, warranting further randomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The New Combination Docetaxel, Prednisone and Curcumin in Patients with Castration-Resistant Prostate Cancer: A Pilot Phase II Study. Mahammedi, H., Planchat, E., Pouget, M., et al.[2018]

Prostate cancer (PC) is more prevalent and deadly among African American men compared to other ethnic groups, with about 20% diagnosed at a metastatic stage, highlighting a significant health disparity.

The review emphasizes the potential of natural products, specifically curcumin, garlic, and Vernonia amygdalina, as safe and low-cost chemo-preventive agents that could help reduce the incidence and mortality of prostate cancer in African American men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate Cancer Disparity, Chemoprevention, and Treatment by Specific Medicinal Plants. Yedjou, CG., Mbemi, AT., Noubissi, F., et al.[2023]

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]

In a study involving adult gerbils, curcumin and piperine were found to effectively reduce the harmful effects of Bisphenol A (BPA) on the prostate, which included inflammation and abnormal cell growth.

The combination of curcumin and piperine provided the best protective effects against BPA-induced damage, suggesting that these dietary agents can help maintain prostate health by reducing inflammation and promoting normal cell function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective effect of the association of curcumin with piperine on prostatic lesions: New perspectives on BPA-induced carcinogenesis. Facina, CH., Campos, SGP., Ruiz, TFR., et al.[2022]

A systematic review of 11 studies involving 745 patients indicated that turmeric or curcumin supplementation may have beneficial effects on certain prostate disease parameters, such as lowering prostate-specific antigen (PSA) levels and improving quality of life.

No significant adverse effects were reported from curcumin/turmeric supplementation, suggesting it is a safe option; however, the results were mixed, highlighting the need for further research with more bioavailable forms of curcumin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin for the Treatment of Prostate Diseases: A Systematic Review of Controlled Clinical Trials. Bagherniya, M., Askari, G., Alikiaii, B., et al.[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]

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]

References

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

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

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. Switzerland pubmed.ncbi.nlm.nih.gov

The New Combination Docetaxel, Prednisone and Curcumin in Patients with Castration-Resistant Prostate Cancer: A Pilot Phase II Study. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Prostate Cancer Disparity, Chemoprevention, and Treatment by Specific Medicinal Plants. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Therapeutic potential of curcumin in human prostate cancer-I. curcumin induces apoptosis in both androgen-dependent and androgen-independent prostate cancer cells. [2019]

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

Protective effect of the association of curcumin with piperine on prostatic lesions: New perspectives on BPA-induced carcinogenesis. [2022]

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

Curcumin for the Treatment of Prostate Diseases: A Systematic Review of Controlled Clinical Trials. [2021]

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

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

10. 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]