Curcumin + Piperine for Prostate Cancer

Overseen By Brea Lipe

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Rochester

Must not be taking: Curcumin, Piperine

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a mix of curcumin and piperine (natural supplements) can benefit individuals with early-stage prostate cancer or those monitored for certain blood conditions, such as MGUS (a condition with abnormal proteins in the blood) or low-risk smoldering myeloma (a slow-growing type of blood cancer). The trial aims to determine if these supplements can make a difference for patients not currently undergoing aggressive treatment. Participants should have early-stage prostate cancer or be under observation for MGUS or low-risk smoldering myeloma and should not be taking similar supplements already. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

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

Past studies have shown that curcumin and piperine are generally safe for people. Curcumin is well-tolerated even in high doses, up to 12 grams a day, over long periods. Researchers have also confirmed the safety of piperine, commonly used in food.

Some individuals might experience mild side effects, such as an upset stomach, when taking these supplements. However, serious side effects are rare. This treatment is in a phase 2 trial, indicating it has been tested before and deemed safe enough for further testing with more participants.

Overall, the combination of curcumin and piperine appears safe based on current research, but individual experiences can vary. Always consult a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about curcumin combined with piperine for prostate cancer because it offers a natural approach with anti-inflammatory and antioxidant properties that differ from standard treatments like hormone therapy, chemotherapy, or radiation. Curcumin, derived from turmeric, can potentially inhibit cancer cell growth, while piperine, found in black pepper, enhances curcumin's absorption and effectiveness. Unlike conventional options, this combination may provide a gentler alternative with fewer side effects, targeting cancer cells while supporting overall health.

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

Research has shown that curcumin, particularly when combined with piperine, may aid in treating prostate cancer by reducing cancer cell viability and decreasing the activity of certain receptors that promote cancer growth. In this trial, participants with prostate cancer will receive curcumin plus piperine to assess its effectiveness.

The trial also includes separate arms for participants with smoldering multiple myeloma and monoclonal gammopathy of unknown significance (MGUS). For smoldering multiple myeloma, curcumin has been effective in increasing remission rates and lowering levels of harmful proteins and inflammation. In the case of MGUS, curcumin has shown potential in reducing disease markers and the amount of abnormal proteins, which indicate the presence and progression of the disease. This combination of curcumin and piperine is under study for its potential to manage these conditions effectively. ^{1 2 3 4 6}

Who Is on the Research Team?

Brea Lipe, MD

Principal Investigator

University of Rochester Wilmot Cancer Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Curcumin plus Piperine

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

Curcumin, a compound found in turmeric, has been identified as a potent inducer of apoptosis (programmed cell death) in both androgen-dependent and hormone-refractory prostate cancer cells, suggesting its potential as a nontoxic treatment option.

The mechanism of action involves curcumin down-regulating proteins that suppress apoptosis and the androgen receptor, which may help prevent the progression of prostate cancer to a more advanced, treatment-resistant stage.

NCBI (Pubmed)

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. Dorai, T., Gehani, N., Katz, A.[2019]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04731844?cond=%22Monoclonal%20Gammopathy%20of%20Uncertain%20Significance%22&intr=%22Enzyme%20Inhibitors%22&viewType=Table&rank=3

Curcumin and Piperine in Patients on Surveillance for ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/268455

Curcumin and Piperine in Patients on Surveillance for ... Response rate of Curcumin & Piperine supplementation in patients on AS for either early stage prostate cancer or MGUS. Measure description. Measure of time from ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3445886/

Curcumin for the prevention of progression in monoclonal ... A recent pilot study found that curcumin, in certain patients with monoclonal gammopathy of undetermined significance (MGUS), decreases the paraprotein load.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10966979/

Regression of Intermediate-High Risk Monoclonal ... We present here an intermediate-high risk MGUS patient who has been taking curcumin for 16 years and has shown a decrease in disease markers and an increase in ...

5. sparkcures.pro sparkcures.pro/trial/1142/NCT04731844

Curcumin and Piperine - Multiple Myeloma Clinical Trials Curcumin is a bright yellow chemical produced by plants of the Curcuma longa species. Ongoing clinical trials are exploring the anticancer effects of curcumin.

6. cancer.gov cancer.gov/research/participate/clinical-trials/intervention/piperine-extract-standardized

Clinical Trials Using Piperine Extract (Standardized) - NCI NCI supports clinical trials that test new and more effective ways to treat cancer. Find clinical trials studying piperine extract (standardized).