What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as androgen deprivation therapy (ADT) and chemotherapy, often come with significant side effects including fatigue, hot flashes, decreased libido, and increased risk of cardiovascular issues. Chemotherapy can also cause nausea, hair loss, and increased susceptibility to infections. Complementary treatments like curcumin and piperine, which are being studied for their anti-inflammatory properties and ability to enhance bioavailability, generally have milder side effects such as gastrointestinal discomfort. However, their efficacy and safety profiles are less well-established compared to conventional treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including abiraterone acetate (AA) for both docetaxel-pretreated and docetaxel-naïve patients with castration-resistant prostate cancer (CRPC). Abiraterone works by inhibiting androgen production, which is crucial for prostate cancer growth. While curcumin and piperine are being studied for their anti-inflammatory properties and ability to enhance bioavailability, they are not yet FDA-approved for prostate cancer treatment. Other FDA-approved treatments include docetaxel, a chemotherapy agent, and immunotherapies like sipuleucel-T, which are used based on the patient's disease burden and symptoms.

What other types of research exist?

Promising novel alternatives to Curcumin and Piperine for prostate cancer patients include: 1) Hypericin, which has shown photodynamic activity against prostate cancer cells. 2) Selective COX-2 inhibitors, despite their cardiovascular risks, have demonstrated efficacy in reducing adenomatous polyps. 3) Androgen receptor-targeting therapies like Enzalutamide and Abiraterone, which have shown effectiveness in castration-resistant prostate cancer. These alternatives offer different mechanisms of action and potential benefits in managing prostate cancer.

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Curcumin + Piperine for Prostate Cancer

Phase 2

Recruiting

Led By Peter Van Veldhuizen

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For patients with MGUS or low-risk SMM, diagnosis must be according to the definition of the International Myeloma Working Group (IMWG).

At least one of the risk factors below that portends for an increased risk of progression to Multiple Myeloma (MM): Abnormal serum free light chain ratio, M-spike ≥2.0g/dL, ≥ 20% bone marrow clonal plasma cells, Immunoparesis ≥20% reduction from institutional normal standard of uninvolved immunoglobulins.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of enrollment until the date of first documented response assessed up to 12 months

Awards & highlights

Study Summary

This trial will explore the use of curcumin and piperine supplementation to treat early stage prostate cancer and myeloma.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones associated with curcumin and piperine may include digestive discomfort such as nausea, diarrhea, gas, bloating; skin rash; and headache. These are generally considered safe but should be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My MGUS or SMM diagnosis follows international expert guidelines.

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

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I am 18 years old or older.

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I am able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of enrollment until the date of first documented response assessed up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of enrollment until the date of first documented response assessed up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of enrollment until the date of first documented response assessed up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response rate of Curcumin & Piperine supplementation in patients on AS for either early stage prostate cancer or MGUS.

Secondary outcome measures

Progression Free Survival

Trial Design

3Treatment groups

Experimental Treatment

Group I: Smoldering Multiple Myeloma (SMM)Experimental Treatment1 Intervention

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

Group II: Prostate CancerExperimental Treatment1 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 Treatment1 Intervention

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include androgen deprivation therapy (ADT), chemotherapy, and novel antiandrogens. ADT works by reducing androgen levels or blocking their effects, which slows the growth of prostate cancer cells. Chemotherapy targets rapidly dividing cells, including cancer cells, to inhibit their proliferation. Novel antiandrogens, such as enzalutamide, block androgen receptors, preventing cancer cell growth. Anti-inflammatory agents like curcumin may reduce inflammation, which is linked to cancer progression, while piperine enhances the bioavailability of curcumin, making it more effective. These mechanisms are crucial as they target different pathways involved in cancer growth and progression, potentially improving patient outcomes.

Investigating the effects of lycopene and green tea on the metabolome of men at risk of prostate cancer: The ProDiet randomised controlled trial.Mefloquine induces cell death in prostate cancer cells and provides a potential novel treatment strategy in vivo.