Curcumin and Piperine in Patients on Surveillance for Monoclonal Gammopathy, Smoldering Myeloma or Prostate Cancer

Q: What is the NCT04731844 clinical trial studying?

To explore the use of curcumin and piperine supplementation at a dose of 4 gram/5mg twice a day in early stage prostate cancer patient undergoing active surveillance or patients on observation for MGUS/ low-risk smoldering myeloma. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Q: Who can participate in NCT04731844?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT04731844?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

Efficacy of Curcumin and Piperine in Patients on Active Surveillance for Either Monoclonal Gammopathy of Unknown Significance (MGUS), Low-risk Smoldering Multiple Myeloma (SMM) or Early Stage Prostate Cancer: A Pilot Study

Curcumin and Piperine in Patients on Surveillance for Monoclonal Gammopathy, Smoldering Myeloma or Prostate Cancer (NCT04731844) is a Phase 2 interventional studying Prostate Cancer and Multiple Myeloma, sponsored by University of Rochester. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Prostate Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - The patient or a legally authorized representative must provide study-specific willing to sign a consent form prior to study entry. - Age ≥ 18 years of age. - Karnofsky performance status (KPS) of ≥ 70%. - Subjects with either 1) non-metastatic biopsy proven adenocarcinoma of the prostate who have chosen AS the treatment option for their prostate cancer or 2) have the diagnosis of either MGUS or low-risk SMM and are currently on observation alone. - For patients with MGUS or low-risk SMM, diagnosis must be according to the definition of the International Myeloma Working Group (IMWG). 1. MGUS: serum M-protein \<3.0g/dL, \<10% clonal plasma cells (PCs) in the bone marrow, and absence of end-organ damage (CRAB criteria) that can be attributed to the plasma cell disorder. 2. SMM: serum M-protein of ≥3.0g/dL or a proportion of clonal PCs in the BM of ≥10% but \<60%, and no evidence of end organ damage as described below. - Absence of end organ damage is defined by absence of CRAB criteria: - C: Absence of hypercalcemia, defined as calcium ≤11mg/dL. - R: Absence of renal failure, defined as serum creatinine ≤2.0mg/dL. - A: Absence of anemia, defined as blood count (hemoglobin) at least 10g/dL. - B: Absence of lytic bone lesions per IMWG recommendations: One of either PET-CT, low-dose whole-body CT, or whole- body MRI. Increased uptake on PET-CT alone is not adequate for the diagnosis of multiple myeloma; evidence of underlying osteolytic bone destruction is needed on the CT portion of the examination. - At least one of the risk factors below that portends for an increased risk of progression to 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. Exclusion Criteria - Currently taking supplements containing either curcumin or piperine. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry. * Age ≥ 18 years of age. * Karnofsky performance status (KPS) of ≥ 70%. * Subjects with either 1) non-metastatic biopsy proven adenocarcinoma of the prostate who have chosen AS the treatment option for their prostate cancer or 2) have the diagnosis of either MGUS or low-risk SMM and are currently on observation alone. * For patients with MGUS or low-risk SMM, diagnosis must be according to the definition of the International Myeloma Working Group (IMWG). 1. MGUS: serum M-protein \<3.0g/dL, \<10% clonal plasma cells (PCs) in the bone marrow, and absence of end-organ damage (CRAB criteria) that can be attributed to the plasma cell disorder. 2. SMM: serum M-protein of ≥3.0g/dL or a proportion of clonal PCs in the BM of ≥10% but \<60%, and no evidence of end organ damage as described below. * Absence of end organ damage is defined by absence of CRAB criteria: * C: Absence of hypercalcemia, defined as calcium ≤11mg/dL. * R: Absence of renal failure, defined as serum creatinine ≤2.0mg/dL. * A: Absence of anemia, defined as hemoglobin ≥10g/dL. * B: Absence of lytic bone lesions per IMWG recommendations: One of either PET-CT, low-dose whole-body CT, or whole- body MRI. Increased uptake on PET-CT alone is not adequate for the diagnosis of multiple myeloma; evidence of underlying osteolytic bone destruction is needed on the CT portion of the examination. * At least one of the risk factors below that portends for an increased risk of progression to 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. Exclusion Criteria * Currently taking supplements containing either curcumin or piperine. * Plan to start any additional over the counter supplements prior to or during trial period. * For prostate cancer patients must not be planning to undergoing primary curative therapy for their prostate cancer (radiation, surgery, brachytherapy). * For MGUS/ SMM patients, must not have had evidence of disease progression which might require treatment during the one-year study period. * Other: symptomatic plasma cell leukemia, amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein). * Subject is pregnant or breast feeding, or planning to become pregnant during the treatment period. * Evidence of any of the following conditions per subject self-report or medical chart review: Major surgery or significant traumatic injury occurring within 4 weeks before enrollment.

Treatments Being Tested

DRUG

Curcumin plus Piperine

Curcumin with piperine is a well-tolerated over-the-counter supplement.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Rochester

Rochester, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04731844), the sponsor (University of Rochester), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04731844 clinical trial studying?

To explore the use of curcumin and piperine supplementation at a dose of 4 gram/5mg twice a day in early stage prostate cancer patient undergoing active surveillance or patients on observation for MGUS/ low-risk smoldering myeloma. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04731844?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04731844?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04731844. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04731844. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.