Prostate CancerPhase 2NCT04731844
Curcumin and Piperine in Patients on Surveillance for Monoclonal Gammopathy, Smoldering Myeloma or Prostate Cancer
A Phase 2 study testing Curcumin plus Piperine in people with Prostate Cancer and Multiple Myeloma, run by University of Rochester at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Multiple Myeloma, Smoldering Multiple Myeloma (SMM)
- What is being tested?
- Curcumin plus Piperine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2021to 19 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
The purpose of this study is to determine whether the supplement of curcumin plus peperine can prevent or delay the progression of prostate cancer, monoclonal gammopathy of unknown significant, or low-risk smoldering myeloma into a more aggressive cancer which requires treatment. The investigator will be evaluating a marker in patients blood called MIC-1 to determine whether it could be a useful predictor of whether the disease is improving or progressing.
- Conditions
- Prostate Cancer, Multiple Myeloma, Smoldering Multiple Myeloma (SMM), Monoclonal Gammopathy of Undetermined Significance
- Being tested
- Curcumin plus Piperine
- Keywords
- curcumin, peperine, prostate cancer, Multiple Myeloma, Smoldering Multiple Myeloma (SMM), Monoclonal Gammopathy of Undetermined Significance (MGUS)
- Medical subject headings
- Prostatic Neoplasms, Multiple Myeloma, Smoldering Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin plus PiperineDrug
Also called Curcumin C3 Complex®
Curcumin with piperine is a well-tolerated over-the-counter supplement.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer | Experimental | Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months Receives: Drug: Curcumin plus Piperine |
| Smoldering Multiple Myeloma (SMM) | Experimental | Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months Receives: Drug: Curcumin plus Piperine |
| Monoclonal Gammopathy of Unknown Significance (MGUS) | Experimental | Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months Receives: Drug: Curcumin plus Piperine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate of Curcumin & Piperine Supplementation in Patients on Active Surveillance for Either Early Stage Prostate Cancer or Patients on Observation for MGUS/Low-risk Smoldering Myeloma.
To estimate the proportion of participants achieving a disease-specific response following curcumin and piperine supplementation administered at a dose of 2gm/10mg(2 tablets) orally twice daily for up to 12 months.
For patients with early-stage prostate cancer, response was defined as ≥50% decrease in prostate-specific antigen (PSA) from baseline, confirmed at least 4 weeks apart.
For patients with MGUS or low-risk SMM, response was defined per International Myeloma Working Group (IMWG) criteria as at least a partial response (≥50% reduction in serum M-protein).
The overall response rate equals the number of participants achieving disease-specific response divided by total number analyzed.
Measured: From date of enrollment until the date of first documented response assessed up to 12 months
Secondary outcomes (2)
Percentage of Participants Without Disease Progression or Death at 12 Months
Proportion of participants who remained free from disease progression or death from any cause at 12 months after enrollment. Participants without documented progression or death by 12 months were considered progression-free.
Measured: From enrollment to 12 months
Safety and Tolerability of Curcumin in Combination With Piperine
Adverse events were summarized by grade and event type per CTCAE version 5.0. The safety population included all participants who received at least one dose of curcumin plus piperine. Results are presented as the number (percentage) of participants who experienced at least one adverse event.
Measured: From start of study treatment through study completion, an average of 1 year for non-serious adverse events; and from screening through study completion, an average of 1 year for serious adverse events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start14 Dec 2021
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brea Lipe, University of Rochester
- Investigators
- Brea Lipe, Principal investigator, University of Rochester Wilmot Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731844
- Sponsor's protocol ID
- UMLT20123
- Status last verified
- Apr 2026
- First submitted
- 26 Jan 2021
- Last updated
- 12 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04731844
- Acronym / sponsor ID
- UMLT20123
- Conditions
- Prostate Cancer, Multiple Myeloma, Smoldering Multiple Myeloma (SMM), Monoclonal Gammopathy of Undetermined Significance
- Keywords
- curcumin, peperine, prostate cancer, Multiple Myeloma, Smoldering Multiple Myeloma (SMM), Monoclonal Gammopathy of Undetermined Significance (MGUS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Posted 12 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to determine whether the supplement of curcumin plus peperine can prevent or delay the progression of prostate cancer, monoclonal gammopathy of unknown significant, or low-risk smoldering myeloma into a more aggressive cancer which requires treatment. The investigator will be evaluating a marker in patients blood called MIC-1 to determine whether it could be a useful predictor of whether the disease is improving or progressing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer | Experimental | Drug: Curcumin plus PiperineCurcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months |
| Smoldering Multiple Myeloma (SMM) | Experimental | Drug: Curcumin plus PiperineCurcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months |
| Monoclonal Gammopathy of Unknown Significance (MGUS) | Experimental | Drug: Curcumin plus PiperineCurcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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).
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin plus PiperineAlso: Curcumin C3 Complex®Curcumin with piperine is a well-tolerated over-the-counter supplement. | Drug | Monoclonal Gammopathy of Unknown Significance (MGUS), Prostate Cancer, Smoldering Multiple Myeloma (SMM) |
Primary outcome
Response Rate of Curcumin & Piperine Supplementation in Patients on Active Surveillance for Either Early Stage Prostate Cancer or Patients on Observation for MGUS/Low-risk Smoldering Myeloma.
Time frame: From date of enrollment until the date of first documented response assessed up to 12 months
To estimate the proportion of participants achieving a disease-specific response following curcumin and piperine supplementation administered at a dose of 2gm/10mg(2 tablets) orally twice daily for up to 12 months. For patients with early-stage prostate cancer, response was defined as ≥50% decrease in prostate-specific antigen (PSA) from baseline, confirmed at least 4 weeks apart. For patients with MGUS or low-risk SMM, response was defined per International Myeloma Working Group (IMWG) criteria as at least a partial response (≥50% reduction in serum M-protein). The overall response rate equals the number of participants achieving disease-specific response divided by total number analyzed.
2 secondary outcomes
Percentage of Participants Without Disease Progression or Death at 12 Months
Time frame: From enrollment to 12 months
Safety and Tolerability of Curcumin in Combination With Piperine
Time frame: From start of study treatment through study completion, an average of 1 year for non-serious adverse events; and from screening through study completion, an average of 1 year for serious adverse events.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brea Lipe principal investigator
University of Rochester Wilmot Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Curcumin plus Piperine in people with Prostate Cancer and Multiple Myeloma, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate of Curcumin & Piperine Supplementation in Patients on Active Surveillance for Either Early Stage Prostate Cancer or Patients on Observation for MGUS/Low-risk Smoldering Myeloma. (time frame: From date of enrollment until the date of first documented response assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.