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Turmeric + Metformin for Prostate Cancer

Phase 1

Waitlist Available

Led By Shi-Ming Tu, MD

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

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

Must have

History of prior prostatectomy and/or radiation therapy to the prostate

Eugonad with testosterone > 150 ng/dl at time of consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 27 months

Awards & highlights

Study Summary

This trial assesses adding Metformin and turmeric to current care for prostate cancer patients to see if it helps. Participants will take pills, have blood & stool samples taken and complete questionnaires.

Who is the study for?

Men over 18 with prostate cancer who've had surgery or radiation, currently have rising PSA levels, and are on intermittent Androgen Deprivation Therapy (iADT). They must not have other active cancers or severe liver/renal disease, HIV, Hepatitis B/C, bone marrow issues, history of allergic reactions to turmeric/metformin, or risk factors for lactic acidosis.Check my eligibility

What is being tested?

The trial is testing the addition of metformin and turmeric to standard iADT in men with castration sensitive prostate cancer showing biochemical progression. It aims to see if this nutritional intervention affects the time until PSA levels rise again.See study design

What are the potential side effects?

Potential side effects may include digestive issues due to turmeric and metformin such as nausea or diarrhea. Metformin can also cause a rare but serious condition called lactic acidosis especially in people with kidney problems.

Eligibility Criteria

Inclusion Criteria

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

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I have had surgery or radiation for prostate cancer.

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My testosterone levels are above 150 ng/dl.

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I am fully active or can carry out light work.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27 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

Assess feasibility of recruitment

Evaluate time to PSA relapse with nutritional intervention on iADT.

Secondary outcome measures

Quality of Life (QOL) assessed by the Aging Male Symptoms Questionnaire (AMS Questionnaire).

Quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P), Version 4.

Other outcome measures

Expression levels of CSC biomarkers including EMT and miRNAS from blood samples

Expression levels of Cancer dormancy Biomarkers (miR-200s, TGF-beta, BMPs, immune and inflammatory factors) from blood samples

Expression levels of Metabolomic biomarkers from blood samples

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Metformin + TurmericExperimental Treatment2 Interventions

Each subject will begin using metformin and turmeric within 7 days of consent. Subjects will start with metformin 500 mg by mouth (po) two times daily (bid) with meals for 14 days. Metformin titration will then increase to 850 milligram (mg) po bid for 14 days before increasing titration to a desired dosage of 1,000 mg po bid. For those subjects currently taking Metformin, they will continue current dose (if 1,000 mg po bid) or titrate dose as just described until maximum dose is achieved. After two weeks of metformin titration, each subject will start with 1,500 mg turmeric po daily with meals. Dose can be temporarily reduced to 1,000 mg po daily for those who report GI discomfort. If GI discomfort has resolved within one month of the dose reduction, subjects will resume 1,500 mg po daily. If GI discomfort has not resolved the participant may be insturcted to stop taking the study treatment and be removed from the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Turmeric

2011

Completed Phase 3

~480

Metformin

2006

Completed Phase 4

~2430

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor

486 Previous Clinical Trials

150,323 Total Patients Enrolled

2 Trials studying Prostate Cancer

85 Patients Enrolled for Prostate Cancer

Shi-Ming Tu, MDPrincipal InvestigatorUniversity of Arkansas

4 Previous Clinical Trials

370 Total Patients Enrolled

3 Trials studying Prostate Cancer

359 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is a likely candidate to be accepted into this clinical research?

"To be accepted into this medical trial, a patient must have prostate cancer and fall between the ages of 18 to 100 years old. There are 30 available spots in total."

Answered by AI

Are the use of Metformin and Turmeric validated by governmental regulation?

"The safety of Metformin + Turmeric was assessed as a 1, given that this is only the first phase of clinical trials and there are limited reports on its efficacy or risk profile."

Answered by AI

Is this medical experiment open to participants over 45 years old?

"This study's requirements stipulate that qualified participants must have attained the age of consent and be under 100 years old. For those below 18, there are 152 clinical trials available; for adults above 65, 1410 studies can offer potential treatment options."

Answered by AI

Are there still openings to participate in this research project?

"As indicated on clinicaltrials.gov, this medical trial is no longer recruiting participants as of September 12th 2023. However, there are a multitude of alternative trials still in search for volunteers at the present moment - with 1516 studies currently listed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Feasibility Study Evaluating a Role for Maintenance Therapy in Patients With Biochemically Progressive Castration Sensitive Prostate Cancer on Intermittent Androgen Deprivation Therapy

2024. "A Feasibility Study Evaluating a Role for Maintenance Therapy in Patients With Biochemically Progressive Castration Sensitive Prostate Cancer on Intermittent Androgen Deprivation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06044025.