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Metformin and Turmeric for Progressive Prostate Cancer

This study is looking at whether adding metformin (a diabetes medication) and turmeric (a natural supplement) to your current intermittent Androgen Deprivation Therapy (iADT) for prostate cancer is practical. This study is for men aged 18 to 100 who have castration-sensitive prostate cancer (meaning it still responds to hormone therapy) and rising PSA levels after prior prostatectomy (surgery to remove the prostate) or radiation. The main goal is to see if it's feasible to recruit participants and to evaluate how long it takes for your PSA (prostate-specific antigen) levels to rise again while on this nutritional plan with iADT. The study is currently recruiting 34 participants.

Study design
This is an interventional study with a planned enrollment of 34 participants. It is a single-arm study, meaning all participants will receive the same interventions.
What's involved
Participants will take metformin and turmeric daily, complete a pill diary, and have blood and stool samples collected. They will also complete quality of life questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 27 months to evaluate the time to PSA relapse.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06044025

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

Recruiting
PHASE1Ages 18+InterventionalSupportive care
University of Arkansas
~34 participants
Updated 2026-01-15 on ClinicalTrials.gov
What's tested:MetforminTurmeric

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess feasibility of recruitment
Measured over 12 months of enrollment being open
+1 more outcome measured

Conditions

Castration Sensitive Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Arkansas1

Study leadership

  • Shi-Ming Tu, MD · PRINCIPAL_INVESTIGATOR · University of Arkansas

Who to contact

Madison Trujillo
[email protected]
5016868274
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

18 years of age or older.
History of prior prostatectomy and/or radiation therapy to the prostate.
Currently have rising PSA levels ≥ 0.2 ng/ml if they have undergone radical prostatectomy, or a PSA ≥ nadir + 2 if they have received only radiotherapy. Patients who were not offered salvage radiotherapy as an alternative treatment will be considered ineligible (due to a high PSA, other medical concerns).
Currently have at least 2 consecutively rising serum PSA levels more than 1 week apart
Currently have a PSA doubling time \< 9 months obtained within 60 days of consent.
Eugonad with testosterone \> 150 ng/dl at time of consent.
Prior ADT (including iADT) for up to 24 months in association with definitive treatment is permitted if completed at least 12 months prior to consent.
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
Willing to take study agents at the dose specified with meals.
Willing to discontinue current vitamin/mineral supplements and use only those provided by study. Herbal supplements may still be used.

Exclusion

Current Chronic Lymphocytic Leukemia (CLL), Monoclonal Gammopathy of Unknown Significance (MGUS), Renal Cell Carcinoma (RCC) or another cancer requiring active treatment. Indolent or stable malignancies such as non-melanoma skin cancers are allowed.
Any active or deteriorating liver or renal disease, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C or bone marrow deficiency.
Any history of allergic reactions attributed to turmeric, metformin, or other compounds of similar chemical or biologic compositions.
History of lactic acidosis or risk factors for lactic acidosis (e.g., renal impairment, concomitant use of carbonic anhydrase inhibitors such as topiramate, hypoxic states such as acute congestive heart failure, excessive alcohol intake, and hepatic impairment).
Any other condition that, in the opinion of the investigator, might interfere with the safe conduct of the study.

What this trial measures

  • Assess feasibility of recruitment12 months of enrollment being open

    Assessed using frequency (in percentage) of the number of subjects enrolled in the first six and twelve months out of the total desired accrual

  • Evaluate time to PSA relapse with nutritional intervention on iADT.up to 27 months

    Observed from the time of consent to the time of PSA relapse or at the end of the study period (i.e., 27 months), whichever comes first. A survival curve will be used to estimate the accumulated rate of PSA relapse over time (over 27 months).