Evaluating the addition of metformin and turmeric for prostate cancer treatment
A Feasibility Study Evaluating a Role for Maintenance Therapy in Patients With Biochemically Progressive Castration Sensitive Prostate Cancer on Intermittent Androgen Deprivation Therapy
This study is testing if adding metformin and turmeric to standard prostate cancer treatment helps men feel better and manage their cancer more effectively.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Male |
| Sponsor | University of Arkansas Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Little Rock, Arkansas) |
| Trial ID | NCT06044025 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the feasibility of incorporating a nutritional intervention of metformin and turmeric alongside intermittent Androgen Deprivation Therapy (iADT) for patients with biochemically progressive castration sensitive prostate cancer. Participants will receive both the standard treatment and the nutritional supplements while documenting their intake and completing quality of life questionnaires. Blood and stool samples will be collected to analyze biomarkers and microbiome profiles, contributing to a better understanding of the treatment's impact. The long-term goal is to evaluate the efficacy and safety of this regimen in managing prostate cancer.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with rising PSA levels indicating biochemical progression of castration sensitive prostate cancer.
Not a fit: Patients who have not undergone prior prostatectomy or radiation therapy, or those with significantly elevated PSA levels not eligible for salvage treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes and quality of life for patients with prostate cancer.
How similar studies have performed: While the combination of metformin and turmeric is a novel approach in this context, previous studies have shown potential benefits of these agents in cancer treatment, suggesting a promising avenue for exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Little Rock, Arkansas
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Recruiting)
Study contacts
- Principal investigator: Shi-Ming Tu, MD — University of Arkansas
- Study coordinator: Madison Trujillo
- Email: MTrujillo@uams.edu
- Phone: 5016868274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.