Actively Recruiting
A Feasibility Study Evaluating a Role for Maintenance Therapy in Patients With Biochemically Progressive Castration Sensitive Prostate Cancer on Intermittent Androgen Deprivation Therapy
Led by University of Arkansas · Updated on 2026-01-15
34
Participants Needed
1
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to assess the feasibility of adding a combination of metformin and turmeric as part of a nutritional intervention regimen to the current standard of care, namely, intermittent Androgen Deprivation Therapy (iADT), for patients with castration sensitive biochemical progressive prostate cancer. The main objectives are: * Assess the feasibility of the study population and enrollment. * Evaluate time to PSA relapse with nutritional intervention on iADT. Participants who are receiving iADT will be dispensed Metformin and turmeric and complete a pill diary. Participants will also have blood and stool samples collected and complete quality of life questionnaires. The long-term goal is to further assess the efficacy and safety of this nutritional regimen and the roles of metabolic syndrome, microenvironment/microbiome, and genomic vs epigenomic profiles in the care of these patients through a clinical trial.
CONDITIONS
Official Title
A Feasibility Study Evaluating a Role for Maintenance Therapy in Patients With Biochemically Progressive Castration Sensitive Prostate Cancer on Intermittent Androgen Deprivation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- History of prior prostatectomy and/or radiation therapy to the prostate
- Currently have rising PSA levels 60.2 ng/ml if post-radical prostatectomy, or PSA 60 nadir + 2 if only radiotherapy
- At least 2 consecutively rising serum PSA levels more than 1 week apart
- PSA doubling time less than 9 months within 60 days of consent
- Eugonadal with testosterone greater than 150 ng/dl at consent
- Prior ADT (including iADT) for up to 24 months if completed at least 12 months before consent
- ECOG performance status of 0 or 1
- Willing to take study agents at specified doses with meals
- Willing to stop current vitamin/mineral supplements and use only those provided by study (herbal supplements allowed)
You will not qualify if you...
- Current Chronic Lymphocytic Leukemia, Monoclonal Gammopathy of Unknown Significance, Renal Cell Carcinoma, or other cancer needing active treatment
- Active or worsening liver or kidney disease, HIV, Hepatitis B or C, or bone marrow deficiency
- History of allergic reactions to turmeric, metformin, or related compounds
- History or risk factors for lactic acidosis such as renal impairment, certain medications, acute heart failure, excessive alcohol use, or liver impairment
- Any condition that may interfere with safe conduct of the study according to investigator judgment
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
Research Team
M
Madison Trujillo
CONTACT
A
Aaron Holley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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