RecruitingPhase 1NCT06044025

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

Sponsor

University of Arkansas

Enrollment

34 participants

Start Date

Apr 11, 2024

Study Type

INTERVENTIONAL

Conditions

Castration Sensitive Prostate Cancer

Summary

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.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether a maintenance therapy (ongoing low-dose treatment after the main treatment is done) can prevent bladder cancer from coming back in patients who have had a full surgical removal of the bladder. It is a feasibility study, meaning the researchers are first checking whether this approach is practical and acceptable to patients. **You may be eligible if...** - You have had your bladder surgically removed due to bladder cancer - You have completed your main cancer treatment - You are in stable enough health for maintenance therapy **You may NOT be eligible if...** - Your cancer has spread to other organs - You have serious health conditions that prevent ongoing therapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetformin

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.

DRUGTurmeric

Each subject will start with 1,500 mg turmeric po daily with meals. The 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 or resumes at increased dose, the subject may be instructed to stop taking the study treatment and removed from the study.

Locations(1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

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NCT06044025

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