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

NCT06044025 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 274850
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Castration Sensitive Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Assess feasibility of recruitment

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

  12 months of enrollment being open

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

  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).

  up to 27 months

Secondary Outcomes (2)

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

  up to 27 months

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

  up to 27 months

Other Outcomes (4)

• Expression levels of Metabolomic biomarkers from blood samples

  up to 16 months

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

  up to 16 months

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

  up to 16 months

Study Arms (1)

Metformin + Turmeric

EXPERIMENTAL

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.

Drug: Metformin; Drug: Turmeric

Interventions

Metformin DRUG

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.

Metformin + Turmeric

Turmeric DRUG

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.

Metformin + Turmeric

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

MeSH Terms

Interventions

Metformin; Curcumin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Shi-Ming Tu, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madison Trujillo

CONTACT

5016868274; MTrujillo@uams.edu

Aaron Holley

CONTACT

5016868274; jaholley@uams.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 21, 2023
• Study Start: April 11, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

US (1)