RECRUITING

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

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Conditions

Castration Sensitive Prostate Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-04-11
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06044025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older.
  2. * History of prior prostatectomy and/or radiation therapy to the prostate.
  3. * 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).
  4. * Currently have at least 2 consecutively rising serum PSA levels more than 1 week apart
  5. * Currently have a PSA doubling time \< 9 months obtained within 60 days of consent.
  6. * Eugonad with testosterone \> 150 ng/dl at time of consent.
  7. * 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.
  8. * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
  9. * Willing to take study agents at the dose specified with meals.
  10. * Willing to discontinue current vitamin/mineral supplements and use only those provided by study. Herbal supplements may still be used.
  1. * 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.
  2. * Any active or deteriorating liver or renal disease, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C or bone marrow deficiency.
  3. * Any history of allergic reactions attributed to turmeric, metformin, or other compounds of similar chemical or biologic compositions.
  4. * 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).
  5. * Any other condition that, in the opinion of the investigator, might interfere with the safe conduct of the study.

Contacts and Locations

Study Contact

Aaron Holley
CONTACT
5016868274
jaholley@uams.edu
Beth Scanlan
CONTACT
5016868274
bscanlan@uams.edu

Principal Investigator

Shi-Ming Tu, MD
PRINCIPAL_INVESTIGATOR
University of Arkansas

Study Locations (Sites)

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States

Collaborators and Investigators

Sponsor: University of Arkansas

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-11
Study Completion Date2026-10

Study Record Updates

Study Start Date2024-04-11
Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

  • Castration Sensitive Prostate Cancer