Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06044025 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints: details revised at 2 of 2 entries
    • Eligibility criteria expanded, about 2 words
  2. Primary completion date: Oct 2026 to Oct 2027
    • Enrollment target: 30 to 34
    • Study completion date: Oct 2027 to Oct 2028
    • Site contact updated
    v10
  3. Primary completion date: Oct 2025 to Oct 2026
    • Study completion date: Oct 2026 to Oct 2027
    v9
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2024 to Apr 11, 2024
    • Site details revised
    v8
  5. Start date: Feb 2024 to Apr 2024v7
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Dec 2023 to Feb 2024v6
  2. Re-verified, no change to tracked fieldsv5
  3. Start date: Oct 2023 to Dec 2023v4
  4. Primary completion date: Sep 2025 to Oct 2025
    • Study completion date: Sep 2026 to Oct 2026
    • Start date: Sep 2023 to Oct 2023
    v3
  5. Secondary endpoints revised (2)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06044025
Lead Sponsor University of Arkansas
Conditions
(from sponsor)		 Castration Sensitive Prostate Cancer
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov