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NCT06044025 · ClinicalTrials.gov registry record · Phase 1
A Feasibility Study Evaluating a Role for Maintenance Therapy in Patients With Biochemically Progressive Castration Sensitive Prostate Cancer on Intermittent Androgen Deprivation Therapy
A Phase 1 study of Castration Sensitive Prostate Cancer, sponsored by University of Arkansas.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT06044025 is a Phase 1 study of Castration Sensitive Prostate Cancer that is actively recruiting participants, run by University of Arkansas. The registered enrollment target is 34 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06044025, a Phase 1 study of Castration Sensitive Prostate Cancer, is actively recruiting participants, sponsored by University of Arkansas.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Metformin
- DRUG Turmeric
Study Locations (1)
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2024-04-11 |
| Est. Completion | 2028-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06044025
The ClinicalTrials.gov registry entry for NCT06044025 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Castration Sensitive Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Metformin is the first listed.
NCT06044025 reports 1 study location spanning 1 distinct geographic area - top geographies include Arkansas.
Frequently Asked Questions
What is clinical trial NCT06044025 about?
NCT06044025 is a clinical study titled "A Feasibility Study Evaluating a Role for Maintenance Therapy in Patients With Biochemically Progressive Castration Sensitive Prostate Cancer on Intermittent Androgen Deprivation Therapy". 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 p...
What is the current status of trial NCT06044025?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2024-04-11. Estimated completion is 2028-10.
What conditions does trial NCT06044025 study?
This clinical trial studies the following conditions: Castration Sensitive Prostate Cancer.
What interventions are being tested in trial NCT06044025?
The interventions under investigation include: Metformin (DRUG), Turmeric (DRUG).
Who is sponsoring clinical trial NCT06044025?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06044025 being conducted?
This trial has 1 study location across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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