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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: Recruiting Phase 1 study of Castration Sensitive Prostate Cancer, sponsored by University of Arkansas.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessed using frequency (in percentage) of the number of subjects enrolled in the first six and twelve months out of the total desired accrual
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 |
What NCT06044025 shows while recruiting
NCT06044025 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06044025's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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