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NCT06111313 · ClinicalTrials.gov registry record · Phase 2
The University of Miami Adapt (UAdapt) Trial
A Phase 2 study of Prostate Cancer, sponsored by University of Miami.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
- 1
- Study location
NCT06111313 is a Phase 2 study of Prostate Cancer that is actively recruiting participants, run by University of Miami. The registered enrollment target is 130 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06111313, a Phase 2 study of Prostate Cancer, is actively recruiting participants, sponsored by University of Miami.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this prostate cancer research study is to investigate: 1. For early-stage patients, the use of a single session of high dose stereotactic body radiotherapy (SBRT) delivered to the tumor within the prostate, not to the entire prostate, as curative treatment of prostate cancer; 2. The addition of ultra short-term androgen supression (uSTAS) to a single session of high dose SBRT as a means of intensifying treatment while preserving quality of life and minimizing side effects; 3. The ability of a single session of high dose SBRT to activate your immune system to enhance eradication of prostate cancer; 4. For higher risk patients, the use of a single session of high dose SBRT to the tumor only followed by 25 sessions of radiotherapy targeting the whole prostate as a means to improve control of disease while preserving quality of life and minimizing side effects; 5. The relationship between diagnostic imaging studies and prostate biopsy results in assessing clinical outcomes; and 6. The relationship of pre- and post-treatment prostate biopsy results and imaging studies, such as MRI and PET/CT.
Conditions Studied
Interventions
- RADIATION FTLEAD
- DRUG Ultra-Short-Term Androgen Deprivation Therapy with Relugolix
- RADIATION HypoLEAD
- DRUG ADT Standard of Care
Study Locations (1)
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2024-11-06 |
| Est. Completion | 2033-11-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06111313
The ClinicalTrials.gov registry entry for NCT06111313 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (79% lower). The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which FTLEAD is the first listed.
NCT06111313 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT06111313 about?
NCT06111313 is a clinical study titled "The University of Miami Adapt (UAdapt) Trial". The purpose of this prostate cancer research study is to investigate: 1. For early-stage patients, the use of a single session of high dose stereotactic body radiotherapy (SBRT) delivered to the tumor within the prostate, not to the entire prostate, as curative treatment of prostate cancer; 2. The ...
What is the current status of trial NCT06111313?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2024-11-06. Estimated completion is 2033-11-30.
What conditions does trial NCT06111313 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT06111313?
The interventions under investigation include: FTLEAD (RADIATION), Ultra-Short-Term Androgen Deprivation Therapy with Relugolix (DRUG), HypoLEAD (RADIATION), ADT Standard of Care (DRUG).
Who is sponsoring clinical trial NCT06111313?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06111313 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.