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The University of Miami Adapt (UAdapt) Trial
NCT06111313 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 667 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06111313 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06111313?
This trial is sponsored by University of Miami, which has 667 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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