Actively Recruiting
The University of Miami Adapt (UAdapt) Trial
Led by University of Miami · Updated on 2026-02-18
130
Participants Needed
1
Research Sites
473 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
V
Varian Medical Systems
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The University of Miami Adapt (UAdapt) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy confirmed adenocarcinoma of the prostate (including intraductal adenocarcinoma, excluding small cell carcinoma).
- T1-T3 disease based on digital rectal exam and multiparametric MRI.
- Negative metastatic workup for patients with T3 disease, Gleason 8-10, or PSA over 15 ng/mL.
- No evidence of metastasis by clinical or imaging criteria.
- Gleason score between 6 and 10.
- PSA level of 100 ng/mL or less within 3 months before consent.
- Suspicious prostate lesions on multiparametric MRI.
- No previous pelvic radiotherapy.
- No prior radical or total prostatectomy.
- No concurrent active malignancy except nonmetastatic skin cancer or early-stage chronic lymphocytic leukemia unless in remission for 5 years.
- Ability and willingness to sign informed consent.
- Zubrod performance status 2 or lower.
- Age between 35 and 85 years at consent.
- Serum testosterone within 40% of normal limits within 3 months before consent.
- For HypoLEAD patients, post-treatment androgen deprivation therapy must be declared and follow specific timing and duration rules.
- Patients unable to receive iodine or gadolinium contrast due to allergy or poor renal function are eligible.
You will not qualify if you...
- Prior pelvic radiotherapy.
- Prior androgen ablation therapy.
- Prior or planned radical prostate surgery.
- Evidence of nodal or distant metastatic disease.
- Concurrent active malignancy other than allowed exceptions.
- Zubrod status higher than 2.
- Pretreatment PSA over 100 ng/mL or Gleason score below 6.
- Thyroxine (T4) disease.
- Inability to understand or sign informed consent.
- Inability to tolerate diagnostic MRI acquisition (contrast intolerance alone is not exclusionary).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
B
Benjamin Spieler, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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