The University of Miami Adapt (UAdapt) Trial (NCT06111313) | Clinical Trial Compass
RecruitingPhase 2
The University of Miami Adapt (UAdapt) Trial
United States130 participantsStarted 2024-11-06
Plain-language 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.
Who can participate
Age range35 Years – 85 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Biopsy confirmed adenocarcinoma of the prostate (including intraductal adenocarcinoma, excluding small cell carcinoma).
✓. T1-T3 disease based on digital rectal exam (DRE), informed by mpMRI. Prostate MRI may aid in the staging evaluation by verifying organ-confined status6,7. The ability to distinguish between organ-confined tumors (≤T2c) and those that extend beyond the prostate (≥T3a) is an important component of treatment decision making.
✓. Patients with T3 disease based on DRE, mpMRI, Gleason 8-10, or a PSA of \>15 ng/mL, should undergo a negative metastatic workup prior to signing of consent. A questionable bone scan is acceptable if additional imaging studies; eg, plain x-rays, CT, MRI, prostate specific membrane antigen (PSMA) positron emission tomography (PET)/CT do not confirm for metastasis.
✓. No evidence of metastasis by clinical criteria or available radiographic tests (N0M0 by clinical or imaging criteria).
✓. Gleason score 6-10.
✓. Prostate specific antigen (PSA) ≤100 ng/mL within (≤) 3 months of signing of consent. If PSA was above 100 ng/mL and drops to ≤100 ng/mL with antibiotics, this is acceptable for enrollment.
✓. Suspicious peripheral zone or central gland lesion(s) on mpMRI.
✓
What they're measuring
1
Proportion of Patients with Biochemical Disease Failure (FFBN9mo)
Timeframe: Up to 14 Months
2
Proportion of Patients with Clinical Disease Failure
. Peripheral zone: Distinct lesion on dynamic contrast enhanced (DCE)-MRI with early enhancement and later washout (Note: contrast not required for enrollment), and/or distinct lesion on the apparent diffusion coefficient (ADC) map (Value \<1000).
Exclusion criteria
✕. Prior pelvic radiotherapy.
✕. Prior androgen ablation therapy.
✕. Prior or planned radical prostate surgery.
✕. Clinical, radiographic, or pathologic evidence of nodal or distant metastatic disease with the following specifications: PSMA-PET or Fluciclovine PET: Patients with subclinical (\<1.5 cm) pelvic lymph nodes that are suspicious on such PET scans will be ineligible for FTLEAD, however will still be eligible for HypoLEAD. In the latter case the treating physician may boost such nodes to a higher dose.
✕. Concurrent, active malignancy, other than nonmetastatic skin cancer or early-stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for \> 5 years, then the patient is eligible.
✕. Zubrod status \>2.
✕. Pretreatment PSA \>100 ng/ml or Gleason score \<6. If PSA was above 100 ng/mL and drops to ≤100 ng/mL with antibiotics, this is acceptable for enrollment.