NCT06111313

The University of Miami Adapt (UAdapt) Trial

A Phase 2 Risk Adapted Parallel Randomized Trial of MRI-Guided Lattice Stereotactic Focal Radiotherapy of the Prostate With or Without Ultra-Short Term Androgen Deprivation Therapy-The Miami UAdapt Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: Male
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

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

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	FTLEAD	In focal therapy lattice extreme ablative (FTLEAD) RT, the multiparametric-MRI (mpMRI) defined gross tumor volume (GTV) will receive 16-20 Gy in a single fraction of RT to the targeted area which is the tumor within the prostate, with or without uSTADT.
DRUG	Ultra-Short-Term Androgen Deprivation Therapy with Relugolix	Ultra-Short-Term Androgen Deprivation Therapy (uSTADT) is hormone therapy that includes Relugolix. Patients will receive a loading dose of uSTADT for a total duration 4 weeks (28 days), with oral LHRH antagonist relugolix administered daily starting 2 weeks prior to LEAD RT and continuing until 2 weeks afterwards as per Study Calendar. Patients randomized to uSTADT will receive a loading dose of 360 mg of oral relugolix on Day 14 followed by 120 mg of oral relugolix daily from Day 13 to Day 14. Patients will be instructed to take relugolix orally once daily at approximately the same time each day. Patients may take relugolix with or without food and should swallow tablets whole and not crush or chew tablets.
RADIATION	HypoLEAD	In Hypofractionated LEAD (HypoLEAD), the multiparametric-MRI (mpMRI) defined GTV will receive 12-16 Gy in a single fraction on the first day of treatment, with or without uSTADT. Four weeks after LEAD RT, patients will begin whole prostate moderately hypoLEAD (67.5 Gy in 25 fractions) with pelvic nodal irradiation and further ADT at the discretion of the treating physician.
DRUG	ADT Standard of Care	Participants will receive ADT as per standard of care (SOC).

Timeline

• Start date: 2024-11-06
• Primary completion: 2028-11-30
• Completion: 2033-11-30
• First posted: 2023-11-01
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study