The University of Miami Adapt (UAdapt) Trial

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06111313
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
35 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • FTLEAD — RADIATION
    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.
  • Ultra-Short-Term Androgen Deprivation Therapy with Relugolix — DRUG
    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.
  • HypoLEAD — RADIATION
    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.
  • ADT Standard of Care — DRUG
    Participants will receive ADT as per standard of care (SOC).

Study Details

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.

Key Dates

Start date
Nov 6, 2024
Status verified
Feb 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2033

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Focal Therapy lattice extreme ablative dose (FTLEAD), RT Only, Arm A
    Participants in this group will receive the FTLEAD treatment only and will be followed for up to 5.5 years.
  • Experimental: Focal Therapy lattice extreme ablative dose (FTLEAD), uSTADT, Arm B
    Participants in this group will receive the FTLEAD treatment and ultra short-term androgen deprivation therapy (ADT) and will be followed for up to 5.5 years.
  • Experimental: Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), Arm C
    Participants in this group will receive LEAD RT followed by moderately hypofractionated RT (HypoLEAD) and standard of care androgen deprivation therapy and will be followed for 5.5-8 years.
  • Experimental: Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), uSTADT, Arm D
    Participants in this group will receive LEAD RT with ultra short-term ADT followed by moderately hypofractionated RT (HypoLEAD) and standard of care ADT and will be followed for 5.5-8 years.

Primary Outcome Measure

Proportion of Patients with Biochemical Disease Failure (FFBN9mo) [ Time Frame: Up to 14 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Benjamin Spieler, MD
[email protected]
305-243-4229
Benjamin Spieler, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Miami· Miami, FL

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