The University of Miami Adapt (UAdapt) Trial

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

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).

Sponsors & Collaborators

• Varian Medical Systems

  collaborator INDUSTRY

• University of Miami

  lead OTHER

Principal Investigators

• Benjamin Spieler, MD · University of Miami

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

85 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-06

Primary Completion

2028-11-30

Completion

2033-11-30

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations