The University of Miami Adapt (UAdapt) Trial

NCT06111313 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: 20230097
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prostate cancer research study is to investigate:

1. 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. 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. 3.The ability of a single session of high dose SBRT to activate your immune system to enhance eradication of prostate cancer;
4. 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. 5.The relationship between diagnostic imaging studies and prostate biopsy results in assessing clinical outcomes; and
6. 6.The relationship of pre- and post-treatment prostate biopsy results and imaging studies, such as MRI and PET/CT.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Proportion of Patients with Biochemical Disease Failure (FFBN9mo)

  Biochemical Disease Failure will be determined by the proportion of patients with biochemical disease failure.

  Up to 14 Months

• Proportion of Patients with Clinical Disease Failure

  Clinical Disease Failure will be determined by the proportion of patients with clinical disease failure. Clinical disease failure will include the proportion of patients with biopsy finding of treatment failure.

  Up to 14 Months

Secondary Outcomes (4)

• Proportion of Patients with Biochemical Disease Failure (Phoenix definition)

  Up to 2.5 years

• Proportion of Patients with Clinical Disease Failure

  Up to 2.5 years

• Number of Treatment Related Acute toxicity

  Up to 3 months

• Number of Treatment Related Late toxicity

  Up to 8 Years

Study Arms (4)

Focal Therapy lattice extreme ablative dose (FTLEAD), RT Only, Arm A

EXPERIMENTAL

Participants in this group will receive the FTLEAD treatment only and will be followed for up to 5.5 years.

Radiation: FTLEAD

Focal Therapy lattice extreme ablative dose (FTLEAD), uSTADT, Arm B

EXPERIMENTAL

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.

Radiation: FTLEAD; Drug: Ultra-Short-Term Androgen Deprivation Therapy with Relugolix

Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), Arm C

EXPERIMENTAL

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.

Radiation: FTLEAD; Radiation: HypoLEAD; Drug: ADT Standard of Care

Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), uSTADT, Arm D

EXPERIMENTAL

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.

Radiation: FTLEAD; Drug: Ultra-Short-Term Androgen Deprivation Therapy with Relugolix; Radiation: HypoLEAD; Drug: ADT Standard of Care

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.

Focal Therapy lattice extreme ablative dose (FTLEAD), RT Only, Arm A; Focal Therapy lattice extreme ablative dose (FTLEAD), uSTADT, Arm B; Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), Arm C; Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), uSTADT, Arm D

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.

Focal Therapy lattice extreme ablative dose (FTLEAD), uSTADT, Arm B; Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), uSTADT, Arm D

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.

Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), Arm C; Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), uSTADT, Arm D

ADT Standard of Care DRUG

Participants will receive ADT as per standard of care (SOC).

Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), Arm C; Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), uSTADT, Arm D

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• Central gland: A suspicious central gland lesion on mpMRI must have a distinct lesion on the ADC map (Value \<1000).
• No previous pelvic radiotherapy.
• No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable).
• No 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.
• Ability to understand and the willingness to sign a written informed consent document.
• Zubrod performance status ≤2. Karnofsky or Eastern Cooperative Oncology Group (ECOG) performance status may be used to estimate Zubrod.
• Age ≥35 and ≤85 years at signing of consent.

You may not qualify if:

• 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.
• Thyroxine (T4) disease.
• Patients with impaired decision-making capacity who lack the ability to understand and voluntarily sign a written informed consent document.

Sponsors & Collaborators

• University of Miami: lead
• Varian Medical Systems: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

relugolix

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Benjamin Spieler, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Spieler, MD

CONTACT

305-243-4229; bxs737@med.miami.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The Miami UAdapt Trial is a non-comparative phase II study that includes two parallel randomized cohorts that will prospectively assign men radiotherapy (RT) treatment. Patients with relatively favorable risk prostate cancer (PCa) will be eligible for focal therapy LEAD (FTLEAD) RT (n=40), and randomized to receive Lattice Extreme Ablative Dose (LEAD) single high dose RT (SDRT, 12-16 Gy) vs. the same overall plan with the addition of ultrashort-term ADT (uSTADT, 1 month duration) concurrent with SDRT. Higher risk patients are assigned to the HypoLEAD cohort (n=40) and randomized 1:1 to receive Lattice Extreme Ablative Dose (LEAD) single high dose RT (SDRT, 16-20 Gy) followed by moderately hypofractionated (HypoFx) RT for 25 additional fractions vs. the same overall plan with the addition of ultrashort-term ADT (uSTADT, 1 month duration) concurrent with SDRT. In HypoLEAD additional ADT will be assigned at physician discretion per standard of care.

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: November 6, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2033
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)