Prostate CancerPhase 2NCT06111313
The University of Miami Adapt (UAdapt) Trial
A Phase 2 study testing FTLEAD, Ultra-Short-Term Androgen Deprivation Therapy with Relugolix and HypoLEAD in people with Prostate Cancer, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- FTLEAD, Ultra-Short-Term Androgen Deprivation Therapy with Relugolix and HypoLEAD
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2024to 30 Nov 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Serum testosterone is within 40% of normal assay limits (eg, x=0.4*lower assay limit and x=0.4*upper assay limit + upper assay limit), taken within (≤) 3 months of signing of consent.
- For patients in HypoLEAD cohort, post-LEAD RT androgen deprivation therapy, including use of secondary agents (eg, abiraterone), is at the discretion of the treating physician but must be declared as none, short-term or long-term prior to enrollment. Note that this ADT regimen differs from the uSTADT regimen. If antiandrogen therapy (eg, bicalutamide) or ADT (LHRH agonist or antagonist injection) is planned, the following restrictions apply:
- Anti-androgen therapy and ADT must be started after 3-week post-LEAD RT gradient biopsy.
- Anti-androgen therapy and ADT are recommended to be started prior to or concurrent with start of moderately hypofractionated RT course and must be started before the end of the hypofractionated RT course.
- The total length planned must be ≤ 30 months.
- Patient unable to receive iodine or gadolinium contrast due to allergy or poor renal function are still eligible for enrollment.
Who cannot join
- 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.
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- 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.
- Patients unable to tolerate diagnostic MRI acquisition. Note: inability to tolerate contrast agents is not exclusionary.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Benjamin Spieler, MD, 305-243-4229, bxs737@med.miami.edu
Benjamin Spieler, MD
About this study
Official title: 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
The purpose of this prostate cancer research study is to investigate:
- 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;
- 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;
- The ability of a single session of high dose SBRT to activate your immune system to enhance eradication of prostate cancer;
- 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;
- The relationship between diagnostic imaging studies and prostate biopsy results in assessing clinical outcomes; and
- The relationship of pre- and post-treatment prostate biopsy results and imaging studies, such as MRI and PET/CT.
- Conditions
- Prostate Cancer
- Being tested
- FTLEAD, Ultra-Short-Term Androgen Deprivation Therapy with Relugolix, HypoLEAD, ADT Standard of Care
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FTLEADRadiation
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 RelugolixDrug
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.
HypoLEADRadiation
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 CareDrug
Participants will receive ADT as per standard of care (SOC).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Radiation: FTLEAD; Drug: Ultra-Short-Term Androgen Deprivation Therapy with Relugolix; Radiation: HypoLEAD; Drug: ADT Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients with Biochemical Disease Failure (FFBN9mo)
Biochemical Disease Failure will be determined by the proportion of patients with biochemical disease failure.
Measured: 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.
Measured: Up to 14 Months
Secondary outcomes (4)
Proportion of Patients with Biochemical Disease Failure (Phoenix definition)
Biochemical Disease Failure will be determined by the proportion of patients with biochemical disease failure.
Measured: Up to 2.5 years
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.
Measured: Up to 2.5 years
Number of Treatment Related Acute toxicity
Acute toxicity is defined as grade 2+ and grade 3+ treatment-related acute genitourinary (GU)/gastrointestinal (GI) toxicity occurring during treatment and within 3 months of completing treatment. The severity of the reactions to treatment will be scored according to the criteria outline in CTCAE version 5.0.
Measured: Up to 3 months
Number of Treatment Related Late toxicity
Late toxicity is defined as grade 2+ and grade 3+ treatment-related GU/GI toxicity occurring more than 3 months after completing study treatment. The severity of the reactions to treatment will be scored according to the criteria outline in CTCAE version 5.0.
Measured: Up to 8 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start6 Nov 2024
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Principal investigator, Benjamin Spieler, University of Miami
- Investigators
- Benjamin Spieler, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111313
- Sponsor's protocol ID
- 20230097
- Status last verified
- Feb 2026
- First submitted
- 26 Oct 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06111313
- Acronym / sponsor ID
- 20230097
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2033 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this prostate cancer research study is to investigate:
- 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;
- 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;
- The ability of a single session of high dose SBRT to activate your immune system to enhance eradication of prostate cancer;
- 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;
- The relationship between diagnostic imaging studies and prostate biopsy results in assessing clinical outcomes; and
- The relationship of pre- and post-treatment prostate biopsy results and imaging studies, such as MRI and PET/CT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Focal Therapy lattice extreme ablative dose (FTLEAD), RT Only, Arm A | Experimental | Radiation: FTLEADParticipants in this group will receive the FTLEAD treatment only and will be followed for up to 5.5 years. |
| Focal Therapy lattice extreme ablative dose (FTLEAD), uSTADT, Arm B | Experimental | Radiation: FTLEAD, Drug: Ultra-Short-Term Androgen Deprivation Therapy with RelugolixParticipants 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. |
| Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), Arm C | Experimental | Radiation: FTLEAD, Radiation: HypoLEAD, Drug: ADT Standard of CareParticipants 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. |
| Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), uSTADT, Arm D | Experimental | Radiation: FTLEAD, Drug: Ultra-Short-Term Androgen Deprivation Therapy with Relugolix, Radiation: HypoLEAD, Drug: ADT Standard of CareParticipants 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. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FTLEADIn 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. | Radiation | 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 RelugolixUltra-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. | Drug | Focal Therapy lattice extreme ablative dose (FTLEAD), uSTADT, Arm B, Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), uSTADT, Arm D |
| HypoLEADIn 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. | Radiation | 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 CareParticipants will receive ADT as per standard of care (SOC). | Drug | Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), Arm C, Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), uSTADT, Arm D |
Primary outcome
Proportion of Patients with Biochemical Disease Failure (FFBN9mo)
Time frame: Up to 14 Months
Biochemical Disease Failure will be determined by the proportion of patients with biochemical disease failure.
Proportion of Patients with Clinical Disease Failure
Time frame: Up to 14 Months
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.
4 secondary outcomes
Proportion of Patients with Biochemical Disease Failure (Phoenix definition)
Time frame: Up to 2.5 years
Proportion of Patients with Clinical Disease Failure
Time frame: Up to 2.5 years
Number of Treatment Related Acute toxicity
Time frame: Up to 3 months
Number of Treatment Related Late toxicity
Time frame: Up to 8 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Spieler, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FTLEAD, Ultra-Short-Term Androgen Deprivation Therapy with Relugolix and HypoLEAD in people with Prostate Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Spieler, MD (305-243-4229, bxs737@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients with Biochemical Disease Failure (FFBN9mo) (time frame: Up to 14 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.