Prostate CancerPhase 2NCT07455903
Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
A Phase 2 study testing Leuprolide, Degarelix and Relugolix in people with Prostate Cancer and Localized Prostate Carcinoma, run by Baptist Health South Florida at 1 site in United States.
Trial summary
The purpose of this research study is to test the efficacy of ADT on prostate-specific membrane antigen (PSMA), a marker of prostate cancer, before and after scheduled ADT. Follow up will be 48 months your prostate removal to do a blood test and log if any new or worsening symptoms have occurred as a part of your… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Localized Prostate Carcinoma
- What is being tested?
- Leuprolide, Degarelix and Relugolix
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2026to Feb 2031
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained prior to participation in the study.
- Males aged ≥18 years.
- ECOG performance status ≤ 1
- Histologically confirmed adenocarcinoma of the prostate in a patient amenable to radical prostatectomy
- Pathologically proven prostate adenocarcinoma with ≥ 1 High-risk feature based on NCCN guidelines.
- cT3-cT4
Show all 14Show fewer
- International Society of Urological Pathology (ISUP) Grade group 4 (Gleason score 8) or grade group 5 (Gleason score 9-10)
- PSA >20 ng/mL
- Clinically negative lymph nodes as established by PSMA PET/CT imaging. Patients who are node positive by PSMA PET/CT (e.g., N1), but whose nodes do not meet traditional size criteria for positivity (e.g., they measure ≥ 10mm on either the CT or MRI portion of the PET or on a dedicated CT or MRI) will not be considered N1 and would be eligible for this study.
- Patient is willing to use barrier-method of contraception along with another effective contraceptive method if engaged in sexual activity with a pregnant person or individual of childbearing potential (until 1 week after completing 18F-flotufolastat PSMA PET/CT Scans.
- Clinical laboratory values during screening:
- Hemoglobin ≥ 10.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.8 × 10⁹/L
- Platelets ≥ 100 × 10⁹/L
Who cannot join
- Known allergies, hypersensitivity, or intolerance to 18F-flotufolastat.
- Unable to receive androgen deprivation therapy.
- Prostate cancer with significant neuroendocrine or other rare variant pathology
- Evidence of metastatic disease involving bone, viscera, or lymph nodes superior to the bifurcation of the common iliac arteries on PSMA PET/CT
- Renal impairment (glomerular filtration rate <30 mL/min)
- History of prior radiation therapy for prostate cancer
Show all 14Show fewer
- Any of the following within 6 months prior to the first dose of study treatment: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, clinically significant ventricular arrhythmias, or New York Heart Association Class II to IV heart disease.
- Uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or untreated HIV infection.
- Other malignancies other than prostate cancer in the past 5 years
- Cured basal cell or squamous cell skin cancers can be enrolled.
- Severe or uncontrolled concurrent infections are not eligible.
- Treated with concomitant cytotoxic cancer therapy for any other primary site.
- Patients who are unable to complete the study requirements of 2nd PSMA imaging or surgery for the primary endpoints.
- Any condition that, in the opinion of the investigator, would preclude participation in this study.
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
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
Rohan Garje, MD, 786-596-2000, rohan.garje@baptisthealth.net
About this study
Official title: Assessing the Efficacy of Neoadjuvant Androgen Deprivation Therapy (ADT) Utilizing 18F-Flotufolastat PSMA PET/CT in Patients With High-Risk Localized Prostate Cancer (LHRPC)
The purpose of this research study is to test the efficacy of ADT on prostate-specific membrane antigen (PSMA), a marker of prostate cancer, before and after scheduled ADT. Follow up will be 48 months your prostate removal to do a blood test and log if any new or worsening symptoms have occurred as a part of your standard-of-care (SOC).
Read the detailed description
This is a single-arm, phase II, open label study in patients with localized high- risk prostate cancer (LHRPC) treated with neoadjuvant ADT (leuprolide, degarelix, relugolix, or triptorelin) followed by radical prostatectomy (RP). This study aims to evaluate the efficacy of neoadjuvant ADT based on maximal standardized uptake value (SUVmax) changes on 18F-Flotufolastat prostate- specific membrane antigen (PSMA) PET/CT scan in patients with LHRPC. Additionally, it will investigate the prognostic value of SUVmax changes in predicting biochemical recurrence-free survival.
- Conditions
- Prostate Cancer, Localized Prostate Carcinoma
- Being tested
- Leuprolide, Degarelix, Relugolix, Triptorelin, Bicalutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeuprolideDrug
Also called Lupron, Eligard
22.5 mg IM every 3 months × 2 doses
DegarelixDrug
Also called Firmagon
240 mg SC loading dose, then 80 mg SC q28 days × 6 months
RelugolixDrug
Also called Orgovyx
360 mg PO Day 1, then 120 mg PO daily × 6 months
TriptorelinDrug
Also called Trelstar
11.25 mg IM every 3 months × 2 doses
BicalutamideDrug
Also called Casodex
Given only with leuprolide or triptorelin; 50 mg PO daily for 30 days
18-F Flotufolastat PSMA PETDiagnostic test
Also called Posluma
296 MBq (8mCi) administered as an intravenous bolus injection prior to PSMA PET scan. May be administered diluted in normal saline (NS) or undiluted. The maximum volume of undiluted 18F-flotufolastat is 5mL. After administration, a flush with 0.9% NS will be given to ensure full delivery of the dose.
Radical prostatectomyProcedure or surgery
Surgery to occur 14 to 90 days after the pre-surgery visit. All RPs will be performed per institutional standard of care by fellowship-trained urologic oncologists, with an extended pelvic lymph-node dissection when clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP) | Experimental | Participants will be prescribed one of four ADTs, administered over two treatment cycles spaced three months apart.
* Leuprolide: Administered by a Health Care Practitioner (HCP), injecting the drug into the muscle every 3 months for 6 months total.
* Degarelix: Administered by a HCP, injecting the drug under your skin every 28 days for 6 months.
* Relugolix: Self-administered orally (pill), once daily for 6 months.
* Triptorelin: Administered by a HCP, injecting the drug into the muscle every 3 months for 6 months total.
Note: For those who receive leuprolide or triptorelin, bicalutamide also will be prescribed to take daily for 30 days starting from Day 1 of receiving leuprolide or triptorelin.
All participants will receive a PET using 18F-flotufolastat at baseline and after 6 months of treatment with ADT.
All participants will receive radical prostatectomy after the second 18F-flotufolastat PET scan. Receives: Drug: Leuprolide; Drug: Degarelix; Drug: Relugolix; Drug: Triptorelin; Drug: Bicalutamide; Diagnostic Test: 18-F Flotufolastat PSMA PET; Procedure: Radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) based on PSMA PET
ORR is based on changes in maximum standard uptake value (SUVmax) on PSMA PET/CT imaging pre- and post-ADT. Complete response (CR) is defined as resolution of all PSMA-avid lesions. Partial response (PR) is defined as >30% decrease in SUVmax. Progressive disease (PD) is defined as >30% increase in SUVmax or presence of new PSMA-avid lesions. Stable disease (SD) is defined as not meeting criteria for CR, PR, or PD. ORR is defined as the proportion of participants having CR or PR after ADT based on SUVmax.
Measured: 6 Months
ORR based on Response Evaluation Criteria in PSMA Imaging (RECIP 1.0)
ORR in this endpoint is based on RECIP 1.0 criteria. Complete response (CR) is defined as disappearance of all PSMA-avid disease. Partial response (PR) is defined as ≥30% increase in total tumor volume. Progressive disease (PD) is defined as ≥20% increase in total tumor volume or presence of new PSMA-avid lesions. Stable disease (SD) is defined as not meeting criteria for CR, PR, or PD. ORR is defined as the proportion of participants having CR or PR after ADT based on RECIP 1.0.
Measured: 6 Months
Secondary outcomes (2)
Prostate-Specific Antigen (PSA) response rate
Defined as the proportion of participants with a PSA reduction of at least 50% (PSA50) immediately prior to RP compared with baseline PSA after treatment with ADT.
Measured: 36 Months
Biochemical recurrence-free survival (BCR) with testosterone recovery
BCR with testosterone recovery is defined as the time from ADT initiation to PSA ≥0.2 ng/mL after RP once testosterone has normalized. Median times will be calculated for responders (CR and PR) and non-responders (SD and PD).
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start29 Jul 2026
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2031 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Sponsor
- Investigators
- Rohan Garje, M.D., Principal investigator, Miami Cancer Institute at Baptist Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455903
- Sponsor's protocol ID
- 2025-GAR-001
- Status last verified
- Jul 2026
- First submitted
- 3 Mar 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Neoadjuvant Androgen Deprivation Therapy (ADT) Utilizing 18F-Flotufolastat PSMA PET/CT in Patients With High-Risk Localized Prostate Cancer (LHRPC)
- ClinicalTrials.gov ID
- NCT07455903
- Acronym / sponsor ID
- 2025-GAR-001
- Conditions
- Prostate Cancer, Localized Prostate Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 6 Mar 2026 (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 research study is to test the efficacy of ADT on prostate-specific membrane antigen (PSMA), a marker of prostate cancer, before and after scheduled ADT. Follow up will be 48 months your prostate removal to do a blood test and log if any new or worsening symptoms have occurred as a part of your standard-of-care (SOC).
Detailed description
This is a single-arm, phase II, open label study in patients with localized high- risk prostate cancer (LHRPC) treated with neoadjuvant ADT (leuprolide, degarelix, relugolix, or triptorelin) followed by radical prostatectomy (RP). This study aims to evaluate the efficacy of neoadjuvant ADT based on maximal standardized uptake value (SUVmax) changes on 18F-Flotufolastat prostate- specific membrane antigen (PSMA) PET/CT scan in patients with LHRPC. Additionally, it will investigate the prognostic value of SUVmax changes in predicting biochemical recurrence-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP) | Experimental | Drug: Leuprolide, Drug: Degarelix, Drug: Relugolix, Drug: Triptorelin, Drug: Bicalutamide, Diagnostic Test: 18-F Flotufolastat PSMA PET, Procedure: Radical prostatectomyParticipants will be prescribed one of four ADTs, administered over two treatment cycles spaced three months apart. * Leuprolide: Administered by a Health Care Practitioner (HCP), injecting the drug into the muscle every 3 months for 6 months total. * Degarelix: Administered by a HCP, injecting the drug under your skin every 28 days for 6 months. * Relugolix: Self-administered orally (pill), once daily for 6 months. * Triptorelin: Administered by a HCP, injecting the drug into the muscle every 3 months for 6 months total. Note: For those who receive leuprolide or triptorelin, bicalutamide also will be prescribed to take daily for 30 days starting from Day 1 of receiving leuprolide or triptorelin. All participants will receive a PET using 18F-flotufolastat at baseline and after 6 months of treatment with ADT. All participants will receive radical prostatectomy after the second 18F-flotufolastat PET scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed informed consent must be obtained prior to participation in the study.
- Males aged ≥18 years.
- ECOG performance status ≤ 1
- Histologically confirmed adenocarcinoma of the prostate in a patient amenable to radical prostatectomy
- Pathologically proven prostate adenocarcinoma with ≥ 1 High-risk feature based on NCCN guidelines.
Key exclusion criteria (14 listed)
- Known allergies, hypersensitivity, or intolerance to 18F-flotufolastat.
- Unable to receive androgen deprivation therapy.
- Prostate cancer with significant neuroendocrine or other rare variant pathology
- Evidence of metastatic disease involving bone, viscera, or lymph nodes superior to the bifurcation of the common iliac arteries on PSMA PET/CT
- Renal impairment (glomerular filtration rate <30 mL/min)
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 |
|---|---|---|
| LeuprolideAlso: Lupron, Eligard22.5 mg IM every 3 months × 2 doses | Drug | Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP) |
| DegarelixAlso: Firmagon240 mg SC loading dose, then 80 mg SC q28 days × 6 months | Drug | Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP) |
| RelugolixAlso: Orgovyx360 mg PO Day 1, then 120 mg PO daily × 6 months | Drug | Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP) |
| TriptorelinAlso: Trelstar11.25 mg IM every 3 months × 2 doses | Drug | Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP) |
| BicalutamideAlso: CasodexGiven only with leuprolide or triptorelin; 50 mg PO daily for 30 days | Drug | Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP) |
| 18-F Flotufolastat PSMA PETAlso: Posluma296 MBq (8mCi) administered as an intravenous bolus injection prior to PSMA PET scan. May be administered diluted in normal saline (NS) or undiluted. The maximum volume of undiluted 18F-flotufolastat is 5mL. After administration, a flush with 0.9% NS will be given to ensure full delivery of the dose. | Diagnostic test | Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP) |
| Radical prostatectomySurgery to occur 14 to 90 days after the pre-surgery visit. All RPs will be performed per institutional standard of care by fellowship-trained urologic oncologists, with an extended pelvic lymph-node dissection when clinically indicated. | Procedure or surgery | Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP) |
Primary outcome
Objective response rate (ORR) based on PSMA PET
Time frame: 6 Months
ORR is based on changes in maximum standard uptake value (SUVmax) on PSMA PET/CT imaging pre- and post-ADT. Complete response (CR) is defined as resolution of all PSMA-avid lesions. Partial response (PR) is defined as >30% decrease in SUVmax. Progressive disease (PD) is defined as >30% increase in SUVmax or presence of new PSMA-avid lesions. Stable disease (SD) is defined as not meeting criteria for CR, PR, or PD. ORR is defined as the proportion of participants having CR or PR after ADT based on SUVmax.
ORR based on Response Evaluation Criteria in PSMA Imaging (RECIP 1.0)
Time frame: 6 Months
ORR in this endpoint is based on RECIP 1.0 criteria. Complete response (CR) is defined as disappearance of all PSMA-avid disease. Partial response (PR) is defined as ≥30% increase in total tumor volume. Progressive disease (PD) is defined as ≥20% increase in total tumor volume or presence of new PSMA-avid lesions. Stable disease (SD) is defined as not meeting criteria for CR, PR, or PD. ORR is defined as the proportion of participants having CR or PR after ADT based on RECIP 1.0.
2 secondary outcomes
Prostate-Specific Antigen (PSA) response rate
Time frame: 36 Months
Biochemical recurrence-free survival (BCR) with testosterone recovery
Time frame: 36 months
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 6 Aug 2026.
- Miami Cancer InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Rohan Garje, M.D. principal investigator
Miami Cancer Institute at Baptist Health, Inc.
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 Leuprolide, Degarelix and Relugolix in people with Prostate Cancer and Localized Prostate Carcinoma, run by Baptist Health South Florida 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 14 inclusion and 14 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 6 Aug 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 Rohan Garje, M.D. (786-596-2000, rohan.garje@baptisthealth.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) based on PSMA PET (time frame: 6 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 6 Aug 2026.