Recruiting
Phase 2

ADT

Sponsor:

Baptist Health South Florida

Code:

NCT07455903

Conditions

Prostate Cancer

Localized Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Leuprolide

Degarelix

Relugolix

Triptorelin

Bicalutamide

Study Details

Brief 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 standard-of-care (SOC).

Conditions

Prostate Cancer

Localized Prostate Carcinoma

Study ID

NCT07455903

Start date

Jul 29, 2026

Status verified date

Jul, 2026

Completion date

Feb, 2031

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

1. cT3-cT4
2. International Society of Urological Pathology (ISUP) Grade group 4 (Gleason score 8) or grade group 5 (Gleason score 9-10)
3. 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:

1. Hemoglobin ≥ 10.0 g/dL
2. Absolute neutrophil count (ANC) ≥ 1.8 × 10⁹/L
3. Platelets ≥ 100 × 10⁹/L

Exclusion Criteria:

  • 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
  • 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

a. 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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP)

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.

Interventions

Leuprolide

22.5 mg IM every 3 months × 2 doses

Degarelix

240 mg SC loading dose, then 80 mg SC q28 days × 6 months

Relugolix

360 mg PO Day 1, then 120 mg PO daily × 6 months

Triptorelin

11.25 mg IM every 3 months × 2 doses

Bicalutamide

Given only with leuprolide or triptorelin; 50 mg PO daily for 30 days

18-F Flotufolastat PSMA PET

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 prostatectomy

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.

Primary outcome measure

  • Objective response rate (ORR) based on PSMA PET [ Time Frame: 6 Months ]
  • ORR based on Response Evaluation Criteria in PSMA Imaging (RECIP 1.0) [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Rohan Garje, M.D.

786-596-2000rohan.garje@baptisthealth.net

Locations

Miami Cancer Institute at Baptist Health, Inc.

Recruiting

Miami, Florida, United States, 33176

Contacts

Rohan Garje, MD

786-596-2000rohan.garje@baptisthealth.net

More Information

Sponsor

Baptist Health South Florida

Last update posted

Aug 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baptist Health South Florida on 2026-08-06.