Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT

Baptist Health South Florida

Status and phase

Begins enrollment this month

Phase 2

Conditions

Localized Prostate Carcinoma

Prostate Cancer

Treatments

Drug: Triptorelin

Drug: Degarelix

Drug: Bicalutamide

Drug: Relugolix

Procedure: Radical prostatectomy

Drug: Leuprolide

Diagnostic Test: 18-F Flotufolastat PSMA PET

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07455903

2025-GAR-001

Details and patient eligibility

About

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).

Full 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.

Enrollment

50 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

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

Experimental group

Description:

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.