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

About This Trial

This study is testing how effective hormone therapy is when given before surgery to treat prostate cancer, using a specialized imaging scan to see how the tumor responds.
It is open to adults with high-risk prostate cancer that has not spread to other parts of the body and who are planning to have their prostate surgically removed.
If you take part, you will receive hormone treatment, undergo special scans, and proceed with standard surgery to remove the prostate.
You should also know that participation requires follow-up visits and blood tests for up to four years to monitor your health, and individuals with certain severe heart or kidney conditions may not be eligible.

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 (Standard of Care).

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study is testing how effective hormone therapy is when given before surgery to treat prostate cancer, using a specialized imaging scan to see how the tumor responds.

Full Eligibility Criteria

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.
- cT3-cT4
- 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

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.