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

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).

Eligibility

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.

Conditions3

Interventions5

Locations1 site

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