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RecruitingPhase 2

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

Assessing the Efficacy of Neoadjuvant Androgen Deprivation Therapy (ADT) Utilizing 18F-Flotufolastat PSMA PET/CT in Patients With High-Risk Localized Prostate Cancer (LHRPC)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how hormone treatment called androgen deprivation therapy (ADT) affects PSMA, a marker of prostate cancer, using PET/CT scans before and after treatment. It is for adult men with high-risk prostate cancer who can have surgery to remove the prostate. Follow-up lasts 48 months after surgery, with routine blood tests and checks for new or worsening symptoms.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a consent form before joining the study.
  • Be a man age 18 or older.
  • Be fully active or able to do light work, with limits only on hard physical activity.
  • Have prostate adenocarcinoma, a type of cancer confirmed by a tissue sample, and be able to have surgery to remove the prostate.
  • Have at least one high-risk feature: cancer stage cT3–cT4, cancer grade group 4–5 (Gleason score 8–10), or a PSA blood level above 20 ng/mL.
  • Have no lymph node spread on PSMA PET/CT scans. Some people with positive nodes may qualify based on node size; the study team must check this.
  • If having sex with someone who is pregnant or could become pregnant, agree to use a barrier method, such as a condom, plus another effective birth control method until 1 week after the scans.
  • Have blood counts of at least: hemoglobin 10.0 g/dL, neutrophils 1.8 × 10⁹/L, and platelets 100 × 10⁹/L. These measure parts of blood that carry oxygen, fight infection, and help stop bleeding.

Who can't join

  • An allergy or intolerance to the scan drug, 18F-flotufolastat, or inability to receive ADT.
  • Prostate cancer with significant neuroendocrine features or another rare cell type; or cancer spread to bones, organs, or lymph nodes above where the common iliac arteries split in the pelvis.
  • Severe kidney problems, with a kidney filtering rate below 30 mL/min, or past radiation treatment for prostate cancer.
  • Certain heart problems within 6 months before treatment: severe or unstable chest pain, heart attack, heart failure with symptoms, serious abnormal rhythms in the heart’s lower chambers, or class II–IV heart disease.
  • Severe uncontrolled high blood pressure, ongoing uncontrolled diabetes, lung disease needing oxygen, long-term liver disease, untreated HIV, or a severe or uncontrolled infection.
  • Another cancer within the past 5 years, except cured basal cell or squamous cell skin cancer; or current cell-killing cancer treatment for another cancer.
  • Unable to complete the second PSMA scan or prostate surgery required for the study.
  • Any other condition the study doctor believes would prevent participation.

Simplified for readability. The official criteria below are what the study team uses.

Official 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. 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 sites (1)

FL