Study on the Effectiveness of Hormone Therapy Before Surgery in High-Risk Prostate Cancer Using a Special PET/CT Scan

Sponsor: Baptist Health South Florida

Sponsor score: 0

ClinicalTrials ID:NCT07455903

Provider View

This clinical trial is testing how well hormone therapy works in treating high-risk prostate cancer by using a special PET/CT scan to track changes in a cancer marker before and after treatment. Participants will be monitored for 48 months after prostate removal to check for any new or worsening symptoms.

Patient Parameters

Program Overview

The study aims to see how effective hormone therapy (ADT) is in treating high-risk prostate cancer by using a special PET/CT scan that looks at a cancer marker called PSMA. The trial will involve hormone therapy followed by prostate surgery. Researchers will track changes in the cancer marker to see if it can predict how long patients stay free from cancer returning.

Description

This study involves patients with high-risk prostate cancer who will receive hormone therapy (ADT) before undergoing prostate surgery. The hormone therapy options include leuprolide, degarelix, relugolix, or triptorelin. The study will use a special PET/CT scan to measure changes in a cancer marker called PSMA. The goal is to see if these changes can predict how long patients remain free from cancer returning after treatment. Participants will be followed for 48 months after surgery to monitor their health and any new symptoms.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed consent to participate.
  • Men aged 18 years or older.
  • Good overall health with a performance status of 0 or 1.
  • Confirmed diagnosis of prostate cancer eligible for surgery.
  • High-risk prostate cancer features, such as:
    • Tumor stage cT3-cT4
    • High Gleason score (8-10)
    • PSA level over 20 ng/mL
  • No cancer spread to lymph nodes as shown by PET/CT scan.
  • Willing to use effective contraception if sexually active with a partner who is pregnant or could become pregnant.
  • Meet specific blood test criteria for hemoglobin, neutrophil count, and platelets.

Exclusion Criteria

  • Allergic or intolerant to the special PET/CT scan substance.
  • Unable to undergo hormone therapy.
  • Prostate cancer with rare or neuroendocrine features.
  • Cancer spread to bones, organs, or certain lymph nodes.
  • Severe kidney problems.
  • Previous radiation therapy for prostate cancer.
  • Recent severe heart problems or heart disease.
  • Uncontrolled high blood pressure, diabetes, lung disease, liver disease, or untreated HIV.
  • Other cancers in the past 5 years, except for certain skin cancers.
  • Severe infections or other serious health issues.
  • Unable to complete required scans or surgery.
  • Any condition that the study doctor believes would prevent participation.

Locations

FACILITYZIPCITYSTATE
Miami Cancer Institute at Baptist Health, Inc.33176MiamiFlorida

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