Study on the Role of rhPSMA-7.3 PET/CT Imaging in Men with High-Risk Prostate Cancer After Conventional Imaging and Its Impact on Treatment Decisions

Sponsor: MidLantic Urology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05799248

This study is exploring how a new imaging technique, rhPSMA-7.3 PET/CT, can help detect cancer spread in men with high-risk prostate cancer and how it might change their treatment plans.

Patient Parameters

Program Overview

This Phase 3b study is investigating the use of rhPSMA-7.3 PET/CT imaging to find cancer that has spread in men with high-risk prostate cancer. The study aims to see if this imaging method can provide more accurate information than standard imaging tests, which could lead to changes in how doctors manage and treat the cancer.

Description

Men who agree to participate in this study will first be checked to see if they qualify. As part of their regular medical care, they will have standard imaging tests like bone scans and CT or MRI scans. Before any major treatments like surgery or radiation, they will receive an injection of rhPSMA-7.3, followed by a PET scan. The results of this scan will be shared with their doctor before any treatment decisions are made. If the scan shows that the cancer has spread, further tests like biopsies or additional imaging may be needed to confirm this before starting treatment. The study's goal is to see if this new imaging method can better detect cancer spread and help doctors choose the best treatment plan for patients with high-risk prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Men aged over 18 years.
  • Confirmed diagnosis of prostate cancer.
  • Classified as high-risk prostate cancer, which includes having a high Gleason score, high PSA levels, or advanced cancer stage.
  • Willing to sign a consent form and follow the study procedures.

Exclusion Criteria

  • Any medical condition that might affect the study results or the patient's ability to follow the study.
  • Planned use of certain imaging agents within 24 hours before the PET scan.
  • Current or past use of hormone therapy for prostate cancer.
  • Participation in another clinical trial within the last 30 days or recent use of investigational drugs.

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