Role of rhPSMA-7.3 PET/CT Imaging in Men With High-Risk Prostate Cancer Following Conventional Imaging and Associated Changes in Medical Management

Launched by MIDLANTIC UROLOGY · Mar 22, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new imaging technique called rhPSMA-7.3 PET/CT to help detect areas of prostate cancer that may have spread in men who are considered high-risk. High-risk prostate cancer can be identified by certain factors, such as specific grades of cancer cells or higher levels of a protein called PSA. The study aims to see if this advanced imaging can provide important information that helps doctors make better treatment decisions for these patients.

To participate in the trial, men must be over 18 years old and have a confirmed diagnosis of high-risk prostate cancer. Participants will undergo the rhPSMA-7.3 PET/CT imaging, and they should be willing to follow the study schedule and provide informed consent. However, individuals who have certain medical conditions or who are currently receiving specific cancer treatments may not be eligible. Throughout the trial, participants can expect close monitoring and to contribute valuable information that may improve future prostate cancer care.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient willing to provide signed informed consent and willing to comply with all required study schedule events, where safe and feasible.
• • 2. Patient is male and aged \>18 years old.
• • 3. Histologically confirmed adenocarcinoma of the prostate.
• • 4. High risk prostate cancer. High-risk patients will be defined as having any of the following criteria: primary Gleason grade 4, or any Gleason grade 5, PSA ≥20, or clinical stage T3a (per NCCN Guidelines Version 2.2019; PROS-2).
• Exclusion Criteria:
• • 1. Patients with any medical condition or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements.
• • 2. Patients who are planned to have an x-ray contrast agent or other PET radiotracer \<24 hours prior to the PET scan.
• • 3. Patients currently receiving, or with a prior history of, androgen deprivation therapy (ADT; defined as surgical orchidectomy; luteinizing hormone-releasing hormone \[LHRH\] agonist alone \[continuous or intermittent\]; LHRH antagonist alone \[continuous or intermittent\]; administration or use of a first generation or second generation anti-androgen alone or in combination with an LHRH agonist/antagonist).
• • 4. Patients participating in an interventional clinical trial within 30 days and having received an IP within five biological half-lives prior to administration of rhPSMA-7.3.