Using rhPSMA-7.3 PET/CT imaging to improve treatment for men with high-risk prostate cancer

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

This study is testing a new imaging technique to see if it can better find cancer spread in men with high-risk prostate cancer before they start treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 113 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: MidLantic Urology (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Bala-Cynwyd, Pennsylvania)
• Trial ID: NCT05799248 on ClinicalTrials.gov

What this trial studies

This Phase 3b clinical trial evaluates the effectiveness of rhPSMA-7.3 PET/CT imaging in detecting metastatic lesions in men diagnosed with high-risk prostate cancer. Participants will undergo conventional imaging followed by an intravenous injection of rhPSMA-7.3, after which PET imaging will be performed. The results will inform medical management decisions prior to planned treatments such as surgery or radiation therapy. The study aims to assess the accuracy of this imaging technique compared to standard methods and its impact on treatment strategies.

Who should consider this trial

Good fit: Ideal candidates are men over 18 years old with histologically confirmed high-risk prostate cancer.

Not a fit: Patients with prior androgen deprivation therapy or those with conditions that may compromise data collection may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate detection of metastatic prostate cancer, allowing for better-informed treatment decisions.

How similar studies have performed: Other studies have shown promising results with advanced imaging techniques in cancer detection, suggesting potential for success in this approach.

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.

Where this trial is running

Bala-Cynwyd, Pennsylvania

• MidLantic Urology — Bala-Cynwyd, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Laurence Belkoff, DO, FACOS — MidLantic Urology
• Study coordinator: Cheryl Zinar, RN,BSN

Conditions Prostate Cancer