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

Study Title: Role of rhPSMA-7.3 PET/CT imaging in men with High-Risk prostate cancer following conventional imaging and associated changes in medical management Protocol number: BED-IIT-437 Phase: 3b Sponsor: MidLantic Urology Funding Organization: Blue Earth Diagnostics Ltd Study Design: This is a Phase 3b, multi-center, single-arm, diagnostic imaging study designed to detect metastatic lesions in men diagnosed with high-risk prostate cancer.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: rhPSMA-7.3 (18F)

Detailed Description

Consented patients will be screened to determine eligibility for the study prior to investigational product (IP) administration. In addition to their routine clinical work-up, which will include 99mtechnetium-biphosphonate bone scan and abdominal/pelvic computed tomography (CT) or magnetic resonance imaging (MRI) and chest CT per local practice, and before the scheduled radical prostatectomy (RP) and pelvic lymph node dissection (PLND), or radical pelvic radiation therapy, patients will receive 8 mCi (296 MBq) ± 20% rhPSMA-7.3, delivered as an intravenous (IV) bolus injection, followed by PET imaging. For each patient, the PET imaging results will be reported to the responsible physician prior to the planned treatment. Imaging results and further procedures/treatment plan should be discussed with the patient within 7 days after rhPSMA-7.3 imaging (this may be conducted by telephone at the clinician's discretion). Within 45 days post-IP administration, the patient will receive treatment as follows:

• Standard of care surgical treatment of PCa, including PLND; or

• If the rhPSMA-7.3 PET scan detects M1 lesion(s):

  • A biopsy/surgery and/or additional imaging to confirm M1 lesion(s) will be required prior to initiation of treatment.

The purpose of this study is to assess the accuracy of rhPSMA-7.3 PET/CT with conventional imaging for detecting metastatic disease in men with high-risk prostate cancer and the impact on medical management of these men. Accurate staging of newly diagnosed PCa assists in directing appropriate treatment strategies. In patients with high-risk PCa, the primary goal of imaging is to detect extra-prostatic disease. The identification of metastatic disease may significantly change the planned treatment regimen from locoregional to systemic therapy

• Study Type: Interventional
• Enrollment (Estimated): 113
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Cheryl Zinar, RN,BSN; Phone Number: 610-667-0458; Email: czinar@midlanticurology.com

Study Locations

• United States
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Recruiting
      • MidLantic Urology
      • Contact: Cheryl Zinar, RN, BSN; Phone Number: 610-667-0458; Email: czinar@midlanticurology.com
      • Principal Investigator: Laurence Belkoff, DO
      • Sub-Investigator: Zachariah Taylor, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rhPSMA-7.3; Role of rhPSMA-7.3 PET/CT imaging in men with High-Risk prostate cancer following conventional imaging and associated changes in medical management	Drug: rhPSMA-7.3 (18F); Patients will receive a dose with an administered activity of 8 mCi (296 MBq) ± 20% of rhPSMA-7.3, delivered as an IV bolus injection with a 10 mL fast 0.9% sodium chloride flush, followed by PET imaging.; Other Names: radiohybrid PSMA-targeted PET imaging agent, Radioligand for PET CT scanning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prostate cancer upstaging	Compare the accuracy of rhPSMA-7.3 PET/CT with conventional imaging for detecting metastatic disease and up-staging of disease in men with high-risk prostate cancer	15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verified Detection Rate of rhPSMA-7.3	To assess the Verified Detection Rate (VDR) for M1 disease of rhPSMA-7.3 PET/CT findings (as determined by central BIE) on a patient level in with high-risk prostate cancer	15 months
Positive predictive value of rhPSMA-7.3	To assess the VDR and determine PPV for M1 disease of rhPSMA-7.3 PET/CT findings (as determined by central BIE) on a patient level in patients with negative conventional imaging	15 months
Metastasis detection rate	Percentage of patients in which rhPSMA-7.3 PET/CT imaging detects at least one verified M1 metastasis, as determined by central BIE	15 months
Metastasis detection rate with negative imaging	Percentage of patients with negative conventional imaging for M1 disease in whom rhPSMA-7.3 PET/CT detects at least one verified M1 metastasis, as determined by central BIE	15 months
Positive predictive value of rhPSMA compared to biopsy	The PPV of rhPSMA-7.3 PET/CT to detect distant disease compared to biopsy in those patients who undergo a distant disease biopsy on the basis of a rhPSMA-7.3 PET/CT finding or in case of bony disease a correlation with MRI or biopsy	15 months

Collaborators and Investigators

• Sponsor: MidLantic Urology
• Collaborators: Blue Earth Diagnostics
• Investigators: Principal Investigator: Laurence Belkoff, DO, FACOS, MidLantic Urology

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2023
• Primary Completion (Estimated): May 28, 2024
• Study Completion (Estimated): May 28, 2024

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: BED-IIT-437

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No