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

Trial 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

NCT ID: NCT05799248

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: role of rhPSMA-7.3 in PET/CT

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: rhPSMA-7.3 (18F)
Description: 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.
Arm group label: rhPSMA-7.3

Other name: radiohybrid PSMA-targeted PET imaging agent, Radioligand for PET CT scanning

Summary: 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.

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

Criteria for 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.

Gender: Male

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: MidLantic Urology

Address:
City: Bala-Cynwyd
Zip: 19004
Country: United States

Status: Recruiting

Contact:
Last name: Cheryl Zinar, RN, BSN

Phone: 610-667-0458
Email: czinar@midlanticurology.com

Investigator:
Last name: Laurence Belkoff, DO
Email: Principal Investigator

Investigator:
Last name: Zachariah Taylor, DO
Email: Sub-Investigator

Start date: April 27, 2023

Completion date: May 28, 2024

Lead sponsor:
Agency: MidLantic Urology
Agency class: Other

Collaborator:
Agency: Blue Earth Diagnostics
Agency class: Industry

Source: MidLantic Urology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05799248