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

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-27
• Study Completion Date: 2024-05-28

Brief 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

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

rhPSMA-7.3 (18F)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Blue Earth Diagnostics

INDUSTRY

Sponsor Role: collaborator

MidLantic Urology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurence Belkoff, DO, FACOS

Role: PRINCIPAL_INVESTIGATOR

MidLantic Urology

Locations

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cheryl Zinar, RN,BSN

Role: CONTACT

czinar@midlanticurology.com

610-667-0458

Facility Contacts

Cheryl Zinar, RN, BSN

Role: primary

czinar@midlanticurology.com

610-667-0458

Other Identifiers

BED-IIT-437

Identifier Type: -

Identifier Source: org_study_id