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

NCT05799248 | Recruiting Phase 3 FDA Drug

• 1 other identifier: BED-IIT-437
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Verified Detection Rate of rhPSMA-7.3

  15 months

• Positive predictive value of rhPSMA-7.3

  15 months

• Metastasis detection rate

  15 months

• Metastasis detection rate with negative imaging

  15 months

• Positive predictive value of rhPSMA compared to biopsy

  15 months

Study Arms (1)

rhPSMA-7.3

EXPERIMENTAL

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)

Interventions

rhPSMA-7.3 (18F) 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.

Also known as: radiohybrid PSMA-targeted PET imaging agent, Radioligand for PET CT scanning

rhPSMA-7.3

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient willing to provide signed informed consent and willing to comply with all required study schedule events, where safe and feasible.
• Patient is male and aged \>18 years old.
• Histologically confirmed adenocarcinoma of the prostate.
• 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).

You may not qualify if:

• 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.
• Patients who are planned to have an x-ray contrast agent or other PET radiotracer \<24 hours prior to the PET scan.
• 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).
• 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.

Sponsors & Collaborators

• MidLantic Urology: lead
• Blue Earth Diagnostics: collaborator

Study Sites (1)

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Laurence Belkoff, DO, FACOS

  MidLantic Urology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheryl Zinar, RN,BSN

CONTACT

610-667-0458; czinar@midlanticurology.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: role of rhPSMA-7.3 in PET/CT

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: April 5, 2023
• Study Start: April 27, 2023
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

US (1)