Recruiting
Phase 3

rhPSMA-7.3

Sponsor:

MidLantic Urology

Code:

NCT05799248

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

rhPSMA-7.3 (18F)

Study Details

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

Study ID

NCT05799248

Start date

Apr 27, 2023

Status verified date

May, 2024

Completion date

May 28, 2024

Anticipated

Primary completion date

May 28, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

113 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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.

Primary outcome measure

  • Prostate cancer upstaging [ Time Frame: 15 months ]

Central Contacts and Locations

Central contacts

Locations

MidLantic Urology

Recruiting

Bala-Cynwyd, Pennsylvania, United States, 19004

Contacts

Principal Investigator:

Laurence Belkoff, DO

More Information

Sponsor

MidLantic Urology

Last update posted

May 24, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by MidLantic Urology on 2024-05-24.