Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence

Blue Earth Diagnostics

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: rhPSMA-7.3 (18F) Injection; Diagnostic Test: Positron emission tomography scan

Study type: Interventional

Funder types: Industry

Identifiers

NCT04186845

BED-PSMA-302

Details and patient eligibility

About

A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) ligand in men with suspected prostate cancer recurrence based on elevated Prostate-specific antigen (PSA) following prior therapy.

Full description

The primary objective of this study was to assess the patient-level correct detection rate (CDR) and region-level positive predictive value (PPV) of rhPSMA-7.3 (18F) positron emission tomography (PET) for biochemical recurrence (BCR) of prostate cancer using histopathology or imaging as a standard of truth (SoT).

Enrollment: 391 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is male and aged >18 years old.

2. History of localized adenocarcinoma of the prostate with prior curative intent treatment.

3. An elevated PSA, clinically suspicious for biochemically recurrent disease:

   • Following Radical Prostatectomy: PSA >0.2 ng/mL
   • Following Radiotherapy: nadir +2 ng/mL.

4. Potentially eligible for salvage therapy with curative intent.

Exclusion criteria

1. Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan.
2. Patients currently receiving Androgen Deprivation Therapy (ADT).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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391 participants in 1 patient group

Patients

Experimental group

Description:

Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan

Treatment:

Diagnostic Test: Positron emission tomography scan

Drug: rhPSMA-7.3 (18F) Injection