Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

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:
  4. Following Radical Prostatectomy: PSA >0.2 ng/mL
  5. Following Radiotherapy: nadir +2 ng/mL.
  6. 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).

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Positron Emission Tomography (PET) Imaging study
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Patients
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
  • Drug: rhPSMA-7.3 (18F) Injection
    Radioligand for PET CT scanning

Recruiting Locations

Montefiore Hospital
Bronx, New York 10461
Contact:
Benjamin Gartrell

More Details

Status
Recruiting
Sponsor
Blue Earth Diagnostics

Study Contact

Jingke Yang, MD
+1 978 313 3834
Jingke.Yang@parexel.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.