Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Official Title

A Prospective, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Men With Suspected Prostate Cancer Recurrence Based on Elevated PSA Following Prior Therapy.

Keywords

Prostate Cancer Recurrent Prostate Cancer Diagnostic Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) Scan Prostatic Neoplasms Recurrence rhPSMA-7.3 (18F) Injection

Eligibility

You can join if…

Open to males ages 18 years and up

  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.

You CAN'T join if...

  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).

Locations

  • University of California Irvine Medical Center (UCIMC) accepting new patients
    Orange California 92868 United States
  • Tower Urology accepting new patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Blue Earth Diagnostics
ID
NCT04186845
Phase
Phase 3
Study Type
Interventional
Last Updated