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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.


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04186845

Sponsor: Blue Earth Diagnostics

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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).

View trial on ClinicalTrials.gov


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