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
- Age: minimum 18 Years maximum N/A
- Gender: Male
- 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.
- Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan.
- Patients currently receiving Androgen Deprivation Therapy (ADT).
View trial on ClinicalTrials.gov