CompletedPhase 3

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

United States391 participantsStarted 2020-05-04

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Patient is male and aged \>18 years old.
✓. History of localized adenocarcinoma of the prostate with prior curative intent treatment.
✓. An elevated PSA, clinically suspicious for biochemically recurrent disease:
✓. Potentially eligible for salvage therapy with curative intent.

Exclusion criteria

✕. 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).

What they're measuring

Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT

Timeframe: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan

Trial details

NCT IDNCT04186845

SponsorBlue Earth Diagnostics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04-28

Results submitted2024-07-19

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