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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 newly diagnosed prostate cancer

Not Enrolling

Trial ID:NCT04186819

View complete trial on ClinicalTrials.gov

Protocol #:20-073

877-DF-TRIAL (877-338-7425)

Condition(s):Prostate Cancer

Phase:III

Principal Investigator:Preston, Mark

Trial Description:
A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer.

Eligibility Requirements:
1. Patient is male and aged >18 years old.
2. Histologically confirmed adenocarcinoma of the prostate.
3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).
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, or with a prior history of, Androgen Deprivation Therapy (ADT).

Protocol #: 20-073

Questions & Enrollment
877-DF-TRIAL
(877-338-7425)