Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance
Recruiting
Phase 2
Interventional Study
Prostatic Neoplasms
Prostate Cancer
Prostate Adenocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 120 (estimated)
- Sponsor
- Icahn School of Medicine at Mount Sinai · Other
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About This Trial
This investigator-initiated, prospective study evaluates the diagnostic utility of rhPSMA-7.3 (¹⁸F) PET/CT (flotufolastat F18, marketed as POSLUMA®) in men with biopsy-proven, low-risk or favorable intermediate-risk prostate cancer managed with active surveillance. The study aims to determine whether the addition of PSMA-based PET/CT to standard multiparametric MRI (mpMRI) improves detection of cl…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Male participants aged ≥18 years.
* Histologically confirmed diagnosis of prostate adenocarcinoma.
* Classified as low-risk or favorable intermediate-risk prostate cancer according to NCCN criteria: Low-risk: Grade Group 1, PSA \<10 ng/mL, cT1-T2a Favorable intermediate-risk: …
Contacts