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Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance

ConditionsProstatic NeoplasmsProstate CancerProstate Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorIcahn School of Medicine at Mount Sinai

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 clinically significant prostate cancer compared to MRI alone. Eligible participants will undergo rhPSMA-7.3 (¹⁸F) PET/CT and mpMRI prior to confirmatory prostate biopsy. Biopsies will target areas identified on MRI, PET/CT, or both, and histopathologic outcomes will serve as the reference standard. The study will assess lesion-level concordance between PET/CT, MRI, and pathology, and evaluate the predictive value of PET/CT for disease upgrading. Approximately 120 participants will be enrolled at Mount Sinai Hospital over 12 months. Study participation will involve one imaging visit, one confirmatory biopsy, and follow-up through review of clinical results. There is minimal risk to participants beyond standard diagnostic procedures. The study is funded jointly by the Icahn School of Medicine at Mount Sinai and Blue Earth Diagnostics, which provides the imaging agent flotufolastat F18 and technical support.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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: Grade Group 2, PSA 10-20 ng/mL, cT2b-c Currently managed with active surveillance.

Able and willing to undergo rhPSMA-7.3 (¹⁸F) PET/CT imaging, mpMRI, and confirmatory prostate biopsy.

Disqualifiers

A history of other active malignancy within the last 5 years, except for non-melanoma skin cancer.

Contraindication to 3-T mpMRI.

Significant intercurrent morbidity** limiting compliance with study protocols.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to Agent(s) or other agents used in study.

Trial design

Design model

Single group

Treatments tested in this trial

  • rhPSMA-7.3 (18F) PET/CT Imaging (Flotufolastat F18, POSLUMA®)

    Radiation

    Participants will undergo a single rhPSMA-7.3 (¹⁸F) PET/CT scan using flotufolastat F18 (POSLUMA®), an FDA-approved PSMA-targeted radiotracer. The radiotracer will be administered intravenously at the standard diagnostic dose prior to PET/CT image acquisition. The scan will be performed according to institutional imaging protocols, approximately 50-70 minutes post-injection.

  • Flotufolastat F18

    Drug

    An FDA-approved PSMA-targeted radiotracer. The radiotracer will be administered intravenously at the standard diagnostic dose prior to PET/CT image acquisition.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: rhPSMA-7.3 (18F) PET/CT ImagingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of participants with Grade Group ≥ 2

Detection rate measured by the proportion of participants with clinically significant prostate cancer (csPCa) (Grade Group ≥2) using rhPSMA-7.3 (¹⁸F) PET/CT compared to standard mpMRI confirmed on targeted or systematic biopsy Clinically significant prostate cancer is defined as Gleason Grade Group ≥ 2 (Gleason score ≥ 3+4 Predominantly well-formed glands with a lesser component of poorly-formed/fused/cribriform glands) based on histopathologic evaluation of biopsy cores obtained after PET/CT imaging.

Time frame
Up to 3 months after PET/CT imaging

Secondary outcomes

1

Incremental detection rate of csPCa by PET/CT over MRI

Proportion of participants in whom PET/CT leads to biopsy-confirmed csPCa (Grade Group ≥2) from a PET-positive / MRI-negative target measured by number of participants with csPCa detected on PET-positive, MRI-negative lesion from all participants who complete both imaging modalities and biopsy.

Time frame
up to 6 months
2

Lesion-level concordance between rhPSMA-7.3 (¹⁸F) PET/CT, multiparametric MRI, and histopathology

Concordance (Yes/No) per lesion for location (lobe/zone/segment) and significance (csPCa yes/no on biopsy).

Time frame
Up to 6 months following enrollment (from baseline imaging to confirmatory biopsy)
3

Predictive value of PET SUVmax for detecting clinically significant disease

Comparing lesion-level concordance between PET/CT, mpMRI, and histopathology. Evaluating the predictive value of PET SUVmax for detecting clinically significant disease.

Time frame
Baseline to 6 months
4

Sensitivity

Sensitivity is defined as the probability of a positive PET/CT who actually have clinically significant disease.

Time frame
Baseline to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Blue Earth Diagnostics

Collaborator

Source ClinicalTrials.gov
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