PSMA-Guided Ablation of the Prostate

Condition(s) studied

Investigational drug(s) / intervention(s)

PSMA-1007 Positron Emission Tomography (PET) scan: Additional staging PET scan prior to focal therapy to focal therapy.

Study summary

The goal of this phase 2 multicenter randomized controlled trial is to study the accuracy of second generation prostate specific membrane antigen (PSMA) positron emission tomography (PET; utilizing 18F-PSMA-1007) compared to standard of care multiparametric MRI and MRI targeted-prostate biopsy for staging in patients diagnosed with unilateral prostate cancer who are eligible for focal therapy.

The main question it aims to answer is:

Can PSMA PET improve diagnostic accuracy for the primary staging of Prostate Cancer for patients undergoing focal therapy thereby reducing residual and recurrence disease?

Participants who are eligible by current standard of care diagnostic workup will undergo 1:1 randomization to PSMA PET scan or no further imaging. Those diagnosed with bilateral disease by PSMA PET will be ineligible for focal therapy and be referred for radical therapy. Men with unilateral disease on PSMA PET and those randomized to no further imaging will then undergo focal therapy. All men undergoing focal therapy will receive PSMA PET, MRI, and combined targeted and systematic biopsy 12 months after ablation. The primary outcome will be the detection of Gleason Grade Group 2 or higher prostate cancer in men 12 months after hemigland ablation.

Eligibility

Primary outcome measure(s)

• Tumor Staging- Detection of any clinically significant prostate cancer — 12 months after hemigland ablation.
  Detection of any clinically significant prostate cancer (defined as greater than or equal to Gleason Grade Group 2) at MRI-guided combined targeted and systematic biopsy

Trial sites (4)

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