PSMA-Guided Ablation of the Prostate
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 d
| Condition(s) | Prostate Cancer, Localized Prostate Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 PS |
| Who can participate | Inclusion Criteria: 1. Age \> 50 2. Clinical stage \< T2b 3. PSA \< 15 4. Combined targeted and systematic MRI-guided biopsy shows unilateral Gleason Grade Group 2 or 3 prostate cancer Exclusion Criteria: 1. Unable to obtain consent 2. Weight \>250 kg (weight limitation of scanners) 3. Unable to lie flat for 30 minutes to complete the PET imaging 4. Lack of intravenous access 5. eGFR \< 40 mL/min/1.73 m2 and/or a history of a severe reaction to CT contrast 6. Prior androgen deprivation therapy or radiation therapy to prostate gland |
| Ages | 50 Years |
| Sex | Male |
| Lead sponsor | University of Alberta |
| Locations | Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Edmonton, Alberta, Canada; Toronto, Ontario, Canada |
| Start date | 2024-04-02 |
| NCT ID | NCT06003556 |
| Official listing | https://clinicaltrials.gov/study/NCT06003556 |