Tests a PSMA PET scan to plan focal treatment for prostate cancer
Tests a PSMA PET scan to check prostate cancer spread before focal treatment.
Plain-language title generated from the registry record
Registry title: PSMA-Guided Ablation of the Prostate
Key facts
- Where
- Calgary, Edmonton, and Toronto, CanadaSee the 4 sites
- Phase
- Phase 2
Where in Canada
- Prostate Cancer CentreCalgary, CanadaTaking people
- Royal Alexandra HospitalEdmonton, CanadaTaking people
- University of Alberta HospitalEdmonton, CanadaTaking people
- Princess Margaret Cancer CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Alberta
- Trial code
- NCT06003556
- Record updated
- 3 June 2026
- Original description
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.Read full original descriptionShow less
PSMA-Guided Ablation of the Prostate: A Multicenter Randomized Controlled Trial
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.
Inclusion: Age > 50; Clinical stage < T2b; PSA < 15; Combined targeted and systematic MRI-guided biopsy shows unilateral Gleason Grade Group 2 or 3 prostate cancer.
Exclusion: Prior androgen deprivation therapy or radiation therapy to prostate gland; eGFR < 40 mL/min/1.73 m2 and/or a history of a severe reaction to CT contrast; Unable to obtain consent; Weight >250 kg (weight limitation of scanners); Unable to lie flat for 30 minutes to complete the PET imaging; Lack of intravenous access.