NCT06003556RecruitingPhase 2
PSMA-Guided Ablation of the Prostate
PSMA-Guided Ablation of the Prostate: A Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- First submitted
- 7 Aug 2023
- Start date
- 2 Apr 2024
- Primary completion date
- 26 Feb 2029
- Lead sponsor
- University of Alberta
- Diseases
- Prostate cancer
- NCT number
- NCT06003556
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 138
- From 2 Apr 2024 to the primary completion date, 26 Feb 2029
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior androgen deprivation therapy or radiation therapy to prostate gland
Lab values
- eGFR \< 40 mL/min/1.73 m2 and/or a history of a severe reaction to CT contrast
Other
- 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
Who the study is looking for
- Age \> 50
- Clinical stage \< T2b
- PSA \< 15
- Combined targeted and systematic MRI-guided biopsy shows unilateral Gleason Grade Group 2 or 3 prostate cancer
Age in the registry: 50 years to - · Sex: Male · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prostate Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| University of Alberta Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Royal Alexandra Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.