NCT06003556|RecruitingPhase 2DMC
PSMA-Guided Ablation of the Prostate
P-GAP
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Sponsor study identifier
interventional
138
1 country
4
Study Start
April 2, 2024
Actual (reported)Primary Completion
February 26, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 26, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 26, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 7, 2023
Actual (reported)August 22, 2023
Actual (reported)April 2, 2024
Actual (reported)February 26, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 26, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Tumor Staging- Detection of any clinically significant prostate cancer
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
12 months after hemigland ablation.
Tumor Staging - bilateral disease on PSMA PET prior to hemi-gland ablation
Prior to hemigland ablation - at study enrollment
Tumor Staging - bilateral disease on PSMA PET after hemi-gland ablation
12 months after hemigland ablation.
Tumor Staging- rate of contralateral Gleason Grade Group 2 or greater prostate cancer at biopsy
12 months after hemigland ablation.
Tumor Staging - rate of contralateral Gleason Grade Group 2 or greater prostate cancer at final pathology
Through study completion, expected within 1 year of randomization
Tumor Staging - 5-year failure free survival
5 years after hemigland ablation
These patients will have been diagnosed with unilateral prostate cancer by standard of care diagnostic tests deemed eligible and interested in focal therapy. These patients will be randomized to undergo a single \[18\]F-PSMA-1007 PET/CT or PET/MRI scan prior to focal therapy. If they are diagnosed with bilateral disease, they will be ineligible for focal therapy and be referred for radical therapy. Those with unilateral disease will then proceed to focal therapy. They will then receive PSMA PET, MRI, and combined targeted and systematic biopsy 12 months after ablation Intravenous bolus injection of 4 MBq/kg +/- 10% of \[18\]F-PSMA-1007, up to a maximum of 400 MBq.
These patients will have been diagnosed with unilateral prostate cancer by standard of care diagnostic tests deemed eligible and interested in focal therapy. These patients will undergo no further testing and will undergo focal therapy. They will then receive PSMA PET, MRI, and combined targeted and systematic biopsy 12 months after ablation. Intravenous bolus injection of 4 MBq/kg +/- 10% of \[18\]F-PSMA-1007, up to a maximum of 400 MBq.
Additional staging PET scan prior to focal therapy to focal therapy.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Prostate Cancer Centre
Calgary, Alberta, T2V 1P9, Canada
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
First Submitted
August 7, 2023
First Posted
August 22, 2023
Study Start
April 2, 2024
Actual (reported)Primary Completion
February 26, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Study Completion
February 26, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 3, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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