PSMA-Guided Ablation of the Prostate
P-GAP
1 other identifier
interventional
138
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Apr 2024
Typical duration for phase_2 prostate-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2023
CompletedFirst Posted
Study publicly available on registry
August 22, 2023
CompletedStudy Start
First participant enrolled
April 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 26, 2029
July 4, 2025
July 1, 2025
4.9 years
August 7, 2023
July 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
PSMA PET
EXPERIMENTALThese 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.
No Additional Imaging
NO INTERVENTIONThese 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.
Interventions
Additional staging PET scan prior to focal therapy to focal therapy.
Eligibility Criteria
You may qualify if:
- Age \> 50
- Clinical stage \< T2b
- PSA \< 15
- Combined targeted and systematic MRI-guided biopsy shows unilateral Gleason Grade Group 2 or 3 prostate cancer
You may not qualify if:
- 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
- eGFR \< 40 mL/min/1.73 m2 and/or a history of a severe reaction to CT contrast
- Prior androgen deprivation therapy or radiation therapy to prostate gland
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Prostate Cancer Centre
Calgary, Alberta, T2V 1P9, Canada
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2023
First Posted
August 22, 2023
Study Start
April 2, 2024
Primary Completion (Estimated)
February 26, 2029
Study Completion (Estimated)
February 26, 2029
Last Updated
July 4, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share