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NCT06003556: P-GAP

PSMA-Guided Ablation of the Prostate

Recruiting now Phase 2 Last updated 4 July 2025
What this trial tests

Phase 2 trial testing PSMA-1007 Positron Emission Tomography (PET) scan in Prostate Cancer in 138 participants. Currently enrolling.

Timeline
2 April 2024
Primary endpoint
26 February 2029
26 February 2029

Quick facts

Lead sponsorUniversity of Alberta
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposediagnostic
Enrollment138
Start date2 April 2024
Primary completion26 February 2029
Estimated completion26 February 2029
Sites3 locations across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of Alberta

Who can join

50 and older, male only, with Prostate Cancer or Localized Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Beyond fluorodeoxyglucose: Molecular imaging of cancer in precision medicine.
    Juweid ME, Al-Qasem SF, Khuri FR, Gallamini A, et al · · 2025 · cited 9× · PMID 40183513 · DOI 10.3322/caac.70007

Verify or expand the search:

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

Other University of Alberta trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06003556.

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