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PSMA-Guided Ablation of the Prostate

Study acronym: P-GAP
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study sites: 3 to 4v12
  2. Site details revised at 1 of 3 sitesv11
  3. Study sites: 2 to 3v10
  4. Re-verified, no change to tracked fieldsv9
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Feb 26, 2024 to Apr 2, 2024v7
  2. Start date: Jan 15, 2024 to Feb 26, 2024
    • Primary and study completion dates: Jan 29, 2029 to Feb 26, 2029
    v6
  3. Secondary endpoints: details revised at 4 of 12 entriesv5
  4. Primary endpoint revisedv4 Show 4 more changesShow less
    • Primary and study completion dates: Sep 29, 2028 to Jan 29, 2029
    • Start date: Dec 30, 2023 to Jan 15, 2024
    • Secondary endpoints: 8 to 12
    • Study description expanded, about 10 words
  5. Start date: Nov 15, 2023 to Dec 30, 2023v3
  6. Start date: Sep 29, 2023 to Nov 15, 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06003556
Lead Sponsor University of Alberta
Conditions
(from sponsor)		 Prostate Cancer, Localized Prostate Carcinoma
Related terms Prostatic Neoplasms
Enrollment 138 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov