(UroToday.com) The 2025 European Association of Urology (EAU) Annual Meeting held in Madrid, Spain was host to the Abstract Session 05: On the horizon: Ongoing trials in urology. Dr. Patrick Albers presented Abstract A0076: PSMA-Guided Ablation of the Prostate (P-GAP): A Multicenter Randomized- Controlled Trial.
Dr. Albers began his presentation by stating that focal therapy is a treatment option for unilateral localized prostate cancer. However, current diagnostic methods often underestimate cancer laterality and spread, highlighting an unmet need for improved accuracy to enhance focal therapy outcomes. If a lesion goes undiagnosed and untreated, as shown in the figure below, it could lead to treatment failure.
¹⁸F-PSMA-1007 PET/CT is a promising alternative for improving the detection of cancer laterality and spread compared to standard diagnostic methods, such as MRI-guided prostate biopsy, in men planning to undergo focal therapy. As illustrated in the figure below, MRI and ¹⁸F-PSMA-1007 PET/CT may show concordant findings; however, discrepancies between these imaging modalities could lead to cancer underestimation with conventional imaging.
This study aims to compare ¹⁸F-PSMA-1007 PET/CT with standard diagnostic methods in the workup of men undergoing focal therapy. The researchers hypothesize that patients who undergo ¹⁸F-PSMA-1007 PET/CT before focal therapy will have lower rates of clinically significant prostate cancer detected post-treatment.
This was a multicenter, randomized Controlled Trial, planning to enroll 138 men from 3 sites including the University of Alberta, University of Calgary, and University of Toronto. Inclusion Criteria were:
- Age ≥ 50
- Clinical stage ≤ T2b
- PSA ≤ 15 ng/mL
- Combined targeted and systematic MRI-guided biopsy shows unilateral Gleason Grade Group 2 or 3 prostate cancer
Exclusion criteria for this trial were:
- Unable to obtain informed 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
- Intraductal or small cell carcinoma diagnosis
The trial scheme is shown below. Briefly, patients will be randomized 1:1 to either ¹⁸F-PSMA-1007 PET/CT or no additional imaging. Those with unilateral cancer or in the no additional imaging arm will undergo hemigland ablation and receive a ¹⁸F-PSMA-1007 PET/CT and MRI-guided biopsy at 12 months.
The primary and secondary outcomes of the P-GAP randomized controlled trial are described in detail below:
Presented by: Patrick Albers, MD, Urology Resident at University of Alberta, Dept. of Surgery, Division of Urology, Edmonton, Canada.
Written by: Julian Chavarriaga, MD – Urologic Oncologist at Cancer Treatment and Research Center (CTIC) via Society of Urologic Oncology (SUO) Fellow at The University of Toronto. @chavarriagaj on Twitter during the European Association of Urology (EAU) 2025 Annual Meeting, Madrid, Spain, Fri, Mar 21 – Mon, Mar 24, 2025.