Recent guidelines favor transperineal (TP) prostate biopsies over the transrectal (TR) approach due to a reduced sepsis risk. Yet, evidence from controlled trial comparing both approaches within the MRI-targeted pathway for significant prostate cancer (PCa) detection is lacking.
To compare the significant PCa detection rate between magnetic resonance imaging (MRI)-targeted TR and TP approaches in biopsy-naïve patients.
In this noninferiority controlled trial, we randomized (ratio 1:1) 270 MRI-positive biopsy-naïve patients.
MRI-targeted TP versus TR biopsy.
The primary outcome was the detection rate of significant PCa (International Society of Urological Pathology [ISUP] ≥2) in MRI-targeted biopsies. Secondary outcomes were any-grade PCa detection, detection on concomitant systematic biopsy, complications, and functional outcomes.
Targeted biopsies identified significant PCa in 47.2% of TP and 54.2% of TR participants (-7%, p = 0.6235). On a per-lesion analysis, posterior lesions yielded higher detection rates via TR (59.0% vs 44.3%, p = 0.0443), while anterior lesions were more frequently detected via TP (40.6% vs 26.5%, p = 0.2228). The overall (any grade) cancer detection rate in targeted biopsies was comparable between groups: 71.3% (TP) versus 64.1% (TR; p = 0.2209) with significantly more ISUP 1 cases detected in the TP arm. Adverse events of grade ≥2 were not different between TP (35.7%) and TR (40.5%, p = 0.4256). One TR patient (0.8%) experienced grade 3 sepsis. Quality of life, and urinary and sexual function, as well as pain scores, were comparable between groups.
Despite a comparable overall detection rate for any-grade PCa, noninferiority of TP over TR for MRI-targeted biopsies for significant PCa detection was not demonstrated. However, MRI lesion location influenced biopsy route performance, suggesting that a pragmatic approach based on lesion location might enhance significant PCa assessment.
This trial compared the efficacy and safety of two biopsy approaches for prostate cancer diagnosis. Both approaches seem complementary according to the lesion location.
European urology oncology. 2024 Feb 24 [Epub ahead of print]
Guillaume Ploussard, Eric Barret, Gaëlle Fiard, Louis Lenfant, Bernard Malavaud, Gianluca Giannarini, Christophe Almeras, Richard Aziza, Raphaële Renard-Penna, Jean-Luc Descotes, François Rozet, Jean-Baptiste Beauval, Ambroise Salin, Morgan Rouprêt
La Croix du Sud Hospital, Quint-Fonsegrives, France. Electronic address: ., Institut Mutualiste Montsouris, Paris, France., Grenoble Alpes University Hospital, University Grenoble Alpes, CNRS, Grenoble INP, TIMC-IMAG, Grenoble, France., AP-HP - Pitié-Salpêtrière Hospital, Sorbonne University, Paris, France., Comprehensive Cancer Cancer IUCT-Oncopole, Toulouse, France., Santa Maria della Misericordia University Hospital, Udine, Italy., Clinique Capio La Croix du Sud Cabinet d'Urologie, Quint-Fonsegrives, France., CHU Grenoble Alpes, Grenoble, France., Capio La Croix du Sud Clinic, Quint-Fonsegrives, France., La Croix du Sud Hospital, Quint-Fonsegrives, France.