German S3 Evidence-Based Guidelines on Focal Therapy in Localized Prostate Cancer: The First Evidence-Based Guidelines on Focal Therapy

Abstract

<b><i>Background:</i></b> Focal therapy (FT) is an option to treat localized prostate cancer (PCa) and preserve healthy prostate tissue in order to reduce known side effects from primary whole-gland treatment. The available FT modalities are manifold. Until now, national and international PCa guidelines have been cautious to propose recommendations regarding FT treatment since data from prospective controlled trials are lacking for most FT modalities. Moreover, none of the international guidelines provides a separate section on FT. In this purpose, we provide a synopsis of the consensus-based German S3 guidelines for a possible international use. <b><i>Summary:</i></b> The recently published update of the German S3 guidelines, an evidence- and consensus-based guideline, provides a section on FT with recommendations for diagnostic work-up, indications, modalities, and follow-up. This section consists of 12 statements and recommendations for FT in the treatment of localized PCa. <b><i>Key Message:</i></b> The German S3 guidelines on PCa are the first to incorporate recommendations for FT based on evidence and expert consensus including indication criteria for FT, pretreatment, and follow-up diagnostic pathways as well as an extended overview of FT techniques and the current supportive evidence.

Medium-term oncological outcomes of intermediate-risk prostate cancer treated with HIFU or cryotherapy. A single center 10-year experience

“…With FT on the rise in both recognition and availability (17,18), our current and other's reports (19) show that clinicians have been treating patients with higher risks both on and off trial, as some patients express a desire to undergo FT outside of those criteria, searching for a chance of benefit (avoiding or delaying complications) when treatment is advised but there is no immediate threat to life, as is the case of localized intermediate-risk PCa. While urological guidelines (1,6) still consider FT as experimental treatments, the German Society of Urology (20) has published in 2022 a list of recommendations considering FT an option for patients with unilateral low-risk PCa who decline "standard therapies" and active surveillance, but reminding of the available data being insufficient to access FT oncological effectiveness. Other publication has reported on a Delphi-method consensus meetings of 47 FT experts recommending allowing treatment of low and intermediate-risk PCa with volume up to 3 mL in 1 hemi-gland, if total PSA lower than 10 ng/mL (21).…”

“…The median age was 69 (IQR 62-72) years, with 114 (76%) patients having no palpable disease on digital rectal examination. Median total PSA was of 7.85 (IQR 5.75-10.62) ng/mL, with 46 (31%) of patients having an initial total PSA between 10-20 ng/mL and none higher than 20 When analyzing biopsy results by region among the 126 (84%) patients with suspicious lesions on MRI: 93 (74%) had csPCa -46 (37%) had csPCa only on suspicious lesions; 31 (25%) had csPCa on suspicious lesions and lesion-adjacent systematic biopsy cores; 8 (6%) had csPCa only on lesion-adjacent systematic biopsy cores; 4 (3%) had csPCa only on non-lesion-adjacent systematic biopsy cores; 3 (2%) had csPCa on suspicious lesions, lesion-adjacent and non-lesion-adjacent systematic biopsy cores; 1 (1%) had csPCa on lesion-adjacent and nonlesion-adjacent systematic biopsy cores but not on suspicious lesions; 0 (0%) had csPCa on suspicious lesions and non-lesion-adjacent systematic biopsy cores.…”

Guidelines of guidelines: focal therapy for prostate cancer, is it time for consensus?

“…If no mpMRI is available, Donaldson et al [14] and Tan et al [11] agreed that transperineal three-dimensional (3D) mapping biopsies are sufficient, whereas Tay et al [10] agreed that systematic TRUS biopsies are sufficient. Borkowetz et al [9] recommended a template-based biopsy if mpMRI was not available.…”

“…Borkowetz et al. [ 9 ] formed the German S3 guidelines for FT in localised PCa. Their recommendations were based on either their literature search or consensus from 18 FT experts (urologists, radio‐oncologists, radiologists, and pathologists).…”

“…Selection is usually based on patient and disease characteristics obtained after thorough screening and is used for informed decision making and FT planning. Below we summarise consensus statements published from 2015–2022, the evolution over time, which is also depicted in Table 3 [ 9 , 10 , 11 , 12 , 13 , 14 ].…”