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    Appendix

    The following table outlines the studies that are considered potentially relevant to the IP overview but were not included in the summary of the key evidence. It is by no means an exhaustive list of potentially relevant studies. Studies with fewer than 50 people were excluded from this appendix.

    Additional papers identified

    Article

    Number of people/ follow up

    Direction of conclusions

    Reasons for non-inclusion in summary of key evidence section

    Abreu AL, Peretsman S, Iwata A et al. (2020) High Intensity Focused Ultrasound Hemigland Ablation for Prostate Cancer: Initial Outcomes of a United States Series. The Journal of urology 204(4):741-7

    Case series

    n=100

    FU=20 months

    Short-term results of focal high intensity focused ultrasound indicate safety, excellent potency and continence preservation, and adequate short-term prostate cancer control. Radical treatment was avoided in 91% of men at 2 years. Men with bilateral prostate cancer at diagnosis have increased risk for Grade Group 2 or greater recurrence.

    Studies with more people or longer follow up included. Included in the Bakavicius, 2022 systematic review.

    Abufaraj M, Siyam, A, Ali M et al. (2021) Functional outcomes after local salvage therapies for radiation-recurrent prostate cancer patients: a systematic review. Cancers 13(2):244.

    Systematic review

    n=2 studies using focal HIFU

    Local salvage therapies for radiation recurrent prostate cancer affect continence, lower urinary tract symptoms and sexual functions. The use of local salvage therapies may be warranted in the setting of local disease control, but each individual decision must be made with the informed patient in a shared decision working process.

    Most studies included did not use focal HIFU.

    Ahmed HU, Dickinson L, Charman S et al. (2015) Focal ablation targeted to the index lesion in multifocal localised prostate cancer: a prospective development study. European urology 68(6):927-936.

    Prospective case series

    n=56

    FU=12 months

    Index lesion ablation had low rates of genitourinary side effects and acceptable short-term absence of clinically significant cancer. Comparative effectiveness trials are required to assess cancer control outcomes against radical therapy.

    Studies with more people or longer follow up included. Included in the Bakavicius, 2022 systematic review.

    Albisinni S, Melot C, Aoun F et al. (2018) Focal Treatment for Unilateral Prostate Cancer Using High-Intensity Focal Ultrasound: A Comprehensive Study of Pooled Data. Journal of endourology 32(9):797-804

    Pooled analysis

    n=366

    FU=26 months

    This pooled analysis of the results of focal HIFU treatment of prostate cancer shows promising oncologic and functional outcomes. Well-selected people may be candidates for such a conservative partial treatment of the gland. Well-designed trials are awaited to compare HIFU focal treatment with current standard of care

    More recent systematic reviews included.

    Albisinni S, Aoun F, Bellucci S et al. (2017) Comparing High-Intensity Focal Ultrasound Hemiablation to Robotic Radical Prostatectomy in the Management of Unilateral Prostate Cancer: A Matched-Pair Analysis. Journal of endourology 31(1):14-9

    Matched-pair analysis

    n=55

    FU=36 months

    HIFU hemiablation was comparable to robot-assisted laparoscopic prostatectomy in controlling localised unilateral prostate cancer, with no significant differences in the need for salvage therapies. HIFU was also associated to significantly better functional outcomes.

    Larger matched- pair analysis included. Included in the Bakavicius, 2022 systematic review.

    Annoot A, Olivier J, Valtille P et al. (2019) Extra-target low-risk prostate cancer: implications for focal high-intensity focused ultrasound of clinically significant prostate cancer. World journal of urology 37(2):261-8

    Retrospective cohort

    n=55

    FU=33 months

    Presence or not of an extra-target non-clinically significant cancer in the untreated part of the gland had no impact on radical treatment free survival. Radical treatment free survival was 80% at 3 years which support the concept of focal/partial treatment as a treatment option of prostate cancer.

    Studies with more people or longer follow up included. Included in the Bakavicius, 2022 systematic review.

    Aoun F, Limani K, Peltier A et al. (2015) High Intensity Focused Ultrasound versus Brachytherapy for the Treatment of Localized Prostate Cancer: A Matched-Pair Analysis. Advances in urology 2015:350324

    Matched-pair analysis

    n=70

    FU=83 months

    HIFU and brachytherapy are safe with no significant difference in cancer specific survival on long term oncologic follow-up. Nonetheless, a randomised controlled trial is needed to confirm these results

    Larger matched- pair analysis included.

    Avila M, Patel L, Lopez S et al. (2018) Patient-reported outcomes after treatment for clinically localized prostate cancer: A systematic review and meta-analysis. Cancer treatment reviews 66:23-44

    Systematic review and meta-analysis

    No remarkable differences in patient-reported outcomes appeared between modalities within each treatment. Nowadays, available evidence supports brachytherapy as possible alternative to radical prostatectomy for people seeking an attempted curative treatment limiting the risk for urinary incontinence and sexual dysfunction.

    Not all included HIFU studies used focal HIFU.

    Bacchetta F, Martins M, Regusci S et al. (2020) The utility of intraoperative contrast-enhanced ultrasound in detecting residual disease after focal HIFU for localized prostate cancer. Urologic Oncology: Seminars and Original Investigations 38 (11):846

    Registry analysis

    n=66

    FU=14 months

    Contrast-enhanced ultrasound has a higher added value compared to early mpMRI in ruling out clinically significant cancer after focal HIFU. It should be evaluated whether the use of Contrast-enhanced ultrasound intraoperatively enhances the efficacy of focal HIFU.

    Studies with more people or longer follow up included.

    Bakavicius A, Sanchez-Salas R, Muttin F et al. (2019) Comprehensive Evaluation of Focal Therapy Complications in Prostate Cancer: A Standardized Methodology. Journal of endourology 33(7): 509-15

    Case series

    n=336

    FU=11 months

    Focal HIFU and focal cryosurgical ablation of the prostate provide a tolerable toxicity, with primarily minor complications presenting in the early postoperative period.

    Studies with more people or longer follow up included.

    Bass R, Fleshner N, Finelli A et al. (2019) Oncologic and Functional Outcomes of Partial Gland Ablation with High Intensity Focused Ultrasound for Localized Prostate Cancer. The Journal of urology 201(1): 113-9

    Case series

    n=150

    FU=24.3 months

    Partial gland ablation with high intensity focused ultrasound therapy was safe and it had a minimal impact on functional outcomes. Local recurrence and/or failure occurred in 42% of people at high risk for recurrence. Medially located tumours were associated with a higher failure rate. Serious complications were rare. Whole gland treatment was avoided in 81% of people.

    Studies with more people or longer follow up included. Included in the Bakavicius, 2022 systematic review.

    Bates AS, Ayers J, Kostakopoulos N et al. (2021) A Systematic Review of Focal Ablative Therapy for Clinically Localised Prostate Cancer in Comparison with Standard Management Options: Limitations of the Available Evidence and Recommendations for Clinical Practice and Further Research. European urology oncology 4(3):405-23

    Systematic review

    n=1 study

    The certainty of the evidence regarding the comparative effectiveness of focal therapy as a primary treatment for localised prostate cancer was low, with significant uncertainties. Until higher certainty evidence emerges from robust prospective comparative studies measuring clinically meaningful outcomes at long-term time points, focal therapy should ideally be performed within clinical trials or well-designed prospective cohort studies.

    More recent systematic reviews included.

    Baydoun A, Traughber B, Morris N et al. (2017) Outcomes and toxicities in patients treated with definitive focal therapy for primary prostate cancer: Systematic review. Future Oncology 13(7):649-63

    Systematic review

    n=2 studies

    Focal therapy has fewer adverse side effects and is more easily tolerated than conventional, whole-gland prostate cancer treatments.

    More recent systematic reviews included.

    Borges RC, Tourinho-Barbosa, RR, Glina S et al. (2021) Impact of Focal Versus Whole Gland Ablation for Prostate Cancer on Sexual Function and Urinary Continence. The Journal of urology 205(1):129-36

    Cohort study

    n=117

    FU=55 months

    Focal ablation instead of whole gland therapy is the most important factor related to better sexual and urinary continence recovery after high intensity focused ultrasound and cryotherapy for prostate cancer.

    Comparative studies with more people or longer follow up included. High proportion of people treated with cryotherapy in focal therapy group.

    Claros OR, Tourinho-Barbosa RR, Carneiro A et al. (2019) HIFU focal therapy for prostate cancer using intraoperatory contrast enhanced ultrasound. Archivos espanoles de urologia 72(8):825-30

    Case series

    n=59

    FU=18 months

    Our study shows that the use of Sonovue after HIFU focal therapy was safe. People present a significant proportion of failure after HIFU focal therapy but with good functional outcomes and without incidence of severe complications

    Studies with more people or longer follow up included.

    Dellabella M, Branchi A, Di Rosa M et al. (2021) Oncological and functional outcome after partial prostate HIFU ablation with Focal-One R: a prospective single-center study. Prostate cancer and prostatic diseases 24 (4):1189-97

    Case series

    n=189

    FU=29 months

    Index lesion HIFU ablation demonstrated satisfactory early oncological outcome but anteriorly located tumours had inadequate ablation. Urinary function was well preserved. Sexual function slightly decreased during follow-up.

    Studies with more people or longer follow up included.

    Dickinson L, Ahmed HU, Hindley RG et al. (2017) Prostate-specific antigen vs. magnetic resonance imaging parameters for assessing oncological outcomes after high intensity-focused ultrasound focal therapy for localized prostate cancer. Urologic oncology 35(1):30e9-30e15

    Case series

    n=118

    FU=716 days

    Early and late MRI performed better than PSA measurements in the detection of residual tumour after focal therapy

    Studies with more people or longer follow up included. Included in the Bakavicius, 2022 systematic review.

    Donis Canet F, Sanchez Gallego, MD, Arias Funez F et al. (2017) Cryotherapy versus high-intensity focused ultrasound for treating prostate cancer: Oncological and functional results. Actas urologicas espanolas

    Systematic review

    Both techniques have comparable functional results, although the somewhat poorer oncological results for HIFU reflect a steeper learning curve, which could lead to its use in centres with high volumes of people.

    More recent systematic reviews included.

    Fainberg JS, Al Awamlh BAH, DeRosa AP et al. (2021) A systematic review of outcomes after thermal and nonthermal partial prostate ablation. Prostate International 9(4):169-75

    Systematic review

    n=4 studies

    Although oncologic outcomes vary between treatment modalities, systematic review of existing data demonstrates that partial gland ablation is a safe treatment option for people with localised prostate cancer.

    More comprehensive systematic reviews included.

    Fallara G, Capogrosso P, Maggio P et al. (2020) Erectile function after focal therapy for localized prostate cancer: a systematic review. International Journal of Impotence Research

    Systematic review

    n=8 studies

    Overall, reported sexual function outcomes after these treatment modalities were generally good, with many studies reporting a complete recovery of erectile function at 1-year follow-up. However, the quality of current evidence is affected both by the lack of well-conducted comparative studies and by a significant heterogeneity in terms of study design, study population, erectile and sexual function assessment modalities.

    More recent systematic reviews included.

    Faure Walker NA, Norris JM, Shah TT et al. (2018) A comparison of time taken to return to baseline erectile function following focal and whole gland ablative therapies for localized prostate cancer: A systematic review. Urologic oncology 36(2):67-76

    Systematic review

    n=3 studies

    Most studies assessing the outcomes of focal therapy on sexual function were not of high quality, used heterogenous outcomes, and had relatively short follow up, highlighting the need for more robustly designed studies using validated patient reported outcome measures for comparison. However, focal therapy in general resulted in less effect on erectile function than whole gland ablation.

    More recent systematic reviews included.

    Feijoo ERC, Sivaraman A, Barret E et al. (2016) Focal High-intensity Focused Ultrasound Targeted Hemiablation for Unilateral Prostate Cancer: A Prospective Evaluation of Oncologic and Functional Outcomes. European urology 69(2):214-20

    Before-and-after study

    n=71

    FU=12 months

    Focal HIFU hemiablation appears to achieve acceptable oncologic outcomes with low morbidity and minimal functional changes. Longer follow-up will establish future considerations.

    Studies with more people or longer follow up included. Included in the Bakavicius, 2022 systematic review.

    Ganzer R, Hadaschik B, Pahernik S et al. (2018) Prospective Multicenter Phase II Study on Focal Therapy (Hemiablation) of the Prostate with High Intensity Focused Ultrasound. The Journal of urology 199(4):983-9

    Before-and-after study

    n=54

    FU=17.4 months

    Focal therapy hemiablation is safe with little alteration of functional outcome. The oncologic outcome is acceptable on short-term follow-up.

    Studies with more people or longer follow up included. Included in the Bakavicius, 2022 systematic review.

    Garcia-Barreras S, Sanchez-Salas R, Sivaraman A et al. (2018) Comparative Analysis of Partial Gland Ablation and Radical Prostatectomy to Treat Low and Intermediate Risk Prostate Cancer: Oncologic and Functional Outcomes. The Journal of urology 199(1):140-6

    Propensity score matching analysis

    n=188

    FU=38.44 months

    In select people with organ confined prostate cancer partial gland ablation offered good oncologic control with fewer adverse effects that required additional treatments. Potency and continence appeared to be better preserved after partial gland ablation.

    Larger propensity score analysis included (van Son, 2021).

    Golan R, Bernstein AN, McClure TD et al. (2017) Partial Gland Treatment of Prostate Cancer Using High-Intensity Focused Ultrasound in the Primary and Salvage Settings: A Systematic Review. The Journal of urology 198(5):1000-9

    Systematic review

    n=13 studies

    Early evidence suggests that partial gland ablation is a safe treatment option for men with localized disease. Longer term data are needed to evaluate oncologic efficacy and functional outcomes, and will aid in identifying the optimal candidates for therapy

    More recent systematic reviews included.

    Guillaumier S, Peters M, Arya M et al. (2018) A Multicentre Study of 5-year Outcomes Following Focal Therapy in Treating Clinically Significant Nonmetastatic Prostate Cancer. European Urology 74 (4):422-9

    Registry analysis

    n=625

    FU=56 months

    Focal therapy for select people with clinically significant nonmetastatic prostate cancer is effective in the medium term and has a low probability of side effects.

    Cohort captured in Reddy, 2022.

    Guo R-Q, Guo X-X, Li Y-M et al. (2021) Cryoablation, high-intensity focused ultrasound, irreversible electroporation, and vascular-targeted photodynamic therapy for prostate cancer: a systemic review and meta-analysis. International Journal of Clinical Oncology.

    Systemic review and meta-analysis

    n=11

    This meta-analysis shows that cryoablation, HIFU, irreversible electroporation, and vascular-targeted photodynamic therapy are promising therapies for prostate cancer people with similar clinical outcomes. However, further larger, well-designed randomised controlled trials are required to confirm this assertion.

    Mix of focal and whole-gland HIFU studies.

    Hamdy FC, Elliott D, le Conte S et al. (2018) Partial ablation versus radical prostatectomy in intermediate-risk prostate cancer: the PART feasibility RCT. Health technology assessment (Winchester, England) 22(52):1-96

    Feasibility RCT

    n=80

    Randomisation of men to a RCT comparing partial ablation with radical treatments of the prostate is feasible. A full RCT comparing clinical effectiveness, cost-effectiveness and quality-of-life outcomes between radical treatments and partial ablation is now warranted

    Feasibility study.

    Hanada I, Shoji S, Takeda K et al. (2021) Significant Impact of the Anterior Transition Zone Portion Treatment on Urinary Function After Focal Therapy with High-Intensity Focused Ultrasound for Prostate Cancer. Journal of endourology 35(7):951-60

    Before-and-after study

    n=90

    There was a greater risk of urinary dysfunction with treatment in the anterior transition zone portion than in the other portion at 1 month after focal therapy with HIFU.

    Studies with more people or longer follow up included.

    Hong SK and Lee H. (2022) Outcomes of partial gland ablation using high intensity focused ultrasound for prostate cancer. Urologic Oncology: Seminars and Original Investigations.

    Case series

    n=163

    FU=17 months

    Partial gland ablation with HIFU was safe and showed good preservation of functional outcomes as well as satisfactory oncological control. The remnant disease was observed in the 24.5% of people who underwent follow-up biopsy in the present study. Thus, further prospective study is needed to evaluate oncological and functional outcomes of partial gland ablation with HIFU more accurately

    Studies with more people or longer follow up included.

    Hopstaken JS, Bomers JGR, Sedelaar MJP et al. (2022) An Updated Systematic Review on Focal Therapy in Localized Prostate Cancer: What Has Changed over the Past 5 Years? European Urology 81(1):5-33

    Systematic review

    n=27 studies

    Over the past 5 yr, focal therapy has been studied for eight different energy sources, mostly in single-arm stage 2 studies. Although a first randomized controlled trial in focal therapy has been performed, more high-quality evaluations are needed, preferably via multicenter randomized controlled trials with long-term follow-up and predefined assessment of oncological and functional outcomes and health-related quality-of-life measures.

    Shorter time range of included studies (5 years) than Bakavicius, 2022.

    Huber PM, Afzal N, Arya M et al. (2020) An Exploratory Study of Dose Escalation vs Standard Focal High-Intensity Focused Ultrasound for Treating Nonmetastatic Prostate Cancer. Journal of Endourology 34(6):641-6

    Matched pair analysis

    n=162

    This exploratory study shows that dose escalation focal HIFU may achieve higher rates of disease control compared with standard focal HIFU. Further prospective comparative studies are needed.

    Larger matched analysis included (van Son, 2021)

    Huber PM, Afzal N, Arya M et al. (2020) PSA Criteria to Diagnose Failure of Cancer Control following Focal Therapy for Non-metastatic Prostate Cancer Using High Intensity Focused Ultrasound. The Journal of urology.

    Retrospective analysis

    n=598

    Following focal HIFU, nadir+1.0ng/ml at 12 months and nadir+1.5ng/ml at 24 to 36 months might be used to triage those men requiring MRI and biopsy. These need prospective validation.

    Studies with more people or longer follow up included. Included in the Bakavicius, 2022 systematic review.

    Huber PM, Afzal N, Arya M et al. (2020) Focal HIFU therapy for anterior compared to posterior prostate cancer lesions. World journal of urology

    Case series

    n=598

    Treating anterior prostate cancer lesions with focal HIFU may be less effective compared to posterior tumours.

    Studies with more people or longer follow up included.

    Ingrosso G, Becherini C, Lancia A et al. (2020) Nonsurgical Salvage Local Therapies for Radiorecurrent Prostate Cancer: A Systematic Review and Meta-analysis. European urology oncology 3(2):183-97

    Systematic review and meta-analysis

    Nonsurgical therapeutic options, especially brachytherapy, showed good outcomes in terms of biochemical control and tolerability in the local recurrence setting.

    Mixture of focal and whole-gland HIFU studies included.

    Johnston MJ, Emara A, Noureldin M et al. (2019) Focal High-intensity Focussed Ultrasound Partial Gland Ablation for the Treatment of Localised Prostate Cancer: A Report of Medium-term Outcomes From a Single-center in the United Kingdom. Urology 133:175-81

    Case series

    n=107

    FU=30 months

    In a carefully chosen cohort of people for focal HIFU our results suggest acceptable oncological control with minimal postoperative morbidity. Further studies are required to establish this technique as a less morbid alternative to radical therapy.

    Studies with more people or longer follow up included. Included in the Bakavicius, 2022 systematic review.

    Kanthabalan A, Peters M, Van Vulpen M et al. (2017) Focal salvage high-intensity focused ultrasound in radiorecurrent prostate cancer. BJU international 120(2):246-56

    Case series

    n=150

    35 months

    Focal salvage HIFU conferred a relatively low complication and side effect rate. Composite endpoint-free survival and biochemical control in the short to medium term were reasonable, especially in this relatively high-risk cohort, but still low compared with current whole-gland salvage therapies. Focal salvage therapy may offer disease control in men at high risk whilst minimising additional treatment morbidities

    Included in the Koo, 2020 systematic review.

    Kayano PP and Klotz L. (2021) Current evidence for focal therapy and partial gland ablation for organ-confined prostate cancer: systematic review of literature published in the last 2 years. Current opinion in urology 31(1):49-57

    Systematic review

    n=12 studies

    Focal therapy and partial gland ablation for organ-confined prostate cancer is an option for people with intermediate-risk disease because of its low complication profile and preservation of QoL.

    More comprehensive systematic reviews included.

    Linares-Espinos E, Carneiro A, Martinez-Salamanca JI et al. (2018) New technologies and techniques for prostate cancer focal therapy. Minerva urologica e nefrologica = The Italian journal of urology and nephrology 70(3):252-63

    Systematic review

    n=9 studies

    Reliable evidence for the partial-gland treatment of prostate cancer is increasing, and encouraging mid-term oncologic outcomes with the preservation of sexual and urinary functions have been reported. Accurate patient selection at the outset of treatment and careful follow up seem key attributes to achieve excellent functional results and encouraging oncological outcomes.

    More recent systematic reviews included.

    Maestroni U, Tafuri A, Dinale F et al. (2021) Oncologic outcome of salvage high-intensity focused ultrasound (HIFU) in radiorecurrent prostate cancer. A systematic review. Acta bio-medica: Atenei Parmensis 92(4):e2021191

    Systematic review

    n=2 studies

    Our review of the literature revealed that salvage HIFU is effective in the treatment of radiorecurrent clinically localised prostate cancer, with an overall survival of 85.2% at 5 years.

    More comprehensive systematic review on salvage HIFU focal therapy included.

    Mantica G, Chierigo F, Suardi N et al. (2020) Minimally invasive strategies for the treatment of prostate cancer recurrence after radiation therapy: a systematic review. Minerva Urologica e Nefrologica 72(5):586-94

    Systematic review

    Minimally invasive therapeutic options offer promising results in terms of biochemical control in the local recurrence setting. Unfortunately, the absence of high quality and comparative studies makes it difficult to establish which method is the best in terms of oncological and safety outcomes.

    More comprehensive systematic review on salvage HIFU focal therapy included.

    Mortezavi A, Krauter J, Gu A et al. (2019) Extensive Histological Sampling following Focal Therapy of Clinically Significant Prostate Cancer with High Intensity Focused Ultrasound. The Journal of urology 202(4):717-24

    Case series

    n=75

    Focal therapy with high intensity focused ultrasound leads to a low rate of genitourinary side effects. Follow-up biopsy of treated and untreated prostates remains the only modality to adequately select men in need of early salvage treatment.

    Studies with more people or longer follow up included.

    Nahar B, Bhat A, Reis IM et al. (2020) Prospective Evaluation of Focal High Intensity Focused Ultrasound for Localized Prostate Cancer. The Journal of urology 204(3):483-9

    Case series

    n=52

    FU=12 months

    Focal high intensity focused ultrasound is a safe and effective treatment for people with localised clinically significant prostate cancer with acceptable short-term oncologic and functional outcomes. The complications are minimal and patient selection is essential.

    Studies with more people or longer follow up included.

    Perez-Reggeti JI, Sanchez-Salas R, Sivaraman A et al. (2016) High intensity focused ultrasound with Focal-One R device: Prostate-specific antigen impact and morbidity evaluation during the initial experience. Actas urologicas espanolas 40(10):608-14

    Case series

    n=64

    FU=3 months

    Focal-One R HIFU treatment appears to be a safe procedure with few complications. Functional outcomes proved no urinary incontinence and sexual function were maintained in 83%.

    Studies with more people or longer follow up included.

    Ramsay CR, Adewuyi TE, Gray J et al. (2015) Ablative therapy for people with localised prostate cancer: a systematic review and economic evaluation. Health technology assessment (Winchester, England) 19(49):1-490

    Systematic review

    n=4 studies

    Descriptive subgroup assessment within studies reporting the use of focal ablation was limited, but suggested that cancer-specific outcomes were at least comparable with those seen in full-gland therapy studies.

    Small number of focal HIFU studies identified.

    Rischmann P, Gelet A, Riche B et al. (2017) Focal High Intensity Focused Ultrasound of Unilateral Localized Prostate Cancer: A Prospective Multicentric Hemiablation Study of 111 Patients. European urology 71(2):267-73

    Case series

    n=111

    FU=1 year

    At 1 year, HIFU-hemiablation was efficient with 95% absence of clinically significant cancer associated with low morbidity and preservation of quality of life. Radical treatment-free survival rate was 89% at 2 years.

    Studies with more people or longer follow up included. Included in the Bakavicius, 2022 systematic review.

    Shah TT, Reddy D, Peters M et al. (2021) Focal therapy compared to radical prostatectomy for non-metastatic prostate cancer: a propensity score-matched study. Prostate cancer and prostatic diseases 24(2):567-74

    Propensity score matched study

    n=246

    FU=64 months

    In people with non-metastatic low- intermediate prostate cancer, oncological outcomes over 8 years were similar between focal therapy and radical prostatectomy.

    More recent results presented in van Son, 2021.

    Schmid FA, Schindele D, Mortezavi A et al. (2020) Prospective multicentre study using high intensity focused ultrasound (HIFU) for the focal treatment of prostate cancer: Safety outcomes and complications. Urologic Oncology: Seminars and Original Investigations 38(4):225-30

    Case series

    n=98

    Focal therapy of localised prostate cancer lesions with a robotic HIFU-probe is safe and renders an acceptable rate of minor early AEs. The inclusion of the urethra in the ablation zone leads to an increase in early complications and should be avoided whenever possible

    Studies with more people or longer follow up included.

    Shoji S, Hiraiwa S, Uemura K et al. (2020) Focal therapy with high-intensity focused ultrasound for the localized prostate cancer for Asian based on the localization with MRI-TRUS fusion image-guided transperineal biopsy and 12-cores transperineal systematic biopsy: prospective analysis of oncological and functional outcomes. International journal of clinical oncology 25(10):1844-53

    Case series

    n=90

    FU=21 months

    The present treatment for Asian people would have similar oncological and functional outcomes to those in previous reports. Further large studies are required to verify oncological and functional outcomes from this treatment for people with localised prostate cancer.

    Studies with more people or longer follow up included.

    Sivaraman A, Marra G, Stabile A et al. (2020) Does mpMRI guidance improve HIFU partial gland ablation compared to conventional ultrasound guidance? Early functional outcomes and complications from a single center. International braz j urol: official journal of the Brazilian Society of Urology 46(6):984-92

    Cohort study

    n=140

    FU=12 months

    HIFU focal therapy guided by MRI-ultrasound fusion may allow improved functional outcomes and fewer complications compared to ultrasound-guided HIFU focal therapy alone. Further analysis is needed to confirm benefits of MRI implementation at a longer follow-up and on a larger cohort of people

    Studies with more people or longer follow up included.

    Stabile A, Orczyk C, Giganti F et al. (2020) The Role of Percentage of Prostate-specific Antigen Reduction After Focal Therapy Using High-intensity Focused Ultrasound for Primary Localised Prostate Cancer. Results from a Large Multi-institutional Series. European Urology 78(2):155-60

    Case series

    n=703

    FU=41 months

    The percentage of prostate-specific antigen reduction is a useful tool to assess men following focal therapy. It can assist the urologist in setting up an appropriate follow-up and during post-focal therapy patient counselling.

    This cohort was captured in Stabile, 2019.

    Stabile A, Sanchez-Salas R, Tourinho-Barbosa R et al. (2021) Association between Lesion Location and Oncologic Outcomes after Focal Therapy for Localized Prostate Cancer Using Either High Intensity Focused Ultrasound or Cryotherapy. The Journal of urology 206(3):638-45

    Case series

    n=166

    FU=51 months

    The prostate cancer location does not significantly affect the rate of failure after focal therapy. The presence of an apical lesion should not be considered an exclusion criterion for focal therapy. Both HIFU and cryotherapy likely achieve similar medium-term oncologic results regardless of prostate cancer location.

    Studies with more people or longer follow up included.

    Tourinho-Barbosa RR, Sanchez-Salas R Claros OR et al. (2020) Focal Therapy for Localized Prostate Cancer with Either High Intensity Focused Ultrasound or Cryoablation: A Single Institution Experience. The Journal of urology; 203(2):320-30

    Case series

    n=190

    FU=45 months

    Almost half of the men were free of focal therapy failure 5 years after treatment. Still, a significant proportion experienced recurrence at the midterm follow-up. The preoperative biopsy Gleason score and nadir prostate specific antigen were significantly associated with treatment failure.

    Studies with more people or longer follow up included. Included in the Bakavicius, 2022 systematic review.

    Valerio M, Ahmed HU, Emberton M et al. (2014) The role of focal therapy in the management of localised prostate cancer: a systematic review. European urology 66(4):732-51

    Systematic review

    n=12 studies

    When focal therapy is delivered with intention to treat, the perioperative, functional, and disease control outcomes are encouraging within a short- to medium-term follow-up. Focal therapy is a strategy by which the overtreatment burden of the current prostate cancer pathway could be reduced, but robust comparative effectiveness studies are now required.

    More recent systematic reviews included.

    Valerio M, Cerantola Y, Eggener SE et al. (2017) New and Established Technology in Focal Ablation of the Prostate: A Systematic Review. European urology 71(1):17-34

    Systematic review

    n=13

    Focal therapy has been evaluated using seven sources of energy in single-arm retrospective and prospective development studies up to Stage 2b. Focal therapy seems to have a minor impact on quality of life and genitourinary function. Oncological effectiveness is yet to be defined against standard of care.

    More recent systematic reviews included.

    Valle LF, Lehrer EJ, Markovic D et al. (2020) A Systematic Review and Meta-analysis of Local Salvage Therapies After Radiotherapy for Prostate Cancer (MASTER) European Urology.

    Systematic review and meta-analysis

    Relapse-free survival at 5 years is equivalent among salvage modalities, but reirradiation may lead to lower toxicity. This meta-analysis provides pooled estimates of surgical and nonsurgical local salvage treatments for radiorecurrent prostate cancer. Five-year recurrence-free survival was similar across modalities on meta-regression, although differences in severe genitourinary and gastrointestinal toxicity appear to favour reirradiation, particularly high-dose-rate brachytherapy

    Salvage focal HIFU systematic review (Khoo, 2020) included. Meta-analysis includes whole-gland ablation as well as focal.

    van Velthoven R, Aoun F, Marcelis Q et al. (2016) A prospective clinical trial of HIFU hemiablation for clinically localized prostate cancer. Prostate cancer and prostatic diseases 19 (1):79-83

    Case series

    n=50

    FU=39.5 months

    Hemiablation HIFU therapy, delivered with intention to treat, for carefully selected people affords mid-term promising functional and oncological outcomes. The effectiveness of this technique should be now compared with whole-gland radical therapy.

    Studies with more people or longer follow up included. Included in the Bakavicius, 2022 systematic review.

    Yap T, Ahmed HU, Hindley RG et al. (2016) The Effects of Focal Therapy for Prostate Cancer on Sexual Function: A Combined Analysis of Three Prospective Trials. European urology 69(5):844-51

    Pooled analysis

    n=118

    FU=1 year

    Men who received a range of tissue preserving therapies from the 3 pertinent studies experienced small decreases in total IIEF, erectile, and individual sexual domain scores that are not significantly different to those recorded at baseline. The only determinant of erectile dysfunction after tissue preserving therapy was preoperative erectile dysfunction status. Tissue preservation confers a high probability of maintaining erectile function that appears independent of all perioperative factors with the exception of baseline status.

    Studies with more people or longer follow up included.