Advertisement

Focal High-Intensity Focused Ultrasound vs. Active Surveillance for ISUP Grade 1 Prostate Cancer: Medium-Term Results of a Matched-Pair Comparison

      ABSTRACT

      Introduction/Background

      Only 1 randomized controlled trial has compared focal therapy and active surveillance (AS) for the low-risk prostate cancer (PCa). We investigated whether focal HIFU (fHIFU) yields oncologic advantages over AS for low-risk PCa.

      Materials and Methods

      We included 2 non-randomized prospective series of 132 (fHIFU) and 421 (AS) consecutive patients diagnosed with ISUP 1 PCa between 2008 and 2018. A matched pair analysis was performed to decrease potential bias. Study main outcomes were freedom from radical treatment (RT) or androgen-deprivation therapy (ADT), treatment-free survival (TFS), time to metastasis, and overall survival (OS).

      Results

      Median fHIFU follow-up was 50 months (interquartile range, 29-84 months). Among matched variables, no major differences were recorded except for AS having more suspicious digital rectal examination findings (P = .0074) and recent enrollment year (P = .0005). Five-year intervention-free survival from RT or ADT was higher for the fHIFU cohort (67.4% vs. 53.8%; P = .0158). Time to treatment was approximately 10 months shorter for AS than for fHIFU (time to RT, P = .0363; time to RT or ADT, P = .0156; time to any treatment, P = .0319). No differences were found in any-TFS (fHIFU, 61.4% vs. AS, 53.8%; P = .2635), OS (fHIFU, 97% vs. AS, 97%; P = .9237), or metastasis (n = 0 in fHIFU and n = 2 in AS; P = .4981). Major complications (≥ Clavien 3) were rare (n = 4), although 36.4% of men experienced complications. No relevant changes were noted in continence (P = .3949).

      Conclusion

      At a 4-year median follow-up, fHIFU for mainly low-risk PCa (ISUP grade 1) is safe, may decrease the need for radical treatment or ADT and may allow longer time to treatment compared to AS. Nonetheless, no advantages are seen in PCa progression and/or death (OS).

      Abbreviations and Acronyms:

      FT (focal therapy), PCa (prostate cancer), RCT (randomized controlled trials), OS (overall-survival), fHIFU (focal HIFU), ADT (androgen), FS (free survival), RT (radical treatment), RCT (randomized controlled trial)

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Clinical Genitourinary Cancer
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Marra G
        • Gontero P
        • Valerio M.
        Changing the prostate cancer management pathway: why focal therapy is a step forward.
        Arch Esp Urol. 2016; 69: 271
        • Valerio M
        • Cerantola Y
        • Eggener SE
        New and established technology in focal ablation of the prostate: a systematic review.
        Eur Urol. 2017; 71: 17
        • Jain AL
        • Sidana A
        • Maruf M
        • et al.
        Analyzing the current practice patterns and views among urologists regarding focal therapy for prostate cancer.
        Urol Oncol. 2019; 37 (e1): 182
        • Marra G
        • Ploussard G
        • Ost P
        • et al.
        Focal therapy in localised prostate cancer: real-world urological perspective explored in a cross-sectional European survey.
        Urol Oncol. 2018; 36 (e11): 529
        • Cacciamani GE
        • Bassi S
        • Sebben M
        • et al.
        Consulting “Dr. Google” for prostate cancer treatment options: a contemporary worldwide trend analysis.
        Eur Urol Oncol. 2019; 3: 481
        • van der Poel HG
        • van den Bergh RCN
        • Briers E
        • et al.
        Focal therapy in primary localised prostate cancer: the European Association of Urology position.
        Eur Urol. 2018; 74 (2018): 84
        • Gontero P
        • Marra G
        • Teber D
        • et al.
        Making a case “against” focal therapy for intermediate-risk prostate cancer.
        World J Urol. 2020; 39: 719
        • Hamdy FC
        • Donovan JL
        • Lane JA
        • et al.
        ProtecT Study Group: 10-year outcomes after monitoring, surgery, or radiotherapy for localized prostate cancer.
        N Engl J Med. 2016; 375: 1415
        • Neal DE
        • Metcalfe C
        • Donovan JL
        • et al.
        ProtecT Study Group: Ten-year mortality, disease progression, and treatment-related side effects in men with localised prostate cancer from the ProtecT randomised controlled trial according to treatment received.
        Eur Urol. 2020; 77: 320
        • Azzouzi AR
        • Vincendeau S
        • Barret E
        • et al.
        PCM301 Study Group: Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301): an open-label, phase 3, randomised controlled trial.
        Lancet Oncol. 2017; 18: 181
        • Stabile A
        • Orczyk C
        • Hosking-Jervis F
        • et al.
        Medium-term oncological outcomes in a large cohort of men treated with either focal or hemi-ablation using high-intensity focused ultrasonography for primary localized prostate cancer.
        BJU Int. 2019; 124: 431
        • Abreu AL
        • Peretsman S
        • Iwata A
        • et al.
        High intensity focused ultrasound hemigland ablation for prostate cancer: initial outcomes of a United States series.
        J Urol. 2020; 204: 741
        • Nahar B
        • Bhat A
        • Reis IM
        • et al.
        Prospective evaluation of focal high intensity focused ultrasound for localized prostate cancer.
        J Urol. 2020; 204: 483
        • Shah TT
        • Reddy D
        • Peters M
        • et al.
        Focal therapy compared to radical prostatectomy for non-metastatic prostate cancer: a propensity score-matched study.
        Prostate Cancer Prostatic Dis. 2021 Jun; 24: 567-574https://doi.org/10.1038/s41391-020-00315-y
      1. Epub 2021 Jan 28.
        • Tourinho-Barbosa RR
        • Sanchez-Salas R
        • Claros OR
        • et al.
        Focal therapy for localized prostate cancer with either HIFU or cryoablation: a single institution experience.
        J Urol. 2020; 203: 320
        • Sivaraman A
        • Marra G
        • Stabile A
        Does mpMRI guidance improve HIFU partial gland ablation compared to conventional ultrasound guidance? Early functional outcomes and complications from a single center.
        Int Braz J Urol. 2020; 46: 984
        • Soeterik TFW
        • van Melick HHE
        • Dijksman LM
        Follow-up in active surveillance for prostate cancer: strict protocol adherence remains important for PRIAS-ineligible patients.
        Eur Urol Oncol. 2019; 2: 483
        • van den Bergh RCN
        • Roemeling S
        • Roobol MJ
        • et al.
        Prospective validation of active surveillance in prostate cancer: the PRIAS study.
        Eur Urol. 2007; 52: 1560
        • Bokhorst LP
        • Valdagni R
        • Rannikko A
        • et al.
        A decade of active surveillance in the PRIAS study: an update and evaluation of the criteria used to recommend a switch to active treatment.
        Eur Urol. 2016; 70: 954
        • Mitropoulos D
        • Artibani W
        • Graefen M
        • et al.
        European Association of Urology Guidelines Panel: Reporting and grading of complications after urologic surgical procedures: an ad hoc EAU Guidelines Panel assessment and recommendations.
        Eur Urol. 2012; 61: 341
        • Marra G
        • Dell'oglio P
        • Baghdadi M
        • et al.
        EvaluatioN of HIFU Hemiablation and short-term AndrogeN deprivation therapy Combination to Enhance prostate cancer control (ENHANCE) Study: Multimodal treatment in focal therapy for localized prostate cancer using concomitant short-term androgen deprivation therapy: the ENHANCE prospective pilot study.
        Minerva Urol Nefrol. 2019; 71: 544
        • Thompson JE
        • Sridhar AN
        • Tan WS
        • et al.
        Pathological findings and magnetic resonance imaging concordance at salvage radical prostatectomy for local recurrence following partial ablation using high intensity focused ultrasound.
        J Urol. 2019; 201: 1134
        • Krakowsky Y
        • Loblaw A
        • Klotz L.
        Prostate cancer death of men treated with initial active surveillance: clinical and biochemical characteristics.
        J Urol. 2010; 184: 131
        • Tan WP
        • Rastinehad AR
        • Klotz L
        • et al.
        Focal Therapy Consensus Group: Utilization of focal therapy for patients discontinuing active surveillance of prostate cancer: recommendations of an international Delphi consensus.
        Urol Oncol Semin. 2021 Nov; 39: 781.e17-781.e24https://doi.org/10.1016/j.urolonc.2021.01.027
      2. Epub 2021 Mar 4.
        • Reddy D
        • Shah TT
        • Dudderidge T
        • et al.
        Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (IP4-CHRONOS): a prospective, multi-centre therapeutic phase II parallel randomised control trial.
        Contemp Clin Trials. 2020; 93105999
        • Gharzai LA
        • Jiang R
        • Wallington D
        • et al.
        Intermediate clinical endpoints for surrogacy in localised prostate cancer: an aggregate meta-analysis.
        Lancet Oncol. 2021; 22: 402-410https://doi.org/10.1016/S1470-2045(20)30730-0
        • Peretsman S
        • Brooks J.
        Salvage robotic prostatectomy following whole gland high-intensity focused ultrasound with a Sonablate 500 device: technical feasibility and safety.
        J Rob Surg. 2017; 11: 217-221https://doi.org/10.1007/s11701-016-0649-x
        • Marra G
        • Soeterik T
        • Oreggia D
        • et al.
        Long-term Outcomes of Focal Cryotherapy for Low- to Intermediate-risk Prostate Cancer: Results and Matched Pair Analysis with Active Surveillance.
        Eur Urol Focus. 2021; (S2405-4569(21)00114-0Online ahead of print)https://doi.org/10.1016/j.euf.2021.04.008
        • Marra G
        • Laguna MP
        • Walz J
        • et al.
        Molecular biomarkers in the context of focal therapy for prostate cancer: recommendations of a Delphi Consensus from the Focal Therapy Society.
        Minerva Urol Nefrol. 2021; (Online ahead of print)https://doi.org/10.23736/S0393-2249.20.04160-0