Patient-reported functional outcomes and oncological control after primary focal cryotherapy for clinically significant prostate cancer: A Phase II mandatory biopsy-monitored study.

التفاصيل البيبلوغرافية
العنوان:	Patient-reported functional outcomes and oncological control after primary focal cryotherapy for clinically significant prostate cancer: A Phase II mandatory biopsy-monitored study.
المؤلفون:	Tan YG; Department of Urology, Singapore General Hospital, Singapore., Law YM; Department of Diagnostic Radiology, Singapore General Hospital, Singapore.; Duke-NUS Medical School, Singapore., Ngo NT; Duke-NUS Medical School, Singapore.; Division of Pathology, Singapore General Hospital, Singapore., Khor LY; Duke-NUS Medical School, Singapore.; Division of Pathology, Singapore General Hospital, Singapore., Tan PH; Duke-NUS Medical School, Singapore.; Division of Pathology, Singapore General Hospital, Singapore., Ong EHW; Division of Medical Sciences, National Cancer Center Singapore, Singapore., Yuen JSP; Department of Urology, Singapore General Hospital, Singapore.; Duke-NUS Medical School, Singapore., Ho HSS; Department of Urology, Singapore General Hospital, Singapore.; Duke-NUS Medical School, Singapore., Tuan JKL; Duke-NUS Medical School, Singapore.; Division of Radiation Oncology, National Cancer Center Singapore, Singapore., Kanesvaran R; Duke-NUS Medical School, Singapore.; Division of Medical Oncology, National Cancer Center Singapore, Singapore., Gupta RT; Department of Radiology, Duke Cancer Centre, Singapore., Rozen S; Department of Bioinformatics, Duke-NUS Medical School, Singapore., Chua MLK; Duke-NUS Medical School, Singapore.; Division of Medical Sciences, National Cancer Center Singapore, Singapore.; Division of Radiation Oncology, National Cancer Center Singapore, Singapore., Polascik TJ; Department of Urology, Duke Cancer Centre, Singapore., Tay KJ; Department of Urology, Singapore General Hospital, Singapore.; Duke-NUS Medical School, Singapore.
المصدر:	The Prostate [Prostate] 2023 Jun; Vol. 83 (8), pp. 781-791. Date of Electronic Publication: 2023 Mar 09.
نوع المنشور:	Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
اللغة:	English
بيانات الدورية:	Publisher: Wiley-Liss Country of Publication: United States NLM ID: 8101368 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-0045 (Electronic) Linking ISSN: 02704137 NLM ISO Abbreviation: Prostate Subsets: MEDLINE
أسماء مطبوعة:	Publication: <2005-> : Hoboken, NJ : Wiley-Liss Original Publication: New York : Alan R. Liss, c1980-
مواضيع طبية MeSH:	Prostate-Specific Antigen* , Prostatic Neoplasms*/pathology, Male ; Humans ; Aged ; Prospective Studies ; Magnetic Resonance Imaging/methods ; Biopsy ; Cryotherapy/methods
مستخلص:	Introduction: We report herein the impact of focal therapy (FT) on multi-domain functional outcomes in a Phase II prospective clinical trial (NCT04138914) in focal cryotherapy for clinically significant prostate cancer (csPCa). Methods: The primary outcome was the detection of a ≥5 point deterioration in any of the four main expanded prostate index composite (EPIC) functional domains. Pretreatment multiparametric magnetic resonance imaging (mpMRI) and transperineal targeted and systematic saturation biopsy were used to select patients with prostate-specific antigen (PSA)≤20 ng/mL, Gleason grade group (GG) ≤4, mpMRI lesion volume ≤ 3 mL (for a single lesion) or ≤1.5 mL (where two lesions were present). Focal cryotherapy was performed with a minimum 5 mm margin around each target lesion. EPIC scores were obtained at baseline and posttreatment at 1, 3, 6, and 12 months. Mandatory repeat mpMRI and prostate biopsy were performed at 12 months to determine the infield and outfield recurrence. Results: Twenty-eight patients were recruited. The mean age was 68 years, with PSA of 7.3 ng/mL and PSA density of 0.19 ng/mL ² . No Clavien-Dindo ≥3 complications occurred. Transient worsening of EPIC urinary (mean diff 16.0, p < 0.001, 95% confidence interval [CI]: 8.8-23.6) and sexual function scores (mean diff 11.0, p:0.005, 95% CI: 4.0-17.7) were observed at 1-month posttreatment, with recovery by Month 3. A subgroup who had ablation extending to the neurovascular bundle had a trend to delayed recovery of sexual function to Month 6. At 12-month repeat mpMRI and biopsy, 22 patients (78.6%) had no detectable csPCa. Of the six patients (21.4%) who had csPCa recurrences, four were GG2, one GG3, and one GG4. Four patients underwent repeat FT, one underwent radical prostatectomy, while the remaining one patient with low-volume GG2 cancer opted for active surveillance. Conclusion: FT using cryotherapy was associated with a transient deterioration of urinary and sexual function with resolution at 3 months posttreatment and with reasonable early efficacy in well-selected csPCa patients. (© 2023 The Authors. The Prostate published by Wiley Periodicals LLC.)
References:	Curr Opin Urol. 2019 Nov;29(6):563-568. (PMID: 31436569) Eur Urol Focus. 2019 Jul;5(4):585-591. (PMID: 29102671) Prostate Cancer Prostatic Dis. 2022 Apr;25(4):720-726. (PMID: 35027690) World J Urol. 2015 Jul;33(7):955-64. (PMID: 25944676) Lancet. 2017 Feb 25;389(10071):815-822. (PMID: 28110982) Urol Oncol. 2018 Feb;36(2):67-76. (PMID: 29277585) Eur Urol. 2022 Jan;81(1):5-33. (PMID: 34489140) Prostate Cancer Prostatic Dis. 2017 Sep;20(3):294-299. (PMID: 28349978) Prostate. 2023 Jun;83(8):781-791. (PMID: 36895163) N Engl J Med. 2013 Jan 31;368(5):436-45. (PMID: 23363497) BJU Int. 2021 Aug;128(2):178-186. (PMID: 33539650) Eur Urol. 2021 Feb;79(2):243-262. (PMID: 33172724) Eur Urol Focus. 2015 Sep;1(2):137-146. (PMID: 28723424) Eur Urol. 2019 Jul;76(1):98-105. (PMID: 30638633) J Clin Oncol. 2015 Jan 20;33(3):272-7. (PMID: 25512465) Eur Urol. 2012 Apr;61(4):664-75. (PMID: 22169079) J Urol. 2019 Dec;202(6):1188-1198. (PMID: 31347953) J Urol. 2020 Feb;203(2):320-330. (PMID: 31437121) JAMA Oncol. 2022 Jan 01;8(1):50-59. (PMID: 34792527) Radiology. 2017 Nov;285(2):620-628. (PMID: 28654336) Eur Urol Focus. 2022 Jul;8(4):926-941. (PMID: 34580049) Eur Urol. 2017 Jan;71(1):17-34. (PMID: 27595377) Eur Urol. 2021 Nov;80(5):549-563. (PMID: 34020828) Eur Urol. 2019 Jul;76(1):43-51. (PMID: 30824296) Curr Urol Rep. 2016 Oct;17(10):69. (PMID: 27502428) J Urol. 2020 Nov;204(5):941-949. (PMID: 32985924)
فهرسة مساهمة:	Keywords: clinically significant prostate cancer; cryotherapy; focal therapy; functional outcomes
سلسلة جزيئية:	ClinicalTrials.gov NCT04138914
المشرفين على المادة:	EC 3.4.21.77 (Prostate-Specific Antigen)
تواريخ الأحداث:	Date Created: 20230310 Date Completed: 20230424 Latest Revision: 20240322
رمز التحديث:	20240322
مُعرف محوري في PubMed:	PMC10952298
DOI:	10.1002/pros.24517
PMID:	36895163
قاعدة البيانات:	MEDLINE

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تدمد:	1097-0045
DOI:	10.1002/pros.24517