دورية أكاديمية
أعرض في EDS

Long-Term Results of a Phase 3 Randomized Prospective Trial of Erectile Tissue-Sparing Intensity-Modulated Radiation Therapy for Men With Clinically Localized Prostate Cancer.

التفاصيل البيبلوغرافية
العنوان: Long-Term Results of a Phase 3 Randomized Prospective Trial of Erectile Tissue-Sparing Intensity-Modulated Radiation Therapy for Men With Clinically Localized Prostate Cancer.
المؤلفون: Zhang E; Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania., Ruth KJ; Department of Biostatistics, Fox Chase Cancer Center, Philadelphia, Pennsylvania., Buyyounouski MK; Department of Radiation Oncology, Stanford University, Stanford, California., Price RA Jr; Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania., Uzzo RG; Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania., Sobczak ML; Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania., Pollack A; Department of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida., Wong JK; Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania., Chen DYT; Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania., Hallman MA; Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania., Greenberg RE; Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania., Watkins-Bruner D; Emory University, Atlanta, Georgia., Al-Saleem T; Department of Pathology, Fox Chase Cancer Center, Philadelphia, Pennsylvania., Horwitz EM; Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania. Electronic address: eric.horwitz@fccc.edu.
المصدر: International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2023 Apr 01; Vol. 115 (5), pp. 1074-1084. Date of Electronic Publication: 2022 Dec 23.
نوع المنشور: Randomized Controlled Trial; Clinical Trial, Phase III; Journal Article; Research Support, N.I.H., Extramural
اللغة: English
بيانات الدورية: Publisher: Elsevier, Inc Country of Publication: United States NLM ID: 7603616 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-355X (Electronic) Linking ISSN: 03603016 NLM ISO Abbreviation: Int J Radiat Oncol Biol Phys Subsets: MEDLINE
أسماء مطبوعة: Publication: New York, NY : Elsevier, Inc
Original Publication: Elmsford, N. Y., Pergamon Press.
مواضيع طبية MeSH: Radiotherapy, Intensity-Modulated*/adverse effects , Radiotherapy, Intensity-Modulated*/methods , Prostatic Neoplasms*/radiotherapy , Prostatic Neoplasms*/pathology , Erectile Dysfunction*/etiology, Male ; Humans ; Prospective Studies ; Radiotherapy Dosage ; Androgen Antagonists ; Single-Blind Method
مستخلص: Purpose: The objective of this study was to determine whether limiting the doses delivered to the penile bulb (PB) and corporal bodies with intensity modulated radiation therapy (IMRT) preserves erectile function compared with standard IMRT in men with prostate cancer.
Methods and Materials: A total of 117 patients with low- to intermediate-risk, clinical T1a-T2c prostate adenocarcinoma were enrolled in a single-institution, prospective, single-blind, phase 3 randomized trial. All received definitive IMRT to 74 to 80 Gy in 37 to 40 fractions and standard IMRT (s-IMRT) or erectile tissue-sparing IMRT (ETS-IMRT), which placed additional planning constraints that limited the D90 to the penile bulb and corporal bodies to ≤15 Gy and ≤7 Gy, respectively. Erectile potency was assessed with components of the International Index of Erectile Function and phosphodiesterase type 5 inhibitor (PDE5) medication records.
Results: Sixty-two patients received ETS-IMRT, and 54 received s-IMRT; 1 patient did not receive radiation therapy. Before treatment, all patients reported erectile potency. No patients received androgen deprivation therapy. In the intention-to-treat analysis, treatment arms did not differ in potency preservation at 24 months (37.1% ETS-IMRT vs 31.5% s-IMRT, P = .53). Of 85 evaluable patients with International Index of Erectile Function and PDE5 medication follow-up, erectile potency was seen in 47.9% of patients in the ETS-IMRT arm and 46.0% of patients in the s-IMRT arm (P = .86). PDE5 inhibitors were initiated in 41.7% of ETS-IMRT patients and 35.1% of s-IMRT patients (P = .54). Among all patients enrolled, there was no difference in freedom from biochemical failure between those treated with ETS-IMRT and s-IMRT (5-year 91.8% vs 90.7%, respectively, P = .77), with a median follow-up of 7.4 years. There were no differences in acute or late gastrointestinal or genitourinary toxicity. An unplanned per-protocol analysis demonstrated no differences in potency preservation or secondary endpoints between patients who exceeded erectile tissue-sparing constraints and those who met constraints, although power was limited by attrition and unplanned dosimetric crossover.
Conclusions: ETS-IMRT that strictly limits dose to the penile bulb and corporal bodies is safe and feasible. Use of this planning technique did not show an effect on potency preservation outcomes at 2 years, though power to detect a difference was limited.
(Copyright © 2022 Elsevier Inc. All rights reserved.)
References: Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):437-47. (PMID: 15890585)
Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):155-63. (PMID: 16111584)
Int J Radiat Oncol Biol Phys. 2004 Jul 15;59(4):1039-46. (PMID: 15234037)
J Clin Oncol. 1997 Jan;15(1):223-9. (PMID: 8996146)
J Urol. 1995 Feb;153(2):372-7. (PMID: 7815587)
JAMA. 2014 Apr 2;311(13):1300-7. (PMID: 24691606)
Cancer. 2002 Oct 15;95(8):1773-85. (PMID: 12365027)
Int J Radiat Oncol Biol Phys. 2001 Jul 1;50(3):597-604. (PMID: 11395225)
Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):426-35. (PMID: 15145159)
Brachytherapy. 2002;1(2):90-4. (PMID: 15062176)
Radiother Oncol. 2006 Sep;80(3):355-62. (PMID: 16949694)
Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):681-93. (PMID: 11849790)
JAMA. 1993 Jul 7;270(1):83-90. (PMID: 8510302)
Strahlenther Onkol. 2012 Nov;188(11):997-1002. (PMID: 23053160)
Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1357-63. (PMID: 15590165)
Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):965-74. (PMID: 16798415)
J Clin Oncol. 1991 Feb;9(2):328-34. (PMID: 1988579)
Prostate Cancer Prostatic Dis. 2007;10(2):189-93. (PMID: 17189954)
Urology. 1999 Dec;54(6):1028-34. (PMID: 10604703)
Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):743-9. (PMID: 14967429)
Urology. 2001 May;57(5):955-9. (PMID: 11337302)
Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1351-6. (PMID: 15590164)
Urology. 2002 May;59(5):692-7. (PMID: 11992842)
Int J Radiat Oncol Biol Phys. 2008 Jul 1;71(3):795-800. (PMID: 18164862)
Int J Radiat Oncol Biol Phys. 2002 Nov 15;54(4):1055-62. (PMID: 12419431)
Radiology. 1995 Apr;195(1):95-9. (PMID: 7534430)
Eur Urol. 2017 Oct;72(4):617-624. (PMID: 28233591)
Urology. 2001 Nov;58(5):828. (PMID: 11711377)
Int J Impot Res. 1999 Dec;11(6):319-26. (PMID: 10637462)
Cancer. 2015 Jul 15;121(14):2422-30. (PMID: 25847819)
معلومات مُعتمدة: P30 CA006927 United States CA NCI NIH HHS
المشرفين على المادة: 0 (Androgen Antagonists)
تواريخ الأحداث: Date Created: 20221225 Date Completed: 20230320 Latest Revision: 20230829
رمز التحديث: 20230830
مُعرف محوري في PubMed: PMC10462387
DOI: 10.1016/j.ijrobp.2022.12.008
PMID: 36566906
قاعدة البيانات: MEDLINE
الوصف
تدمد:1879-355X
DOI:10.1016/j.ijrobp.2022.12.008