Stereotactic Body Proton Therapy Versus Conventionally Fractionated Proton Therapy for Early Prostate Cancer: A Randomized, Controlled, Phase 3 Trial.

Autor:	Toesca DAS; Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona., Hartsell WF; Proton Collaborative Group, Warrenville, Illinois; Radiation Oncology Consultants, Elk Grove Village, Illinois., DeWees TA; Division of Biostatistics, City of Hope, Duarte, California., Chang JH; University of Oklahoma Health Science Center, Oklahoma City, Oklahoma., Laughlin BS; Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona., Voss MM; Department of Quantitative Health Sciences, Mayo Clinic, Scottsdale, Arizona., Dodoo CA; Department of Quantitative Health Sciences, Mayo Clinic, Scottsdale, Arizona., Mohammed N; Proton Collaborative Group, Warrenville, Illinois; Radiation Oncology Consultants, Elk Grove Village, Illinois., Keole SR; Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona., McGee LA; Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona., Gondi V; Northwestern Medicine Cancer Center Warrenville and Proton Center, Warrenville, Illinois., Sweeney PJ; Northwestern Medicine Cancer Center Warrenville and Proton Center, Warrenville, Illinois., Dorn P; Denver Radiation Oncology, Denver, Colorado., Sinesi CC; Hampton University Proton Therapy Institute, Hampton, Virginia., Doh LS; Integris Health, Oklahoma City, Oklahoma., Rich T; Radiation Medicine Associates, Oklahoma City, Oklahoma., Vargas CE; Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona. Electronic address: Vargas.Carlos@mayo.edu.
Jazyk:	angličtina
Zdroj:	International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2024 Dec 01; Vol. 120 (5), pp. 1377-1385. Date of Electronic Publication: 2024 Jul 06.
DOI:	10.1016/j.ijrobp.2024.05.014
Abstrakt:	Purpose: We aimed to determine if ultrahypofractionated proton therapy delivered via stereotactic body proton therapy (SBPT) is noninferior to conventionally fractionated proton therapy (CFPT) in patients with early prostate cancer. Methods and Materials: This study was a multicenter, randomized, controlled, noninferiority phase 3 trial that included patients with histologically confirmed low-risk prostate adenocarcinoma defined by Gleason score grouping 1, Prostate-specific antigen <10 ng/mL, and clinical stage T1-T2a N0 M0 according to 7th edition of the American Joint Committee on Cancer tumor-node-metastasis cancer staging system. Eligible participants were randomly assigned initially at a 1:1 ratio and later at a 2:1 ratio to SBPT (38 Gy in 5 fractions) or CFPT (79.2 Gy in 44 fractions). The primary endpoint was freedom from failure (FFF) at 2 years from the date of randomization. Noninferiority for FFF was determined based on 1-sided confidence intervals. Toxicities were compared at different time points using Fisher's exact test. Health-related quality-of-life (HRQoL) was analyzed at different time points using a mixed-effects linear model. This trial is registered with ClinicalTrials.gov, NCT01230866, and is closed to accrual. Results: Between December 10, 2010, and September 29, 2020, 144 patients were enrolled and 135 were randomly assigned (90 to the SBPT group and 45 to the CFPT group). The median follow-up was 5 years (IQR, 3.9-5.2). The 2-year FFF was 100% for both groups, with the 1-sided 5-year risk difference in FFF between groups reported as 2.63% (90% CI, -1.70% to 6.96%), favoring the SBRT arm, thus fulfilling the prespecified criteria for noninferiority of SBPT compared with CFPT. Rates of gastrointestinal and genitourinary G2 and G3 toxicities did not differ significantly between groups. Further, HRQoL metrics did not differ significantly between groups over the study's median follow-up. Conclusions: SBPT is noninferior to CFPT regarding FFF, with similar long-term genitourinary and gastrointestinal toxicity rates and minimal impact in patient-reported HRQoL over time. (Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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