Phase I/IIa trial of androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost
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RESEARCH
Open Access
Phase I/IIa trial of androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost for high-risk prostate cancer (ADEBAR) Yeon Joo Kim1, Hanjong Ahn2, Choung-Soo Kim2 and Young Seok Kim1*
Abstract Background: To evaluate the clinical outcomes of combination of androgen deprivation therapy (ADT), whole pelvic radiotherapy (WPRT), and stereotactic body radiotherapy (SBRT) boost in high-risk prostate cancer patients. Methods: This prospective phase I/IIa study was conducted between 2016 and 2017. Following WPRT of 44 Gy in 20 fractions, patients were randomized to two boost doses, 18 Gy and 21 Gy, in 3 fractions using the Cyberknife system. Primary endpoints were incidences of acute toxicities and short-term biochemical recurrence-free survival (BCRFS). Secondary endpoints included late toxicities and short-term clinical progression-free survival (CPFS). Results: A total of 26 patients were enrolled. Twelve patients received a boost dose of 18 Gy, and the rest received 21 Gy. The Median follow-up duration was 35 months. There were no grade ≥ 3 genitourinary (GU) or gastrointestinal (GI) toxicities. Sixty-one and 4% of patients experienced grade 1–2 acute GU and GI toxicities, respectively. There were 12% late grade 1–2 GU toxicities and 8% late grade 1–2 GI toxicities. Patient-reported outcomes of urinary symptoms were aggravated after WPRT and SBRT boost. However, they resolved at 1 month and returned to the baseline level at 4 months. Three-year BCRFS was 88.1%, and CPFS was 92.3%. Conclusions: The present study protocol demonstrated that the combination of ADT, WPRT, and SBRT boosts for high-risk prostate cancer is safe and feasible, and may reduce total treatment time to 5 weeks. Boost dose of 21 Gy in 3 fractions seems appropriate. Trial registration: ClinicalTrials.gov, ID; NCT03322020 - Retrospectively registered on 26 October 2017. Keywords: Prostate neoplasms, Radiotherapy, Radiosurgery, Toxicity, Quality of life
Background For patients affected by intermediate- and high-risk prostate cancer, dose-escalated external beam radiotherapy (EBRT) with a dose range of 76 to 80 Gy has demonstrated improved tumor control with low rates of * Correspondence: [email protected] 1 Department of Radiation Oncology, Asan Medical Center, University of Ulsan, College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea Full list of author information is available at the end of the article
gastrointestinal (GI) and genitourinary (GU) toxicities [1, 2]. These dose-escalated regimens are delivered in conventional fractionation schemes (1.8–2 Gy/fraction) with a treatment duration of 8–9 weeks. Because prostate cancer has a low alpha-beta ratio compared to adjacent normal organs [3], hypofractionation is a feasible strategy for improving clinical outcomes and shortening treatment time. There is increasing use of high-dose-rate brachytherapy (HDRB) boost combined with EBRT, and the results are promising [4, 5]. However, brachytherapy
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