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  • [Radiat Oncol.] Phase I/IIa trial of androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost for high-risk prostate cancer (ADEBAR)

    [Radiat Oncol.] Phase I/IIa trial of androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost for high-risk prostate cancer (ADEBAR)

    울산의대 / 김연주, 김영석*

  • 출처
    Radiat Oncol.
  • 등재일
    2020 Oct 8
  • 저널이슈번호
    15(1):234. doi: 10.1186/s13014-020-01665-6.
  • 내용

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    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.

     

     

     

    Affiliations

    Yeon Joo Kim  1 , Hanjong Ahn  2 , Choung-Soo Kim  2 , Young Seok Kim  3
    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.
    2 Department of Urology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Republic of Korea.
    3 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. ysk@amc.seoul.kr.

  • 키워드
    Prostate neoplasms; Quality of life; Radiosurgery; Radiotherapy; Toxicity.
  • 연구소개
    고위험군 전립선암의 표준치료는 호르몬차단 + 방사선치료이다. 통상적으로 방사선치료는 세기변조방사선치료 기법을 이용하여, 주5일, 7-8주를 시행하게 되는데, 본 연구에서는 정위적방사선수술을 사용하여 5주에 치료를 안전하게 마무리할 수 있는지 초첨을 맞추었다. 무작위 비교 연구결과, 독성을 증가시키지 않으면서 안전하게 치료기간을 단축시킴을 보여, 향후 표준치료로서 3상 연구가 필요할 것으로 결론내렸다.
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