Kazuto Ito1,2, Shiro Saito3, Atsunori Yorozu4, Shinsuke Kojima5, Takashi Kikuchi5, Satoshi Higashide5, Manabu Aoki6, Hirofumi Koga7, Takefumi Satoh8,9, Toshio Ohashi10, Katsumasa Nakamura11, Norihisa Katayama12, Nobumichi Tanaka13, Masahiro Nakano14, Naoyuki Shigematsu10, Takushi Dokiya15, Masanori Fukushima5. 1. Department of Urology, Gunma University, Gunma, Japan. kzito@gunma-u.ac.jp. 2. Institute for Preventive Medicine, Kurosawa Hospital, 187, Yanaka-cho, Takasaki, Gunma, 370-1203, Japan. kzito@gunma-u.ac.jp. 3. Department of Urology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan. 4. Department of Radiation Oncology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan. 5. Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Hyogo, Japan. 6. Department of Radiation Oncology, Jikei University School of Medicine, Tokyo, Japan. 7. Seisyukai Clinic, Fukuoka, Japan. 8. Department of Urology, Kitasato University School of Medicine, Kanagawa, Japan. 9. Takefumi Satoh Prostate Clinic, Tokyo, Japan. 10. Department of Radiation Oncology, Keio University School of Medicine, Tokyo, Japan. 11. Department of Radiation Oncology, Hamamatsu University School of Medicine, Shizuoka, Japan. 12. Department of Radiation Oncology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan. 13. Department of Urology, Nara Medical University Hospital, Nara, Japan. 14. Department of Urology, Gifu University Graduate School of Medicine, Gifu, Japan. 15. Department of Radiation Oncology, Saitama Medical College, Saitama, Japan.
Abstract
BACKGROUND: Investigating oncological outcomes in patients registered in the Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS) in terms of biochemical relapse-free survival (bRFS) by the Phoenix and the newly developed J-POPS definitions, exploration of predictive factors for bRFS, and preliminary verification of pitfalls of prostate-specific antigen (PSA) failure definitions. METHODS: Between July 2005 and June 2007, 2316 clinically localized patients underwent permanent seed implantation. The primary endpoint was bRFS. One of the secondary endpoints was overall survival (OS). RESULTS: The median age was 69 and performance status was 0 in 99.1% of participants. The median biologically effective dose (BED) was about 180 Gy2. During a median follow-up of 60.0 months, 8.4 and 5.9% had PSA failure by the Phoenix and the J-POPS definitions, respectively. The 5-year bRFSs based on the Phoenix and the J-POPS definitions were 89.1 and 91.6%, respectively. The 5-year OS was 97.3%. According to multivariate analyses, only age affected bRFS based on the Phoenix definition, whereas the risk group and BED independently affected bRFS based on the J-POPS definition. A spontaneous PSA decrease was seen in 91.1% of participants after PSA failure based on the Phoenix definition alone, but in only 22.2% after PSA failure based on the J-POPS definition alone. CONCLUSION: The world's largest registration study, J-POPS, consisted of patients with longevity, and a highly quality-controlled BED resulted in excellent bRFS and OS. The high likelihood of PSA bounce by the Phoenix definition should be taken into account, especially in younger patients. CLINICAL TRIAL INFORMATION: NCT00534196.
BACKGROUND: Investigating oncological outcomes in patients registered in the Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS) in terms of biochemical relapse-free survival (bRFS) by the Phoenix and the newly developed J-POPS definitions, exploration of predictive factors for bRFS, and preliminary verification of pitfalls of prostate-specific antigen (PSA) failure definitions. METHODS: Between July 2005 and June 2007, 2316 clinically localized patients underwent permanent seed implantation. The primary endpoint was bRFS. One of the secondary endpoints was overall survival (OS). RESULTS: The median age was 69 and performance status was 0 in 99.1% of participants. The median biologically effective dose (BED) was about 180 Gy2. During a median follow-up of 60.0 months, 8.4 and 5.9% had PSA failure by the Phoenix and the J-POPS definitions, respectively. The 5-year bRFSs based on the Phoenix and the J-POPS definitions were 89.1 and 91.6%, respectively. The 5-year OS was 97.3%. According to multivariate analyses, only age affected bRFS based on the Phoenix definition, whereas the risk group and BED independently affected bRFS based on the J-POPS definition. A spontaneous PSA decrease was seen in 91.1% of participants after PSA failure based on the Phoenix definition alone, but in only 22.2% after PSA failure based on the J-POPS definition alone. CONCLUSION: The world's largest registration study, J-POPS, consisted of patients with longevity, and a highly quality-controlled BED resulted in excellent bRFS and OS. The high likelihood of PSA bounce by the Phoenix definition should be taken into account, especially in younger patients. CLINICAL TRIAL INFORMATION: NCT00534196.
Entities:
Keywords:
Brachytherapy; External beam radiation therapy; Iodine-125; Prostate cancer
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