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.
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Acknowledgements
Thanks to all of the investigators who contributed to the cohort 1 in the J-POPS (see list of the J-POPS Investigators). This research was supported by the Foundation for Biomedical Research and Innovation (Kobe, Japan; http://www.ibri-kobe.org/english/foundation.html). This work was supported in part by a Health Labor Sciences Research Grant from the Japanese Ministry of Health, Labor and Welfare (H29-ICT-Ippan-002).
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Kazuto Ito received honoraria from Takeda Pharmaceutical Company Limited, AstraZeneca and Astellas. Shiro Saito received honoraria from Takeda Pharmaceutical Company Limited, AstraZeneca, and Astellas and received grant support from Takeda Pharmaceutical Company Limited, AstraZeneca, and Astellas. None of the remaining authors has conflicts of interest that could be perceived as prejudicing the impartiality of the research reported and none has any financial support from industrial companies that are related with this research.
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Investigators in the Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS) are listed in the Supplementary Appendix.
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Ito, K., Saito, S., Yorozu, A. et al. Nationwide Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS): first analysis on survival. Int J Clin Oncol 23, 1148–1159 (2018). https://doi.org/10.1007/s10147-018-1309-0
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DOI: https://doi.org/10.1007/s10147-018-1309-0