Nationwide Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS)

• Published in: International journal of clinical oncology 2015-04, Vol.20 (2), p.375-385
• Main Authors: Saito, Shiro, Ito, Kazuto, Yorozu, Atsunori, Aoki, Manabu, Koga, Hirofumi, Satoh, Takefumi, Ohashi, Toshio, Shigematsu, Naoyuki, Maruo, Shinichiro, Kikuchi, Takashi, Kojima, Shinsuke, Dokiya, Takushi, Fukushima, Masanori, Yamanaka, Hidetoshi
• Format: Article
• Language: English
• Subjects: Adenocarcinoma - blood; Adenocarcinoma - radiotherapy; Adenocarcinoma - therapy; Aged; Aged, 80 and over; Androgen Antagonists - therapeutic use; Brachytherapy - adverse effects; Brachytherapy - methods; Cancer Research; Clinical outcomes; Combined Modality Therapy; Disease-Free Survival; Humans; Iodine Radioisotopes - adverse effects; Iodine Radioisotopes - therapeutic use; Japan; Male; Medicine; Medicine & Public Health; Middle Aged; Oncology; Original Article; Prospective Studies; Prostate cancer; Prostate-Specific Antigen - blood; Prostatic Neoplasms - blood; Prostatic Neoplasms - radiotherapy; Prostatic Neoplasms - therapy; Quality of Life; Radiation Dosage; Radiation therapy; Surgical Oncology; Survival Rate
• ISSN: 1341-9625; 1437-7772
• DOI: 10.1007/s10147-014-0704-4

Background To evaluate the safety and efficacy of brachytherapy with permanent iodine-125 seed implantation (PI) for prostate cancer. The nationwide Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS) has continued since July 2005. This manuscript presents the rationale, J-POPS study design, and the characteristics of initial participants enrolled in this study from July 2005 to June 2007. Methods All participants were treated with PI in accordance with the American Brachytherapy Society recommendations. The primary outcome measure was biochemical progression-free survival. Progression-free survival, overall survival, cause-specific survival, longitudinal changes in health-related quality of life, disease-specific quality of life, the International Prostate Symptom Score, and the incidence of adverse events were also investigated as secondary outcome measurements. Results Overall, 6,927 patients were enrolled by the end of 2010, that is approximately 40 % of all cases treated around the country. During the first 2 years, 2,354 participants were enrolled and 2,339 were actually treated with PI. The age range of participants was 45 to 89 years (median 69 years) and their risk classifications were 1,037 (44.3 %) at low risk, 1,126 (48.1 %) at intermediate risk, and 134 (5.7 %) at high risk, in addition to 16 participants whose classification was unknown. Of all patients, 76.6 % were treated with PI without external beam radiation therapy and 49.3 % received neoadjuvant hormone therapy. Conclusions The J-POPS, a nationwide prospective cohort study that enrolled approximately 40 % of all PI cases in Japan, will provide highly reliable evidence, including outcomes and quality of life, after long-term follow-up.