No standard therapy has been established for localised prostate cancer patients with prostate-specific antigen (PSA) failure after radical prostatectomy (RP).
To determine whether radiotherapy ± hormone therapy is superior to hormone therapy alone in such patients.
This study is a multicentre, randomised, open-label, phase 3 trial. Patients with localised prostate cancer whose PSA concentrations had decreased to <0.1 ng/ml after RP, and then increased to 0.4-1.0 ng/ml, were randomised to the salvage hormone therapy (SHT) group (80 mg bicalutamide [BCL] followed by luteinising hormone-releasing hormone agonist in case of BCL failure) or the salvage radiation therapy (SRT) ± SHT group (64.8 Gy of SRT followed by the same regimen as in the SHT group in case of SRT failure). From May 2004 to May 2011, 210 patients (105 in each arm) were registered, with the median follow-up being 5.5 yr.
The primary endpoint was time to treatment failure (TTF) of BCL.
TTF of BCL was significantly longer in the SRT ± SHT group (8.6 yr) than in the SHT group (5.6 yr; hazard ratio 0.56, 90% confidence interval [0.40-0.77]; one-sided p = 0.001). Thirty-two of 102 patients (31%) in the SRT ± SHT group did not have SRT treatment failure. However, clinical relapse-free survival and overall survival did not differ between the arms. The most frequent grade 3-4 adverse event was erectile dysfunction (83 patients [80%] in the SHT group vs. 76 [74%] in the SRT ± SHT group). Limitations include the short follow-up periods and surrogate endpoint setting to allow definitive conclusions.
Initial SRT prolongs TTF of BCL in patients with post-RP PSA failure, indicating that SRT ± SHT is more beneficial than SHT alone.
Patients who have prostate-specific antigen failure after radical prostatectomy benefit from salvage radiation therapy prior to salvage hormone therapy.
European urology. 2019 Dec 19 [Epub ahead of print]
Akira Yokomizo, Masashi Wakabayashi, Takefumi Satoh, Katsuyoshi Hashine, Takahiro Inoue, Kiyohide Fujimoto, Shin Egawa, Tomonori Habuchi, Kiyotaka Kawashima, Osamu Ishizuka, Nobuo Shinohara, Mikio Sugimoto, Yasushi Yoshino, Keiji Nihei, Haruhiko Fukuda, Ken-Ichi Tobisu, Yoshiyuki Kakehi, Seiji Naito, JCOG0401 Investigators
Department of Urology, Harasanshin Hospital, Fukuoka, Japan., Japan Clinical Oncology Group Data Centre/Operations Office, National Cancer Centre Hospital, Tokyo, Japan., Department of Urology, Kitasato University School of Medicine, Kanagawa, Japan., Department of Urology, National Hospital Organization Shikoku Cancer Centre, Ehime, Japan., Department of Urology, Kyoto University Hospital, Kyoto, Japan., Department of Urology, Nara Medical University, Nara, Japan., Department of Urology, Jikei University Hospital, Tokyo, Japan., Department of Urology, Akita University Graduate School of Medicine, Akita, Japan., Department of Urology, Tochigi Cancer Centre, Tochigi, Japan., Department of Urology, Shinshu University School of Medicine, Nagano, Japan., Department of Renal and Genitourinary Surgery, Hokkaido University Hospital, Hokkaido, Japan., Department of Urology, Faculty of Medicine, Kagawa University, Kagawa, Japan., Department of Urology, Nagoya University School of Medicine, Nagoya, Japan., Division of Radiation Oncology, Tokyo Metropolitan Cancer and Infectious Diseases Centre, Komagome Hospital, Bunkyo City, Japan., Tokyo Metropolitan Cancer and Infectious disease Centre, Komagome Hospital, Bunkyo City, Japan., Department of Urology, Harasanshin Hospital, Fukuoka, Japan. Electronic address: .