Patient-reported outcomes following neoadjuvant endocrine therapy, external beam radiation, and adjuvant continuous/intermittent endocrine therapy for locally advanced prostate cancer: A randomized phase III trial.

We evaluated patient-reported outcomes (PRO) during neoadjuvant androgen deprivation therapy (ADT) plus external beam radiation therapy (EBRT) followed by either adjuvant continuous ADT (CADT) or intermittent ADT (IADT) for patients with locally advanced prostate cancer (Pca).

A multicenter, randomized phase III trial enrolled 303 patients with locally advanced Pca. The patients were treated with 6 months (M) of ADT followed by 72 Gy of EBRT, and were randomly assigned to CADT or IADT after 14 M. The PROs were evaluated at sic points: baseline, 6 M, 8 M, 14 M, 20 M, and 38 M using FACT-P questionnaires and EPIC urinary, bowel, and sexual bother subscales.

The FACT-P total scores were significantly better (p < 0.05) in IADT versus CADT at 20 M (121.6 vs.115.4) and at 38 M (119.9 vs. 115.2). The physical well-being scores (PWB) were significantly better (p < 0.05) in IADT versus CADT at 38 M (25.4 vs. 24.0). The functional scores were significantly better in IADT than those in CADT at 14 M (20.2 vs18.7, p < 0.05) and at 20 M (21.0 vs.18.9, p < 0.05).

The PRO was significantly favorable in IADT on FACT-P total score at 20 M and 38 M, PWB and functional scores at 38 M.

Cancer medicine. 2021 May 01 [Epub ahead of print]

Akira Yokomizo, Hirofumi Koga, Kazuto Ito, Yutaka Takezawa, Motokiyo Komiyama, Kazuo Nishimura, Junji Yonese, Katsuyoshi Hashine, Naoya Masumori, Gaku Arai, Shiro Saito, Mitsuru Shinohara, Nobuaki Shimizu, Atsushi Yamauchi, Takefumi Satoh, Tatsuo Tochigi, Mikio Kobayashi, Hiroyuki Fujimoto, Ken-Ichi Kakimoto, Iwao Fukui, Taiji Tsukamoto, Miwako Nozaki, Katsuyuki Karasawa, Masaru Hasumi, Mikinobu Ohtani, Hiromichi Ishiyama, Masaaki Kuwahara, Masaoki Harada, Yasuo Ohashi, Toshihiko Kotake, Tadao Kakizoe, Kazuhiro Suzuki, Seiji Naito, Hidetoshi Yamanaka, National Research Project on Endocrine-Radiation Combination Therapy for Locally Advanced Prostate Cancer investigators

Department of Urology, Graduate School of Medicine, Kyusyu University, Fukuoka, Japan., Department of Urology, Gunma University Graduate School of Medicine, Maebashi, Japan., Department of Urology, Isesaki Municipal Hospital, Isesaki, Japan., Department of Urology, National Cancer Center Hospital, Tokyo, Japan., Department of Urology, Osaka International Cancer Institute, Osaka, Japan., Department of Urology, Cancer Institute Hospital, Tokyo, Japan., Department of Urology, Shikoku Cancer Center, Matsuyama, Japan., Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan., Department of Urology, Dokkyo University Koshigaya Hospital, Koshigaya, Japan., Department of Urology, Tokyo Medical Center, Tokyo, Japan., Department of Urology, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan., Department of Urology, Gunma Cancer Center Hospital, Ohta, Japan., Department of Urology, Ibaraki Prefectural Central Hospital, Kasama, Japan., Department of Urology, Kitasato University School of Medicine, Sagamihara, Japan., Department of Urology, Miyagi Cancer Center, Natori, Japan., Sapporo Medical University School of Medicine, Sapporo, Japan., Department of Radiation Oncology, Dokkyo University Koshigaya Hospital, Koshigaya, Japan., Department of Radiation Oncology, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan., Department of Radiation and Radiation Oncology, Kitasato University, Sagamihara, Japan., Sendai Jin-hinyokika, Sendai, Japan., Kanagawa Cancer Center, Yokohama, Japan., University of Tokyo, Tokyo, Japan., Kotake Clinic, Osaka, Japan., President, Japan Cancer Society, Tokyo, Japan., Institute for Preventive Medicine, Kurosawa Hospital, Takasaki, Japan.