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

• Main Authors: 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
• Format: Article
• Language: English
• Published: Wiley 2021-05-01
• Series: Cancer Medicine
• Subjects: external beam radiation therapy; intermittent androgen deprivation therapy; prostate cancer; QOL; neoadjuvant
• Online Access: https://doi.org/10.1002/cam4.3895

Abstract Background 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). Methods 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. Results 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). Conclusion 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.