Neoadjuvant radiohormonal therapy for oligo-metastatic prostate cancer: safety and efficacy outcomes from an open-label, dose-escalation, single-center, phase I/II clinical trial

Abstract

To evaluate the safety and efficacy of neoadjuvant radiohormonal therapy for oligometastatic prostate cancer (OMPC), we conducted a 3 + 3 dose escalation, prospective, phase I/II, single-arm clinical trial (CHiCTR1900025743), in which long-term neoadjuvant androgen deprivation was adopted 1 month before radiotherapy, comprising intensity modulated radiotherapy to the pelvis, and stereotactic body radiation therapy to all extra-pelvic bone metastases for 4‒7 weeks, at 39.6, 45, 50.4, and 54 Gy. Robotic-assisted radical prostatectomy was performed after 5‒14 weeks. The primary outcome was treatment-related toxicities and adverse events; secondary outcomes were radiological treatment response, positive surgical margin (pSM), postoperative prostate-specific antigen (PSA), pathological down-grading and tumor regression grade, and survival parameters. Twelve patients were recruited from March 2019 to February 2020, aging 66.2 years in average (range, 52‒80). Median baseline PSA was 62.0 ng/mL. All underwent RARP successfully without open conversions. Ten patients recorded pathological tumor down-staging (83.3%), and 5 (41.7%) with cN1 recorded negative regional lymph nodes on final pathology. 66.7% (8/12) recorded tumor regression grading (TRG) –I and 25% (3/12) recorded TRG-II. Median follow-up was 16.5 months. Mean radiological progression-free survival (RPFS) was 21.3 months, with 2-year RPFS of 83.3%. In all, neoadjuvant radiohormonal therapy is well tolerated for oligometastatic prostate cancer.

Keywords

neoadjuvant / radiotherapy / oligometastatic / prostate cancer / radical prostatectomy

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Acknowledgments

This study is supported by the 2021 Changhai Hospital Educational Sponsorship Fund (No. CHPY2021B24, General Program, YC), the 2021 Naval Medical University Basic Science Research Youth Start-up Fund (No. 2021QN29, YC), the First Affiliated Hospital of Navy Medical University “234 Subject Climbing Program” (No. 2019YPT004, HZ), the First Affiliated Hospital of Naval Medical University “Youth Development Program” (No. 2021JCQNO3, XZ) and the First Affiliated Hospital of Naval Medical University “Youth Startup Fund” (Nos. 2021QN29 and 2020QNB10, XZ).

Electronic Supplementary Material

Supplementary material is available in the online version of this article at https://doi.org/10.1007/s11684-022-0939-9 and is accessible for authorized users.

Compliance with ethics guidelines

Yifan Chang, Xianzhi Zhao, Yutian Xiao, Shi Yan, Weidong Xu, Ye Wang, Huojun Zhang, and Shancheng Ren declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975. Informed consent was obtained from all patients for being included in the study.

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