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.
10.1007/s11684-022-0939-9
- Author:
Yifan CHANG
1
;
Xianzhi ZHAO
2
;
Yutian XIAO
1
;
Shi YAN
1
;
Weidong XU
3
;
Ye WANG
1
;
Huojun ZHANG
4
;
Shancheng REN
5
Author Information
1. Department of Urology, Shanghai Changhai Hospital, Naval Medical University, Shanghai, 200433, China.
2. Department of Radiation Oncology, Shanghai Changhai Hospital, Naval Medical University, Shanghai, 200433, China.
3. Department of Urology, Shanghai Changzheng Hospital, Naval Medical University, Shanghai, 200003, China.
4. Department of Radiation Oncology, Shanghai Changhai Hospital, Naval Medical University, Shanghai, 200433, China. huojunzh@163.com.
5. Department of Urology, Shanghai Changzheng Hospital, Naval Medical University, Shanghai, 200003, China. renshancheng@gmail.com.
- Publication Type:Journal Article
- Keywords:
neoadjuvant;
oligometastatic;
prostate cancer;
radical prostatectomy;
radiotherapy
- MeSH:
Male;
Humans;
Prostatic Neoplasms/radiotherapy*;
Prostate-Specific Antigen/therapeutic use*;
Neoadjuvant Therapy;
Androgen Antagonists/therapeutic use*;
Prospective Studies
- From:
Frontiers of Medicine
2023;17(2):231-239
- CountryChina
- Language:English
-
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.
