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

doi:10.1007/s11684-022-0939-9

Front. Med.

2023, Vol. 17

Issue (2) : 231-239 https://doi.org/10.1007/s11684-022-0939-9

RESEARCH ARTICLE

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

Yifan Chang¹, Xianzhi Zhao², Yutian Xiao¹, Shi Yan¹, Weidong Xu³, Ye Wang¹, Huojun Zhang²(

), Shancheng Ren³(

)

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

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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

Corresponding Author(s): Huojun Zhang,Shancheng Ren

Just Accepted Date: 21 November 2022 Online First Date: 27 December 2022 Issue Date: 26 May 2023

Cite this article:

Yifan Chang,Xianzhi Zhao,Yutian Xiao, et al. 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[J]. Front. Med., 2023, 17(2): 231-239.

URL:

https://academic.hep.com.cn/fmd/EN/10.1007/s11684-022-0939-9
https://academic.hep.com.cn/fmd/EN/Y2023/V17/I2/231

Tab.1 Patient demographics, clinical stage and perioperative data in each individual patient

Tab.2 Postoperative PSA, follow-up treatment, and treatment-induced toxicities in each individual patient.

Fig.1 Radiological manifestation on consecutive images during the treatment course, showing reduction of lesion size or contrast uptake, as well as histological tumor regression on prostate biopsy vs prostatectomy specimen. (A) Prostatic fossa before naADT; (B) prostatic fossa before naRT; (C) prostatic fossa after naRT; (D) prostatic fossa 1 year after RP; (E) left iliac lymph node before naADT; (F) left iliac lymph node before naRT; (G) left iliac lymph node after naRT; (H) left iliac lymph node 1 year after RP; (I) left S3 bone metastasis before naADT; (J) left S3 bone metastasis before naRT; (K) left S3 bone metastasis after naRT; (L) left S3 bone metastasis 1 year after RP (right); (M) histopathological changes in prostatic biopsy, showing adenocarcinoma; (N) pathology of the same patient after prostatectomy, showing tumor regression grade I (MD Anderson) with no viable tumor cells after neoadjuvant treatment. PSMA, prostate-specific membrane antigen; wbMRI, whole-body magnetic resonance imaging; naADT, neoadjuvant androgen deprivation therapy; naRT, neoadjuvant radiotherapy; RP, radical prostatectomy.

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