A Phase 2 Trial of Radium²²³ and Stereotactic Ablative Radiotherapy in Hormone-Naïve Men with Oligometastatic Prostate Cancer to Bone: The RadSABR study.

IF 6.4 1区医学 Q1 ONCOLOGY

International Journal of Radiation Oncology Biology Physics Pub Date : 2025-02-06 DOI:10.1016/j.ijrobp.2025.01.025

Jonathan Tward, Shane Lloyd, Skyler Johnson, Christopher Dechet, Brock O Nei, Benjamin Maughan, Umang Swami, Sumati Gupta, Alejandro Sanchez, Kristine Kokeny, Neeraj Agarwal

{"title":"A Phase 2 Trial of Radium223 and Stereotactic Ablative Radiotherapy in Hormone-Naïve Men with Oligometastatic Prostate Cancer to Bone: The RadSABR study.","authors":"Jonathan Tward, Shane Lloyd, Skyler Johnson, Christopher Dechet, Brock O Nei, Benjamin Maughan, Umang Swami, Sumati Gupta, Alejandro Sanchez, Kristine Kokeny, Neeraj Agarwal","doi":"10.1016/j.ijrobp.2025.01.025","DOIUrl":null,"url":null,"abstract":"Purpose: We hypothesized that treatment with Radium223 (Ra223) and Stereotactic Ablative Radiotherapy (SABR) in patients with bone-only metachronous oligometastastic hormone-sensitive prostate cancer (moHSPC) could safely delay the start of androgen deprivation therapy (ADT) and maintain quality of life (QoL).Methods: This prospective trial included twenty men with moHSPC and ≤5 bone-only metastases who previously had definitive treatment to the prostate and pelvic lymph nodes. Eligibility criteria were testosterone ≥ 100 ng/dL and metastases validated by conventional imaging. Exclusion criteria were post-initial treatment LHRH therapy or N1 disease at bone metastasis diagnosis. Treatment included six cycles of Ra223 and SBRT (30 Gy in five fractions). Bone scans and PSA levels were monitored regularly. The primary endpoint was freedom from ADT (FFAdt) use at 15 months in ≥20% of patients. Patients were followed for 2 years, with clinically significant PRO changes defined as >1/2 standard deviation from baseline. Statistical analyses used Wilcoxon rank sum, Pearson's Chi2 tests, and univariate Cox regression, with significance set at P<0.05 RESULTS: The median number of Ra223 cycles was six. FFAdt at 15 and 24 months was 50.0% and 40.0%, respectively (p<0.001). Eleven (55%) and five (25%) patients had PSA declines exceeding 50% and 90%, respectively, with two patients achieving undetectable PSA levels (<0.01) at two years. No significant changes were observed in any PRO QoL domains. Two patients had grade 3 SREs, and grade 2+ events attributed to Ra223 and EBRT were observed in four and two patients, respectively.Conclusions: In this phase II trial, the initial use of Ra223 and SABR for moHSPC significantly delayed ADT use compared to historical controls. The therapy is well tolerated, preserves QoL, and can lead to undetectable PSA levels at two years.","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":" ","pages":""},"PeriodicalIF":6.4000,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Radiation Oncology Biology Physics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.ijrobp.2025.01.025","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Purpose: We hypothesized that treatment with Radium²²³ (Ra²²³) and Stereotactic Ablative Radiotherapy (SABR) in patients with bone-only metachronous oligometastastic hormone-sensitive prostate cancer (moHSPC) could safely delay the start of androgen deprivation therapy (ADT) and maintain quality of life (QoL).

Methods: This prospective trial included twenty men with moHSPC and ≤5 bone-only metastases who previously had definitive treatment to the prostate and pelvic lymph nodes. Eligibility criteria were testosterone ≥ 100 ng/dL and metastases validated by conventional imaging. Exclusion criteria were post-initial treatment LHRH therapy or N1 disease at bone metastasis diagnosis. Treatment included six cycles of Ra²²³ and SBRT (30 Gy in five fractions). Bone scans and PSA levels were monitored regularly. The primary endpoint was freedom from ADT (FFAdt) use at 15 months in ≥20% of patients. Patients were followed for 2 years, with clinically significant PRO changes defined as >1/2 standard deviation from baseline. Statistical analyses used Wilcoxon rank sum, Pearson's Chi2 tests, and univariate Cox regression, with significance set at P<0.05 RESULTS: The median number of Ra²²³ cycles was six. FFAdt at 15 and 24 months was 50.0% and 40.0%, respectively (p<0.001). Eleven (55%) and five (25%) patients had PSA declines exceeding 50% and 90%, respectively, with two patients achieving undetectable PSA levels (<0.01) at two years. No significant changes were observed in any PRO QoL domains. Two patients had grade 3 SREs, and grade 2+ events attributed to Ra²²³ and EBRT were observed in four and two patients, respectively.

Conclusions: In this phase II trial, the initial use of Ra²²³ and SABR for moHSPC significantly delayed ADT use compared to historical controls. The therapy is well tolerated, preserves QoL, and can lead to undetectable PSA levels at two years.

查看原文本刊更多论文

求助全文

约1分钟内获得全文求助全文

来源期刊

International Journal of Radiation Oncology Biology Physics 医学-核医学

CiteScore

11.00

自引率

7.10%

发文量

2538

审稿时长

6.6 weeks

期刊介绍： International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field. This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.