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Background <p>Metastasis-directed stereotactic body radiotherapy (MD-SBRT) has shown promise in retrospective and phase II studies for oligometastatic hormone-sensitive prostate cancer. However, prospective randomized phase III data—particularly in newly diagnosed cases and in combination with androgen deprivation therapy and next-generation androgen receptor pathway inhibitors—are limited. The METRO trial investigates the addition of MD-SBRT to standard of care in patients with prostate-specific membrane antigen (PSMA) PET/CT-detected oligometastatic disease.</p> Methods <p>METRO is a multicentre, double arm, open-label, phase III randomized trial comparing MD-SBRT plus standard of care versus standard of care alone in patients with one to three PSMA PET/CT-detected distant metastases. The PSMA-RADS scale is used to support inclusion, and only patients with PSMA-RADS 4 or 5 lesions in bone or non-regional lymph nodes are eligible.</p> <p>Standard of care includes time-limited androgen deprivation therapy and/or androgen receptor pathway inhibitor, as well as local radiotherapy to the prostate or prostate bed. Patients are stratified by disease type (synchronous or metachronous) and metastasis location (lymph node/bone). The primary endpoint is biochemical progression-free survival; secondary endpoints include time to castration-resistant prostate cancer, adverse events, and health-related quality of life.</p> <p>The intervention is prescribed either 30&#xa0;Gy in 3 fractions or 40&#xa0;Gy in 5 fractions and delivered by stereotactic treatment principles.</p> Discussion <p>The METRO trial investigates the added value of combining MD-SBRT with time-limited intensified hormonal therapy in both synchronous and metachronous oligometastatic hormone-sensitive prostate cancer staged by PSMA‑PET/CT. The use of the PSMA-RADS scale for inclusion ensures a standardized and reproducible approach for patient selection.</p> Trial registration <p>ClinicalTrials.gov Identifier: NCT04983095.</p>

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Metastasis-directed SBRT for oligometastatic hormone sensitive prostate cancer (METRO): protocol for a prospective randomised phase III trial, NCT04983095

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月25日

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  • Karin Söderkvist,
  • Maira Zia,
  • Adalsteinn Gunnlaugsson,
  • Andreas Josefsson,
  • Bjørg Aksnessæther,
  • Chunde Li,
  • Camilla Thellenberg-Karlsson,
  • Daniel Alm,
  • David Kudrén,
  • Erik Lundin,
  • Gabriel Moise,
  • Jenny Kahlmeter Brandell,
  • Jon Kindblom,
  • Kirsten Björnlinger,
  • Kristin Karlsson,
  • Katrine Riklund,
  • Martina Westin,
  • Mattias Hedman,
  • Natalie Skorve,
  • Pernilla Wikström,
  • Sara Strandberg,
  • Joakim Jonsson

摘要

Background

Metastasis-directed stereotactic body radiotherapy (MD-SBRT) has shown promise in retrospective and phase II studies for oligometastatic hormone-sensitive prostate cancer. However, prospective randomized phase III data—particularly in newly diagnosed cases and in combination with androgen deprivation therapy and next-generation androgen receptor pathway inhibitors—are limited. The METRO trial investigates the addition of MD-SBRT to standard of care in patients with prostate-specific membrane antigen (PSMA) PET/CT-detected oligometastatic disease.

Methods

METRO is a multicentre, double arm, open-label, phase III randomized trial comparing MD-SBRT plus standard of care versus standard of care alone in patients with one to three PSMA PET/CT-detected distant metastases. The PSMA-RADS scale is used to support inclusion, and only patients with PSMA-RADS 4 or 5 lesions in bone or non-regional lymph nodes are eligible.

Standard of care includes time-limited androgen deprivation therapy and/or androgen receptor pathway inhibitor, as well as local radiotherapy to the prostate or prostate bed. Patients are stratified by disease type (synchronous or metachronous) and metastasis location (lymph node/bone). The primary endpoint is biochemical progression-free survival; secondary endpoints include time to castration-resistant prostate cancer, adverse events, and health-related quality of life.

The intervention is prescribed either 30 Gy in 3 fractions or 40 Gy in 5 fractions and delivered by stereotactic treatment principles.

Discussion

The METRO trial investigates the added value of combining MD-SBRT with time-limited intensified hormonal therapy in both synchronous and metachronous oligometastatic hormone-sensitive prostate cancer staged by PSMA‑PET/CT. The use of the PSMA-RADS scale for inclusion ensures a standardized and reproducible approach for patient selection.

Trial registration

ClinicalTrials.gov Identifier: NCT04983095.