Metastasis-directed SBRT for oligometastatic hormone sensitive prostate cancer (METRO) : protocol for a prospective randomised phase III trial, NCT04983095
(2026) In BMC Cancer 26(1).- Abstract
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... (More)
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.
(Less)
- author
- organization
- publishing date
- 2026-12
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Hormone sensitive prostate cancer, Oligo-metastatic, Phase III randomised controlled trial, Stereotactic body radiotherapy, Study protocol
- in
- BMC Cancer
- volume
- 26
- issue
- 1
- article number
- 456
- publisher
- BioMed Central (BMC)
- external identifiers
-
- pmid:41882599
- scopus:105035520614
- ISSN
- 1471-2407
- DOI
- 10.1186/s12885-026-15906-6
- language
- English
- LU publication?
- yes
- id
- b3de1695-573f-478a-ac04-98d8a01a6a9d
- date added to LUP
- 2026-05-27 10:56:07
- date last changed
- 2026-09-04 01:10:08
@article{b3de1695-573f-478a-ac04-98d8a01a6a9d,
abstract = {{<p>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.</p>}},
author = {{Söderkvist, Karin and Zia, Maira and Gunnlaugsson, Adalsteinn and Josefsson, Andreas and Aksnessæther, Bjørg and Li, Chunde and Thellenberg-Karlsson, Camilla and Alm, Daniel and Kudrén, David and Lundin, Erik and Moise, Gabriel and Brandell, Jenny Kahlmeter and Kindblom, Jon and Björnlinger, Kirsten and Karlsson, Kristin and Riklund, Katrine and Westin, Martina and Hedman, Mattias and Skorve, Natalie and Wikström, Pernilla and Strandberg, Sara and Jonsson, Joakim}},
issn = {{1471-2407}},
keywords = {{Hormone sensitive prostate cancer; Oligo-metastatic; Phase III randomised controlled trial; Stereotactic body radiotherapy; Study protocol}},
language = {{eng}},
number = {{1}},
publisher = {{BioMed Central (BMC)}},
series = {{BMC Cancer}},
title = {{Metastasis-directed SBRT for oligometastatic hormone sensitive prostate cancer (METRO) : protocol for a prospective randomised phase III trial, NCT04983095}},
url = {{http://dx.doi.org/10.1186/s12885-026-15906-6}},
doi = {{10.1186/s12885-026-15906-6}},
volume = {{26}},
year = {{2026}},
}