Metastasis-directed SBRT for oligometastatic hormone sensitive prostate cancer (METRO): protocol for a prospective randomised phase III trial, NCT04983095
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 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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