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A phase II randomized trial of Observation vs stereotactic ablative RadiatIon for OLigometastatic prostate CancEr (ORIOLE)

Journal of Clinical Oncology Feb 27, 2020

Tran PT, Phillips R, Shi W, et al. - Whether treatment with stereotactic ablative radiation (SABR) would improve oncologic outcomes in men with oligometastatic prostate cancer (OMPC), was investigated in this phase II randomized trial. Participants were men suffering from recurrent hormone-sensitive OMPC (1-3 radiation fields). The patients were randomized 2:1 to SABR or observation. The participants were stratified by primary management (radiotherapy vs surgery), PSA doubling time, and previous androgen deprivation therapy. Among SABR patients and observation patients, the occurrence of progression was reported at six months in 19% and 61%, respectively. An improved median PFS was achieved with SABR. Reduced risk of new lesions at six months was observed as a result of total consolidation of PSMA radiotracer-avid disease. There was no toxicity ≥ grade 3. Overall, SABR for OMPC afforded improved outcomes and was enhanced by total consolidation of disease detected by PSMA-targeted PET. A systemic immune response was induced by SABR. The benefit from SABR may be predicted by baseline immune phenotype and tumor mutation status.
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