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Background and purpose:The phase II PROSEVEN (MR-guided prostate stereotactic body radiotherapy in seven days) evaluated acute genitourinary (GU) and gastrointestinal (GI) toxicity following stereotactic body radiotherapy (SBRT) for prostate cancer (Pca). The treatment involved delivering 36Gy in five fractions to the planning target volume (PTV), 40Gy to the clinical target volume (CTV), and a simultaneous integrated boost (SIB) to the intraprostatic tumor (GTV) up to 42Gy, using MR-guided radiotherapy (MRgRT) with a 0.35-T MR Linac over seven days.
Materials and methods:The primary endpoint was the incidence of clinician-reported acute GU and GI toxicity of grade 2 or higher, assessed using CTCAE v5.0. Secondary endpoints included patient-reported outcomes (PROMs), biochemical failure, disease-free survival, and overall survival. This phase II Proseven trial, approved by the Ethics Committee of UZ Brussels, has completed recruitment with five-year follow-up ongoing.
Results:A total of 132 patients with low (12.1%), intermediate (66.6%), and limited high-risk (21.2%) Pca were included. The median PSA at diagnosis was 9.43 ng/ml. SIB to the GTV was performed in 82.6% of patients, and 64.4% completed the treatment within the specified 7 days OTT. Grade 2+ GU toxicity occurred in 35% (of which 1.5% grade 3). Grade 2+ GI toxicity occurred in 5%. No grade 3 GI toxicity was observed.
Conclusion:Prostate SBRT with SIB to the GTV in seven days using MRgRT demonstrated acceptable acute GU toxicity rates and low acute GI toxicity.
Materials and methods:The primary endpoint was the incidence of clinician-reported acute GU and GI toxicity of grade 2 or higher, assessed using CTCAE v5.0. Secondary endpoints included patient-reported outcomes (PROMs), biochemical failure, disease-free survival, and overall survival. This phase II Proseven trial, approved by the Ethics Committee of UZ Brussels, has completed recruitment with five-year follow-up ongoing.
Results:A total of 132 patients with low (12.1%), intermediate (66.6%), and limited high-risk (21.2%) Pca were included. The median PSA at diagnosis was 9.43 ng/ml. SIB to the GTV was performed in 82.6% of patients, and 64.4% completed the treatment within the specified 7 days OTT. Grade 2+ GU toxicity occurred in 35% (of which 1.5% grade 3). Grade 2+ GI toxicity occurred in 5%. No grade 3 GI toxicity was observed.
Conclusion:Prostate SBRT with SIB to the GTV in seven days using MRgRT demonstrated acceptable acute GU toxicity rates and low acute GI toxicity.
| Originele taal-2 | English |
|---|---|
| Aantal pagina's | 16 |
| DOI's | |
| Status | Published - 8 apr. 2025 |
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