| Title: |
Hermes:Randomized Trial of 2-Fraction or 5-Fraction Magnetic Resonance Imaging–Guided Adaptive Prostate Radiation Therapy |
| Authors: |
Cooper,Sian; Westley,Rosalyne L; Biscombe,Katie; Dunlop,Alex; Mitchell,Adam; Oelfke,Uwe; Nill,Simeon; Manning,Georgina; Burnett,Stephanie; Murray,Julia; Wilkins,Anna; Tunariu,Nina; Price,Derek; Adkins,Aidan; Pathmanathan,Angela; Bucinskaite,Greta; Hafeez,Shaista; Parker,Chris; Ratnakumaran,Ragu; Verkooijen, Helena; Alexander,Sophie; Herbert,Trina; Hall,Emma; Tree,Alison C |
| Publication Year: |
2025 |
| Subject Terms: |
Journal Article |
| Description: |
OBJECTIVE: To demonstrate safety and feasibility of 2-fraction stereotactic body radiotherapy (SBRT) for prostate cancer. METHODS: This single centre, non-comparative, phase II/R-IDEAL2b trial randomised 46 patients with intermediate/lower high-risk prostate cancer with visible gross tumour volume (GTV) on multiparametric magnetic resonance imaging (MRI) to receive 36.25Gy in 5 fractions over 10 days or 24Gy in 2 fractions with a GTV boost up to 27Gy over 8 days. All treatment was delivered on an MR-linac with daily adaptive replanning. The primary endpoint was acute grade ≥2 (G2+) genitourinary (GU) toxicity (CTCAEv5). Secondary endpoints include gastrointestinal (GI) toxicity and patient reported outcomes. RESULTS: G2+GU acute toxicity was observed in 6/22 (27.3%; 95% CI (0.11-0.50) of patients in the 2-fraction group and 7/24 (29.2%; 95% CI (0.13-0.50) in the 5-fraction group. There were no grade 3(G3) GU toxicities. G2+ urinary frequency rose from 4.5% (1/22) at week 2 to 13.6% (3/22) at week 4 in 2-fraction SBRT. G2+ urinary frequency peaked earlier in 5-fraction SBRT at 16.7% (4/24) in week 2, falling to 12.5% (3/24) at week 4. At 12 weeks, median EPIC-26 urinary-incontinence score was 85.5, IQR 75-100) for 2-fraction SBRT and 100, IQR 93.8-100) for 5-fraction SBRT. Urinary irritative-obstructive scores were higher at 12 weeks in the 2-fraction group (93.8, IQR 87.5-100) and 87.5, IQR 81.3-93.8 in the 5-fraction group. Peak IPSS score was lower in the 2-fraction group (8, IQR 4-11) and 13.5, IQR 10-17) in the 5-fraction group. G2+ GI acute toxicity occurred in 3/24 (6.8%) after 5-fraction SBRT, but none after 2-fraction SBRT. CONCLUSIONS: Acceptable acute GU toxicity was seen after 2-fraction SBRT. Acute GI toxicity was low. Randomised trials are warranted to explore late toxicity and biochemical control. |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| ISSN: |
0360-3016 |
| Relation: |
https://dspace.library.uu.nl/handle/1874/466266 |
| Availability: |
https://dspace.library.uu.nl/handle/1874/466266 |
| Rights: |
info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.2FDF10C3 |
| Database: |
BASE |