Table 1.
Recruitment/baseline investigation | MR-guided HIFU treatment | Post-HIFU day 1 |
Post-HIFU day 7 |
Post-HIFU day 14 |
Palliative XRT/chemo | Post-HIFU day 30 |
Post-HIFU day 90 |
|
---|---|---|---|---|---|---|---|---|
Physical examination | ✓ | ✓ | ✓ | ✓ | ✓ | soc | ✓ | ✓ |
Blood work | ✓ | soc | ||||||
MRI | ✓ | ✓ | ✓ | soc | ||||
Toxicity/SAE | ✓ | ✓ | ✓ | ✓ | soc | ✓ | ✓ | |
Pain and analgesic form | ✓ | ✓ | ✓ | ✓ | soc | ✓ | ✓ |
Toxicity and SAE consists of anticipated adverse events screening, NCI CTCAE v4.03 toxicity score and SAE evaluating form when adverse events meet SAE criteria. Pain and analgesic: assessment consists of a visual analogue scale (VAS) and HIFU-related pain and analgesic form
soc standard of care, visits and assessments will follow regular institutional practice. XRT radiotherapy treatment, SAE serious adverse experience