Table 2.
Study calendar
| Procedure | Pre Study | Pre-RT (up to 4 months prior) |
Baseline Pre-SBRT Day 1 |
On Tx SBRT 5 fx |
POST TREATMENT VISITS (+/− 4 weeks)* | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 month (+/− 4 wks) | 3 month (+/− 4 wks) |
6 month (+/− 4 wks) |
9 month (+/− 4 wks) |
12 month (+/− 4 wks) |
18 month (+/− 4 wks) |
24 month (+/− 4 wks) |
Q 6 month × 4 yrs | EOS Or Early Term Visit |
||||||
| 30 M 36 M 42 M |
48 M 54 M 60 M (+/− 4 wks) |
|||||||||||||
| Informed Consent | x | |||||||||||||
| Demographics | x | |||||||||||||
| Medical History | x | |||||||||||||
| SOC Physical Exam | x | x | ||||||||||||
| Toxicity assessments / Quality of Life Questionnaires | x** | x** | x | x | x | x | x | x | x | x | x | |||
| SOC Non-Contrast Pelvic CT scan*** | x | |||||||||||||
| SOC MRI of the Prostate or Pelvis | x | |||||||||||||
| SOC PSA Draw**** | x | x | x | x | x | x | x | x | x | |||||
| Translational saliva collection◦ | x | |||||||||||||
| Record Radiation Therapy - 5 fractions | x | |||||||||||||
* Follow-up visits can be conducted over the telephone, with remote collection of QOL information
**Toxicity and QOL assessment required either at pre-RT OR pre-SBRT, but not at both time points
*** For patients with PSA < 1.0 ng/mL, the treatment planning CT can substitute for a diagnostic CT scan (in this case, the CT simulation should be within 1 month of radiotherapy initiation)
**** These SOC blood samples can be drawn remotely, in the event that the patient is following up outside the UCLA system. In these cases, the lab reports should be provided to the study investigators
◦ Whenever feasible, but may be waived
EOS, end of study; SOC, standard of care