Table 2.
SABR-COMET-3 Follow-up Evaluation and Assessment of Efficac
| Assessment | Screening Baseline | Enrollment (Day 0) | Treatment Visit 2 (Day 14) | Follow-up visit | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6 W | 3 M | 6 M (±6 W) | 12 M (±6 W) | 18 M (±6 W) | 24 M (±6 W) | 36 M (±6 W) | 48 M (±6 W) | 60 M* (±6 W) | ||||
| Informed Consent | X | |||||||||||
| Inclusion/Exclusion | X | |||||||||||
| Medical History | X | |||||||||||
| Physical Exam | X | |||||||||||
| **CT scans | X | |||||||||||
| ***Bone Scan or PET | X | Opt | Opt | Opt | Opt | Opt | Opt | Opt | Opt | |||
| Bloodwork & PFTs as applicable | X | |||||||||||
| Pregnancy Test (Urinalysis) | X | |||||||||||
| Randomization | X | |||||||||||
| Medications | X | X | X | X | X | X | X | X | X | X | ||
| QoL questionnaires | X | X | X | X | X | X | X | X | X | X | ||
| CT Planning | X | |||||||||||
| Quality Assurance | X | |||||||||||
| SABR Treatment | X | |||||||||||
| Toxicity Assessment | X | X | X | X | X | X | X | X | X | |||
| Adverse Events | X | X | X | X | X | X | X | X | X | X | ||
| EQ-5D-5 L | X | X | X | X | X | X | X | X | X | |||
| Resource Utilization (Patient and Provider Reported) | X | X | X | X | X | X | X | X | ||||
Footnotes: W weeks, M Months
*or early termination
**Extra imaging outside of study schedule is allowed per discretion of the study doctor
***Either bone or PET is required. If PET is done, bone scan is not required (or vice versa)
**/***Imaging is optional for prostate cancer patients with PSA < 5