Table 1.
Standard Protocol Items: Recommendations for Interventional Trials 2013 diagram: Para-Aortic Radiotherapy (PART)-trial.
| Timepoint | Study period | ||||||
|
|
|
Enrollment: Screen visit & pre-PART (-t1) | Postallocation | ||||
|
|
|
|
During PART | Follow-up | |||
|
|
|
|
Weekly | Last day | Month 1, 3, 6, 9, 12 | Month 18, 24, 30, 36, 42, 48, 54, 60 | Year 6 up to year 10, yearly |
| Enrollment | |||||||
|
|
Eligibility screen | X |
|
|
|
|
|
|
|
Informed consent | X |
|
|
|
|
|
| Interventions: Elective PART |
|
—a |
|
|
|
|
|
| Assessments | |||||||
|
|
Clinical examination | X |
|
X | X | X | X |
|
|
Laboratory analysisb | X |
|
X | X | X | X |
|
|
Registration of pretreatment gastrointestinal and genitourinary morbiditiesb | X |
|
|
|
|
|
|
|
Registration quality of life using validated questionnaires | X |
|
X | X | X | X |
|
|
Registration of PART-induced toxicity (Common Toxicity Criteria for adverse events)b |
|
X | X | X | X | X |
|
|
Imaging (after discussion at an interdisciplinary tumor board) | X |
|
|
Xc | Xc | Xc |
aElective PART occurs during the whole period—daily instead of weekly, including the last day.
bStandard examinations; laboratory analysis is described in the protocol.
cIn case of prostate-specific antigen relapse or symptoms.