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. 2024 Jan 30;14(1):e075846. doi: 10.1136/bmjopen-2023-075846

Table 2.

Schedule of assessments

Required investigation Inclusion Treatment 1 month after RT 3 months after RT 6 months after RT Every 6 months till the end of second year after RT, then once per year till 60 months
Within 12 weeks prior to registration Within 2 weeks prior to registration Within 2 weeks prior to registration
Eligibility check x
Signed informed consent x
Record prior history x
Visits
Physical examination x x x x x
Biochemistry (blood samples)*
PSA x x x x x
Testosterone x x x x x
Radiology
PSMA PET x
MRI x
Radiotherapy
Treatment planning x
Record Planning results x
Adverse Events
Baseline toxicity x
Acute toxicity x x x
Late toxicity x x
EORTC QoL questionnaire
QLQ-C30 x x x x x
QLQ-PR25 x x x x x

*Blood samples: The obtained blood samples are used only for PSA and testosterone values. The measurement for this labs is conducted within the local hospital laboratory of each participating centre and the rest samples will be disposed afterwards. No blood will be collected or stored or used for other research purposes within the frame of this trial.

EORTC, European Organisation for Research and Treatment of Cancer; PSA, prostate-specific antigen; PSMA PET, prostate-specific membrane antigen-positron emission tomography; QLQ-C30, Quality of Life Questionnaire Core 30; QoL, quality of life; RT, radiotherapy.