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.