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Knowledge about the impact of radiotherapy (RT) on patient’s quality of life (QoL) is mandatory to improve future treatments. For this purpose, Common Terminology Criteria for Adverse Events (CTCAE) and Patient Reported Outcome Measures (PROMs) are often used in clinical trials. However, there is also a need for knowledge regarding patients QoL after modern conventional RT especially if this has not been investigated through PROMs earlier. Therefore, we conducted a prospective and longitudinal collection of CTCAE and PROMs for patients receiving standard RT for prostate cancer in our clinic.

In 2015 one radiotherapy nurse, two oncologists and two physicists designed a protocol for prospective registration of adverse effects following either curative RT for T1-T3N0M0 prostate cancer, or salvage RT for biochemical recurrence after radical prostatectomy. The scope was to gather information based on validated questionnaires regarding AE. Hence, CTCAE v4.0 (26 items like diarrhea and rectal bleeding), the Expanded Prostate Cancer Index Composite (EPIC), EORTC QLQ-C30 and a segment of EORTC QLQ-PR25 were set up.

The infrastructure was ready for inclusion by October 2017. Oncologists provided patient characteristics (weight, smoking status, tumor classification etc.). At the consultations, CTCAE scores were initially recorded on paper but as staff became more experienced, direct database entry was practiced. The electronic collection of PROMs was done in SurveyXact (Rambøll): The database was programmed to send out links to the patient’s digital mailbox (supplied by the Danish authorities) at predefined dates counting from the last day of RT in advance of each follow-up consultation. The study was observational and clinicians were expected to access the patient’s answers to focus on the most important QoL topics during the consultation.

Depending on residence, patients had full or partial appearances as given in Table 1 and they gave consent to registration of CTCAE and PROMs or CTCAE only. Patient inclusion was planned to run for five years with a five year follow up time.

Enrolment ended in June 2022. Enrolment rate was high, with 403 patients out of 426 eligible patients included. A database audit in 2019 showed a drop in data quality in especially baseline data collection for both CTCAE and PROMs. Table 2 shows the number of patients enrolled and the response rates (RR). The observed RR are higher than the 42%±8.7% reported by Wang et al. for electronic-only format [1].

Throughout the inclusion, dedicated human resources are highly recommended for high enrolment, baselines and RR. Regular data base audits and communication of project status to involved staff is crucial. Patients are likely to participate and high RR are seen for electronic survey responses. Causality between RT parameters and adverse effects will be studied concurrently as the follow-up data matures.

[1] Wang K, et al. BMJ Open 2020;10:e030808.