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92 Chapter 5 Study population, inclusion criteria and exclusion criteria The DA is developed for the initial treatment decision in early-stage prostate cancer. In order to be eligible to participate in this study, a subject must meet the following inclusion criteria: 1. Patient is diagnosed with low or intermediate risk prostate cancer (EAU/ESTRO criteria) [30]. 2. Patient is eligible for at least two of following treatment options: active surveillance, radical prostatectomy, brachytherapy, external beam radiotherapy. 3. Patient has access to a PC, laptop or tablet with internet connection. Exclusion criteria are: 1. A combination of PSA ≥ 10 and Gleason = 7 (which defines high risk prostate cancer). 2. Cognitive impairment or being too ill at time of the study. 3. Insufficient understanding of the Dutch language to complete questionnaires and understand the DA. Intervention After being diagnosed with prostate cancer, but before a treatment decision has been made, patients in the intervention arm receive access to the online DA. Healthcare providers are instructed to introduce the DA and the study at diagnosis. However, the pragmatic nature of this trial allows hospitals to integrate the introduction of the DA with their standard information provision routines if that follows later due to follow- up diagnostics or an additional consultation with (oncology) nurses. In daily practice, this means that either the urologist or the (oncology) nurse introduces the DA to the patient. To use the DA, patients receive a card from their urologist stating their relevant disease characteristics (PSA, Gleason, and eligible treatment options) and a personal username and password to gain online access to the DA. If a nurse introduces the DA and accompanying access card, the urologist should provide the requested clinical characteristics to the nurse, either by filling in the card or by leaving a note in the patients’ record. The DA offers a stepwise guidance through the decision process. In the first step, general information about prostate cancer is provided. The second step offers the consideration between active surveillance and curative treatment (surgery or radiotherapy). Values clarification statements are presented in this step to elicit a patient’s preference based on three main differences between AS and curative treatment; acceptance of deferring