Study design
malignancy, infections, skin cancers, tumour
CHRONIC ILLNESSES, INFECTIONS, RECRUITMENT, METASTATIC DISEASE, SKIN CANCERS, TUMOUR, PROSTATE ADENOCARCINOMA, CARCINOMA IN SITU, METASTATIC PROSTATE CANCER
The ExPeCT trial was an international multi-centre two-armed randomised controlled trial (RCT). Men living with metastatic prostate cancer were randomly assigned to either a 6-month aerobic exercise programme or to the control arm. Patients were recruited between October 2014 and until study completion in March 2017.The study protocol has been described previously (9). In summary, eligibility criteria included the folowing: (1) patients aged ≥ 18 years and male, (2) histologically confirmed diagnosis of prostate adenocarcinoma, (3) M1 metastatic disease as confirmed by computed tomography (CT)/magnetic resonance imaging (MRI) or by bone scan, excluding patients who only had nodal metastatic disease, (4) stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 28 days prior to randomisation, (5) capable of participating safely in the proposed exercise as assessed and signed off by a treating physician involved in ExPeCT recruitment. Exclusion criteria included the following: (1) patients with a history of radical prostatectomy, (2) patients with other known malignancy (except non-melanoma skin cancers or fully excised carcinoma in situ at any site).Participants were enrolled by appropriate staff at the medical oncology clinics at each of the six recruiting sites in Dublin, Ireland, and London, UK. Written informed consent was obtained by clinic staff or a member of the ExPeCT research team according to the requirements of the International Conference on Harmonisation—Good Clinical Practice. Randomisation was based on a computer-generated algorithm held and controlled by an independent gatekeeper to conceal allocation. Sample size was calculated based on the primary outcome of circulating tumour cells [