The Effect of a Structured Strength and Endurance Training Program on Quality of Life, Fitness, Blood Parameters and Survival in Prostate Cancer Patients

This study is a two-arm open-label controlled trial that aims to investigate the effects of combined resistance and aerobic training on quality of life (QoL), body composition, fitness parameters, immunological parameters, and oncological outcomes in patients with prostate cancer (PC). 150 men will be recruited with either localized, locally advanced, or metastatic PC. Patients will be randomly assigned in a 2:1 ratio to either the intervention arm (guided home-based training) or the standard of care (SOC) arm (self-directed or no exercise). Prior to enrollment, participants will provide written informed consent, undergo clinical eligibility confirmation, and complete screening assessments. Owing to the already documented general health benefits of exercise in patients with PC, participants randomized to the SOC arm will be informed about the benefits of exercise as well, and will be motivated to engage in exercise under their own management (self-directed exercise). Changes in physical activity will be monitored in both groups. This study will include a screening phase, a 12-week intervention phase, a post-12-week intervention phase, and a longer-term intervention phase. During the screening phase (maximally 35 days prior to the first training session), participants will undergo assessments to determine their eligibility for the study. This involves evaluating inclusion and exclusion criteria, as well as data collection on demographics and tumor stage. To avoid bias and to ensure equal participation and motivation of participants from both the intervention and the SOC arm in the baseline tests, patient randomization will only take place after the baseline testing. The 12-week intervention phase comprises the initial 12 weeks of a home-based combined resistance and aerobic training protocol for the intervention arm. Training will commence 8 weeks (when medically cleared, a reduction to minimally 4 weeks is possible) after radical prostatectomy (RP) or completion of external-beam radiotherapy (EBRT), or any time for PC patients undergoing systemic treatment. As part of their visit for baseline testing, participants will be familiarized with the online platform incorporating the training program, including the correct execution of the exercises. In addition, the online platform includes demonstration videos of all exercises. The control arm will receive SOC without any exercise prescriptions. Throughout the phase, participants' physical activity will be monitored using regular questionnaires and wearable device data. Efficacy evaluations will be conducted at baseline and after the 12-week intervention phase. The post-12-week intervention phase will follow the 12-week intervention phase and will last for 1 year. Throughout this phase, QoL, oncological outcomes, laboratory parameters, as well as ongoing physical activity will be assessed periodically. The longer-term intervention phase will begin 1 year after completion of the 12-week intervention phase, and will continue until one of the following events occurs: death, loss to follow-up or withdrawal of consent, or end of the study, whichever occurs first. Throughout this phase, oncological outcomes will be assessed periodically. The study population will consist of men diagnosed with localized, locally advanced, or metastatic PC. Participants with localized or locally advanced PC may be enrolled pre- or post- RP, or at any point before, during, or after EBRT. Training will then commence 4-8 weeks after completion of RP or EBRT. Participants with locally advanced, non-metastatic, and metastatic PC under systemic treatment and not undergoing local curatively intended treatment can be enrolled at any time under any treatment. All measurements will be assessed at baseline (maximally 14 days prior to the first training session) and after the 12-week intervention phase. Additionally, laboratory parameters, patient-reported outcome (PRO) assessments, and wearable data assessments will be repeated 3, 6, and 12 months after completion of the 12-week intervention phase.