Long-term study of men with newly diagnosed prostate cancer
Follows men newly diagnosed with prostate cancer to study treatment safety and quality of life.
Plain-language title generated from the registry record
Registry title: Utrecht Prostate Cohort for Cancer Treatment Intervention Studies and Long-term Evaluation
Key facts
- Where
- Nieuwegein and Utrecht, NetherlandsSee the 2 sites
Where in Netherlands
- St. Antonius HospitalNieuwegein, NetherlandsTaking people
- University Medical Center UtrechtUtrecht, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UMC Utrecht
- Trial code
- NCT04228211
- Record updated
- 5 March 2026
- Original description
Rationale: Prostate cancer is the most common cancer in men worldwide. Survival rates are high due to the typically non-aggressive nature of disease and effective treatments. Radical treatments such as surgery and radiotherapy often cause toxicity and long term side effects. Based on current available literature, the choice for primary therapy for clinically localised prostate cancer has a negative impact on cancer-specific quality of life (QOL). New interventional treatments are being developed. The investigators aim to build a multidisciplinary prostate cancer cohort which will serve as a multi-trial facility for interventional treatment studies. The Trials within Cohorts (TwiCs) design, also known as cohort multiple Randomized Controlled Trial design (cmRCT) will be conducted and as a prospective registry for assessment of long-term safety, performance and effectiveness new treatment interventions.Read full original descriptionShow less
Utrecht Prostate Cohort for Cancer Treatment Intervention Studies and Long-term Evaluation
Rationale: Prostate cancer is the most common cancer in men worldwide. Survival rates are high due to the typically non-aggressive nature of disease and effective treatments. Radical treatments such as surgery and radiotherapy often cause toxicity and long term side effects. Based on current available literature, the choice for primary therapy for clinically localised prostate cancer has a negative impact on cancer-specific quality of life (QOL). New interventional treatments are being developed. The investigators aim to build a multidisciplinary prostate cancer cohort which will serve as a multi-trial facility for interventional treatment studies. The Trials within Cohorts (TwiCs) design, also known as cohort multiple Randomized Controlled Trial design (cmRCT) will be conducted and as a prospective registry for assessment of long-term safety, performance and effectiveness new treatment interventions.
Objective: To set up a cohort that will serve as a multi-trial platform and facilitate evaluation of new interventional treatment for prostate cancer.
Study design: Observational, prospective cohort study, according to the 'Trials within Cohorts' (TwiCs) design.
Study population: All patients with newly diagnosed histologically proven prostate cancer.
Main study parameters/endpoints: Clinical parameters (e.g. co-morbidity, oncological history, symptoms, imaging, technical and treatment data), clinical endpoints (e.g. toxicity, and survival outcomes) and patient reported outcomes (e.g. QOL).
Inclusion: Age ≥ 18 years; Patients with newly diagnosed histologically proven prostate cancer, referred for radiation treatment to the Radiotherapy Department of the UMC Utrecht or for prostatectomy, watchful waiting or active surveillance to the Urology Department of St. Antonius hospital or the Urology Department of the UMC Utrecht; Informed consent - at least - for use of routinely collected clinical data and to fill out questionnaires.
Exclusion: Mentally incompetent patients; Inability to understand the Dutch language.