NCT04228211Recruiting
Utrecht Prostate Cohort for Cancer Treatment Intervention Studies and Long-term Evaluation
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1500 (estimated)
- First submitted
- 3 Jan 2020
- Start date
- 5 Feb 2020
- Primary completion date
- 5 Feb 2030
- Lead sponsor
- UMC Utrecht
- Diseases
- Prostate cancer
- NCT number
- NCT04228211
What you commit to
- Study type: Observational
- Planned participants: 1500
- From 5 Feb 2020 to the primary completion date, 5 Feb 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Mentally incompetent patients.
- Inability to understand the Dutch language.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Antonius Hospital Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Recruiting |
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.