Cohort for prostate cancer treatment evaluation and long-term outcomes
Utrecht Prostate Cohort for Cancer Treatment Intervention Studies and Long-term Evaluation
This study is gathering information from men newly diagnosed with prostate cancer to see how different treatments work and how they affect patients over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | UMC Utrecht Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Nieuwegein, Utrecht and 1 other locations) |
| Trial ID | NCT04228211 on ClinicalTrials.gov |
What this trial studies
The Utrecht Prostate Cohort aims to create a comprehensive observational database for patients with newly diagnosed prostate cancer. This cohort will facilitate multiple randomized controlled trials to evaluate new treatment interventions while also assessing short- and long-term clinical and patient-reported outcomes. Utilizing the Trials within Cohorts (TwiCs) design, the study will allow for simultaneous evaluation of various interventions within a large prospective cohort. The participating centers include the University Medical Center Utrecht and St. Antonius Hospital Nieuwegein, both of which provide a full spectrum of prostate cancer care.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with newly diagnosed histologically proven prostate cancer.
Not a fit: Patients who are mentally incompetent or unable to understand the Dutch language may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and quality of life for patients with prostate cancer.
How similar studies have performed: Other studies utilizing the TwiCs design have shown promise in evaluating treatment interventions, suggesting this approach is both innovative and tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Mentally incompetent patients. * Inability to understand the Dutch language.
Where this trial is running
Nieuwegein, Utrecht and 1 other locations
- St. Antonius Hospital — Nieuwegein, Utrecht, Netherlands (Recruiting)
- University Medical Center Utrecht — Utrecht, Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Helena M. Verkooijen, MD, PhD — UMC Utrecht
- Study coordinator: Frederik R. Teunissen, MD
- Email: f.r.teunissen@umcutrecht.nl
- Phone: +31 (0)887567692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.