NCT04228211 Utrecht Prostate Cohort for Cancer Treatment Intervention Studies and Long-term Evaluation
| NCT ID | NCT04228211 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UMC Utrecht |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2020-02-05 |
| Primary Completion | 2030-02-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2020-02-05 with a primary completion date of 2030-02-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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.
Contact & Investigator
Helena M. Verkooijen, MD, PhD
PRINCIPAL INVESTIGATOR
UMC Utrecht
Frequently Asked Questions
Who can join the NCT04228211 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04228211 currently recruiting?
Yes, NCT04228211 is actively recruiting participants. Contact the research team at f.r.teunissen@umcutrecht.nl for enrollment information.
Where is the NCT04228211 trial being conducted?
This trial is being conducted at Nieuwegein, Netherlands, Utrecht, Netherlands.
Who is sponsoring the NCT04228211 clinical trial?
NCT04228211 is sponsored by UMC Utrecht. The principal investigator is Helena M. Verkooijen, MD, PhD at UMC Utrecht. The trial plans to enroll 1,500 participants.
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