RecruitingNCT04228211

Utrecht Prostate Cohort for Cancer Treatment Intervention Studies and Long-term Evaluation


Sponsor

UMC Utrecht

Enrollment

1,500 participants

Start Date

Feb 5, 2020

Study Type

OBSERVATIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an observational research study following men newly diagnosed with prostate cancer in the Netherlands who are being treated with radiation, surgery, active surveillance (watchful waiting), or other approaches. The goal is to learn more about outcomes and quality of life over time. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with prostate cancer confirmed by a tissue biopsy - You are being referred to a participating hospital in the Netherlands for treatment or monitoring - You are willing to allow use of your routinely collected medical data and fill out questionnaires **You may NOT be eligible if...** - You are mentally unable to give consent - You cannot understand the Dutch language Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands

University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

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NCT04228211


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