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

NCT04228211 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2026-03-05

No results posted yet for this study

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).

Conditions

Sponsors & Collaborators

  • St. Antonius Hospital

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Helena M. Verkooijen, MD, PhD · UMC Utrecht

  • Jochem R.N. van der Voort van Zyp, MD, PhD · UMC Utrecht

  • Harm H.E. van Melick, MD, PhD · St. Antonius Hospital

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-05
Primary Completion
2030-02-05
Completion
2033-02-05

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04228211 on ClinicalTrials.gov