Actively Recruiting

Age: 18Years +
MALE
NCT04228211

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

Led by UMC Utrecht · Updated on 2026-03-05

1500

Participants Needed

2

Research Sites

678 weeks

Total Duration

On this page

Sponsors

U

UMC Utrecht

Lead Sponsor

S

St. Antonius Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 63 18 years
  • Newly diagnosed histologically proven prostate cancer
  • Referred for radiation treatment at UMC Utrecht or prostatectomy, watchful waiting, or active surveillance at St. Antonius Hospital or UMC Utrecht
  • Provided informed consent for use of clinical data and to complete questionnaires
Not Eligible

You will not qualify if you...

  • Mentally incompetent patients
  • Unable to understand the Dutch language

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands, 3435CM

Actively Recruiting

2

University Medical Center Utrecht

Utrecht, Utrecht, Netherlands, 3508GA

Actively Recruiting

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Research Team

F

Frederik R. Teunissen, MD

CONTACT

H

Helena M. Verkooijen, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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