Prostate CancerUPCNCT04228211
Utrecht Prostate Cohort for Cancer Treatment Intervention Studies and Long-term Evaluation
An observational study of Prostate Cancer, run by UMC Utrecht at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 1,500 participants
- Where
- 2 sitesNetherlands
- Study dates
- 5 Feb 2020to 5 Feb 2033
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: All 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 will be eligible to be enrolled in the cohort.
Who may be able to join
- 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.
Who cannot join
- Mentally incompetent patients.
- Inability to understand the Dutch language.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
St. Antonius Hospital
Nieuwegein, Utrecht, 3435CM
Harm H.E. van Melick, MD, PhD, +31 (0)883203000, h.van.melick@antoniusziekenhuis.nl
Harm H.E. van Melick, MD, PhD
- Recruiting
University Medical Center Utrecht
Utrecht, Utrecht, 3508GA
Frederik R. Teunissen, MD, +31 (0)887567692, f.r.teunissen@umcutrecht.nl
Helena M. Verkooijen, MD, PhD, +31 (0)887556689, h.m.verkooijen@umcutrecht.nl
About this study
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.
Read more
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).
Read the detailed description
Introduction to Trials within Cohorts (TwiCs) design:
With "Utrecht Prostate Cohort for cancer treatment intervention studies and long term evaluation"(UPC) the investigators aim to: (1) develop an ongoing observational database with short- and long-term clinical and patient-reported outcomes during and after treatment for newly diagnosed prostate cancer. (2) Provide a cohort for multiple randomized controlled trials for evaluation of new treatment interventions for prostate cancer. The initial collaborating centers in the UPC study are the University Medical Center (UMC) Utrecht and the St. Antonius Hospital Nieuwegein both regional tertiary referral centers, covering the total spectrum of prostate cancer care. All patients with newly diagnosed histologically proven prostate cancer presenting at the UMC Utrecht or the St. Antonius Hospital Nieuwegein are eligible for participation in UPC.
The investigators will implement a cohort-based trial infrastructure following the TwiCs design. The TwiCs design is an efficient alternative to the classic randomized controlled trial (RCT) and is considered particularly suitable for evaluation of image guided interventions. In TwiCs, prospective cohorts or registries serve as facilities for simultaneous and randomised evaluation of multiple interventions for the same condition. The basis of the TwiCs is a large prospective observational cohort of patients with the condition of interest (e.g. prostate cancer), who (in principle) undergo standard treatment and for whom relevant short and long term outcome measures are captured. For each new intervention, all eligible patients within the cohort are identified. Some of these eligible patients will be randomly selected and offered the new intervention. The outcomes of these randomly selected patients are then compared to those of the eligible patients receiving usual care. The same process can be repeated (simultaneously) for other experimental interventions. Advantages of the TwiCs are its ability to facilitate multiple randomised evaluations, the improved comparability between trials and the patient-centred informed consent procedure. Higher numbers of eligible patients are expected to be enrolled in studies, improving generalisability of results. Also, the cohorts can serve as patient pools from which patients can be selected for the R-IDEAL (Radiotherapy-Idea, Development, Exploration, Assessment, and Long-term evaluation) stage 2a technical development studies, and as registries for long term follow-up studies.
In the Utrecht region, the investigators have set up multiple cohorts according to the TwiCs design, in which over 4000 patients have been enrolled, and in which four trials and dozens of technical development and observational studies are running.
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, trials within cohorts (TwiCs) design
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Quality of Life
Assesment of Health-related quality of life in prostate cancer patients undergoing treatment
Measured: Up to 10 years after treatment
Occurence of toxicity (adverse events)
All toxicity occurring during or after treatment will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE version 5) and Clavien Dindo classification, for radiotherapy and surgery respectively.
Measured: Up to 10 years after treatment
Occurence of disease recurrence/progression
Biochemical prostate specifice antigen (PSA) recurrence/progression and recurrence/progression based on medical imaging
Measured: Up to 10 years after treatment
Secondary outcomes (1)
Survival
Survival of participating patients will be recorded using the follow up questionnaires (returned by family members) or are derived from the Municipal Personal Records Database (in Dutch: Gemeentelijke Basisadministratie, GBA).
Measured: Up to 10 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start5 Feb 2020
- Primary completion5 Feb 2030 (estimated)
- Study completion5 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- St. Antonius Hospital
- Responsible party
- Principal investigator, Helena M Verkooijen, UMC Utrecht
- Investigators
- Helena M. Verkooijen, MD, PhD, Principal investigator, UMC UtrechtJochem R.N. van der Voort van Zyp, MD, PhD, Principal investigator, UMC UtrechtHarm H.E. van Melick, MD, PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228211
- Sponsor's protocol ID
- NL70198.041.19
- Acronym
- UPC
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2020
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Teunissen FR, Willigenburg T, Meijer RP, van Melick HHE, Verkooijen HM, van der Voort van Zyp JRN. The first patient-reported outcomes from the Utrecht Prostate Cohort (UPC): the first platform facilitating 'trials within cohorts' (TwiCs) for the evaluation of interventions for prostate cancer. World J Urol. 2022 Sep;40(9):2205-2212. doi: 10.1007/s00345-022-04092-2. Epub 2022 Jul 21.
PubMed 35861861
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utrecht Prostate Cohort for Cancer Treatment Intervention Studies and Long-term Evaluation
- ClinicalTrials.gov ID
- NCT04228211
- Acronym / sponsor ID
- UPC / NL70198.041.19
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, trials within cohorts (TwiCs) design
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- St. Antonius Hospital
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 5 Feb 2030 (estimated)
- Study completion
- 5 Feb 2033 (estimated)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Introduction to Trials within Cohorts (TwiCs) design:
With "Utrecht Prostate Cohort for cancer treatment intervention studies and long term evaluation"(UPC) the investigators aim to: (1) develop an ongoing observational database with short- and long-term clinical and patient-reported outcomes during and after treatment for newly diagnosed prostate cancer. (2) Provide a cohort for multiple randomized controlled trials for evaluation of new treatment interventions for prostate cancer. The initial collaborating centers in the UPC study are the University Medical Center (UMC) Utrecht and the St. Antonius Hospital Nieuwegein both regional tertiary referral centers, covering the total spectrum of prostate cancer care. All patients with newly diagnosed histologically proven prostate cancer presenting at the UMC Utrecht or the St. Antonius Hospital Nieuwegein are eligible for participation in UPC.
The investigators will implement a cohort-based trial infrastructure following the TwiCs design. The TwiCs design is an efficient alternative to the classic randomized controlled trial (RCT) and is considered particularly suitable for evaluation of image guided interventions. In TwiCs, prospective cohorts or registries serve as facilities for simultaneous and randomised evaluation of multiple interventions for the same condition. The basis of the TwiCs is a large prospective observational cohort of patients with the condition of interest (e.g. prostate cancer), who (in principle) undergo standard treatment and for whom relevant short and long term outcome measures are captured. For each new intervention, all eligible patients within the cohort are identified. Some of these eligible patients will be randomly selected and offered the new intervention. The outcomes of these randomly selected patients are then compared to those of the eligible patients receiving usual care. The same process can be repeated (simultaneously) for other experimental interventions. Advantages of the TwiCs are its ability to facilitate multiple randomised evaluations, the improved comparability between trials and the patient-centred informed consent procedure. Higher numbers of eligible patients are expected to be enrolled in studies, improving generalisability of results. Also, the cohorts can serve as patient pools from which patients can be selected for the R-IDEAL (Radiotherapy-Idea, Development, Exploration, Assessment, and Long-term evaluation) stage 2a technical development studies, and as registries for long term follow-up studies.
In the Utrecht region, the investigators have set up multiple cohorts according to the TwiCs design, in which over 4000 patients have been enrolled, and in which four trials and dozens of technical development and observational studies are running.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All 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 will be eligible to be enrolled in the cohort.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Mentally incompetent patients.
- Inability to understand the Dutch language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline Quality of Life
Time frame: Up to 10 years after treatment
Assesment of Health-related quality of life in prostate cancer patients undergoing treatment
Occurence of toxicity (adverse events)
Time frame: Up to 10 years after treatment
All toxicity occurring during or after treatment will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE version 5) and Clavien Dindo classification, for radiotherapy and surgery respectively.
Occurence of disease recurrence/progression
Time frame: Up to 10 years after treatment
Biochemical prostate specifice antigen (PSA) recurrence/progression and recurrence/progression based on medical imaging
1 secondary outcome
Survival
Time frame: Up to 10 years after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Derived from this study: PubMed 35861861Teunissen FR, Willigenburg T, Meijer RP, van Melick HHE, Verkooijen HM, van der Voort van Zyp JRN. The first patient-reported outcomes from the Utrecht Prostate Cohort (UPC): the first platform facilitating 'trials within cohorts' (TwiCs) for the evaluation of interventions for prostate cancer. World J Urol. 2022 Sep;40(9):2205-2212. doi: 10.1007/s00345-022-04092-2. Epub 2022 Jul 21.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helena M. Verkooijen, MD, PhD principal investigator
UMC Utrecht
Jochem R.N. van der Voort van Zyp, MD, PhD principal investigator
UMC Utrecht
Harm H.E. van Melick, MD, PhD principal investigator
St. Antonius Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by UMC Utrecht at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederik R. Teunissen, MD (+31 (0)887567692, f.r.teunissen@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Quality of Life (time frame: Up to 10 years after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04228211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.