Prostate CancerProsquareNCT04694924
Prospective Prostate Cancer and Patient-reported Outcomes Registry
An observational study of Prostate Cancer and Adenocarcinoma of the Prostate, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in Belgium.
Trial summary
This study aims to evaluate the use of a digital solution, integrated into the electronic health record, for prospective and structured reporting of clinical and patient-reported outcomes for patients diagnosed with localized or locally advanced prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Adenocarcinoma of the Prostate, Locally Advanced Prostate Carcinoma
- Type of treatment
- Pill or oral medicine
- How many people
- 5,000 participants
- Where
- 4 sitesBelgium
- Study dates
- 1 Oct 2020to Oct 2030
- 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 localized and locally advanced prostate cancer referred to one of the participating sites will be eligible to be enrolled in the cohort.
Who may be able to join
- Pathology confirmed diagnosis of localized or locally advanced prostate cancer
- Being able to speak, read and understand Dutch, French, or English
- Each patient (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he understands the purpose of, and is willing to participate in the study.
Who cannot join
- Patients with prior treatment for prostate malignancies will be excluded.
- Dementia, mental alteration, or psychiatric pathology that can compromise informed consent from the patient and/ or adherence to the protocol and the monitoring of the trial
- Patients who cannot submit themselves to following the protocol for psychological reasons, social, family, or geographical.
- Persons deprived of liberty or under guardianship
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium4 sites, 4 recruiting
- Recruiting
AZ Sint-Jan Brugge
Bruges, West-Vlaanderen, 8000
Pieter Uvin, MD, PhD, 050 45 25 30
- Recruiting
AZ Sint-Blasius
Dendermonde, Oost-Vlaanderen, 9200
Dieter Ost, MD, PhD, 052 25 25 05
- Recruiting
AZ Groeninge Kortrijk
Kortrijk, West-Vlaanderen, 8500
Siska Van Bruwaene, MD, PhD, 056 63 38 00
- Recruiting
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000
Wouter Everaerts, MD, PhD, 016346687, wouter.everaerts@uzleuven.be
Andries Clinckaert, MD
About this study
Official title: Promoting Quality of Care: a Prospective Cohort Study of Localized and Locally Advanced Prostate Cancer Patients
This study aims to evaluate the use of a digital solution, integrated into the electronic health record, for prospective and structured reporting of clinical and patient-reported outcomes for patients diagnosed with localized or locally advanced prostate cancer.
- Conditions
- Prostate Cancer, Adenocarcinoma of the Prostate, Locally Advanced Prostate Carcinoma, Locally Advanced Prostate Adenocarcinoma
- Being tested
- standard of care
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of careOther
No other procedures than those performed during the usual care for prostate cancer patients will be done. No study medication will be provided as part of participation.
Clinical outcomes will be reported via predefined electronic forms, integrated into the electronic health record (EHR). Patient-reported outcomes will be collected electronically.
All treatment decisions will be made at the discretion of the investigator or treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Localized and locally advanced prostate cancer | Localized prostate cancer (cT1a-T2c N0 M0) refers to the clinical condition where cancer is confined to the prostate gland, in the absence of lymph node invasion or metastases. Locally advanced refers to the extension of the tumor beyond the capsule of the prostate (cT3-T4) or the clinical presence of nodal invasion (cN+), without metastases. Receives: Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of systematically reporting a standardized set of predefined clinical parameters
The proportion of patients who are enrolled in the registry over the total localized and locally advanced prostate cancer patients
Measured: up to 10 years after diagnosis
Assessment of systematically collecting a predefined set of patient-reported outcomes
The proportion of patients who completed all questionnaires over the total of questionnaires send.
Measured: up to 10 years after diagnosis
Secondary outcomes (5)
Occurence of disease recurrence/progression
Biochemical prostate specific antigen (PSA) recurrence/progression and recurrence/progression based on medical imaging
Measured: up to 10 years after diagnosis
General quality of life
Assessment of health-related quality of life in prostate cancer patients. Measured by EORTC Quality of Life Questionnaire C30 (QLQ-C30). The EORTC QLQ-C30 is a generic QoL questionnaire designed to cover issues important to all cancer patients
Measured: at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis
Prostate cancer specific quality of life
Measured by Extended Prostate cancer Index Composite 26 (EPIC26). EPIC-26 is a validated instrument that measures the quality of life across 5 disease-specific domains: urinary incontinence, urinary obstruction and irritation, bowel-related symptoms, sexual dysfunction, and hormonal symptoms.
Measured: at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis
Overall Survival (OS)
Overall survival is defined as the time from enrollment to date of death due to any cause.
Measured: up to 10 years after diagnosis
Prostate Cancer (PC)-related Mortality (PM)
PC-related mortality is the death due to prostate cancer.
Measured: up to 10 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Oct 2020
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Sint-Jan AV, General Hospital Groeninge, AZ Sint-Blasius Dendermonde
- Responsible party
- Sponsor
- Investigators
- Wouter Everaerts, MD, PhD, Principal investigator, UZ Leuven / KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694924
- Sponsor's protocol ID
- S63359
- Acronym
- Prosquare
- Status last verified
- May 2024
- First submitted
- 24 Dec 2020
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Quality of Care: a Prospective Cohort Study of Localized and Locally Advanced Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT04694924
- Acronym / sponsor ID
- Prosquare / S63359
- Conditions
- Prostate Cancer, Adenocarcinoma of the Prostate, Locally Advanced Prostate Carcinoma, Locally Advanced Prostate Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- AZ Sint-Jan AV, General Hospital Groeninge, AZ Sint-Blasius Dendermonde
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 5 Jan 2021 (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.
This study aims to evaluate the use of a digital solution, integrated into the electronic health record, for prospective and structured reporting of clinical and patient-reported outcomes for patients diagnosed with localized or locally advanced prostate cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Localized and locally advanced prostate cancer | – | Other: standard of careLocalized prostate cancer (cT1a-T2c N0 M0) refers to the clinical condition where cancer is confined to the prostate gland, in the absence of lymph node invasion or metastases. Locally advanced refers to the extension of the tumor beyond the capsule of the prostate (cT3-T4) or the clinical presence of nodal invasion (cN+), without metastases. |
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 localized and locally advanced prostate cancer referred to one of the participating sites will be eligible to be enrolled in the cohort.
Key inclusion criteria (3 listed)
- Pathology confirmed diagnosis of localized or locally advanced prostate cancer
- Being able to speak, read and understand Dutch, French, or English
- Each patient (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he understands the purpose of, and is willing to participate in the study.
Key exclusion criteria (4 listed)
- Patients with prior treatment for prostate malignancies will be excluded.
- Dementia, mental alteration, or psychiatric pathology that can compromise informed consent from the patient and/ or adherence to the protocol and the monitoring of the trial
- Patients who cannot submit themselves to following the protocol for psychological reasons, social, family, or geographical.
- Persons deprived of liberty or under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard of careNo other procedures than those performed during the usual care for prostate cancer patients will be done. No study medication will be provided as part of participation. Clinical outcomes will be reported via predefined electronic forms, integrated into the electronic health record (EHR). Patient-reported outcomes will be collected electronically. All treatment decisions will be made at the discretion of the investigator or treating physician. | Other | Localized and locally advanced prostate cancer |
Primary outcome
Assessment of systematically reporting a standardized set of predefined clinical parameters
Time frame: up to 10 years after diagnosis
The proportion of patients who are enrolled in the registry over the total localized and locally advanced prostate cancer patients
Assessment of systematically collecting a predefined set of patient-reported outcomes
Time frame: up to 10 years after diagnosis
The proportion of patients who completed all questionnaires over the total of questionnaires send.
5 secondary outcomes
Occurence of disease recurrence/progression
Time frame: up to 10 years after diagnosis
General quality of life
Time frame: at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis
Prostate cancer specific quality of life
Time frame: at diagnosis, 6 months, 1 year, and annually up to 10 years after diagnosis
Overall Survival (OS)
Time frame: up to 10 years after diagnosis
Prostate Cancer (PC)-related Mortality (PM)
Time frame: up to 10 years after diagnosis
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 22 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Wouter Everaerts, MD, PhD principal investigator
UZ Leuven / KU Leuven
4 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 and Adenocarcinoma of the Prostate, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in Belgium.
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 4 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 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. 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 Wouter Everaerts, MD, PhD (+3216346687, wouter.everaerts@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of systematically reporting a standardized set of predefined clinical parameters (time frame: up to 10 years after diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2024.