Utrecht Prostate Cohort for Cancer Treatment Intervention Studies and Long-term Evaluation
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorUMC Utrecht
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Mentally incompetent patients.
Inability to understand the Dutch language.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Change from baseline Quality of Life
Assesment of Health-related quality of life in prostate cancer patients undergoing treatment
Time frame
Up to 10 years after treatment2
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.
Time frame
Up to 10 years after treatment3
Occurence of disease recurrence/progression
Biochemical prostate specifice antigen (PSA) recurrence/progression and recurrence/progression based on medical imaging
Time frame
Up to 10 years after treatmentSecondary 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).
Time frame
Up to 10 years after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
UMC Utrecht
Lead sponsor
St. Antonius Hospital
Collaborator
Source ClinicalTrials.gov