To set up a cohort that will serve as a multi-trial platform and facilitate evaluation of new interventional treatment for prostate cancer.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Genitourinary tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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).
Secondary outcome
NA
Background summary
Prostate cancer is the most common cancer in men worldwide. Survival rates are
high due to the typical 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
choices for primary therapy for clinically localized prostate cancer has a
negative impact on cancer-specific quality of life (QOL). New treatments are
being developed. We aim to build a multidisciplinary prostate cancer cohort.
The Trials within Cohorts (TwiCs) design will be conducted and as a prospective
registry for assessment of long-term safety, performance and effectiveness of
innovative treatments of prostate cancer. These treatments can also be compared
to other treatments in a randomized fashion.
Study 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 *cohort multiple
Randomised Controlled Trial* (cmRCT) design.
Study burden and risks
No risk expected for patients participating in the study. The only burden for
participants will be filling out the questionnaires, approximately 30 minutes
each time.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years.
- Patients with non-metastasised 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
Exclusion criteria
- Mentally incompetent patients.
- Inability to understand the Dutch language.
- Radical treatment of prostate cancer.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70198.041.19 |