Clinical Trial Unit Urology
The department has a professional unit to conduct clinical trials from phase 0 to III. The biologist-epidemiologist Dr. Jos Frantzen currently leads this unit as, non-medical, member of the Urology staff. Specialised nurses share the position of clinical trial coordinator / research nurse. We have two patient rooms exclusively available on the outpatient department to see patients participating in the study. All equipment is available to perform all kinds of standard assessments of Urology. In addition, we have equipment for general safety assessments like an ECG available. Phase 0 studies are run in collaboration with the department of Nuclear Medicine and PET research. The collaboration between the department of Urology and that of Nuclear Medicine and PET Research is facilitated by the appointment of the biologist Dr. Geldof at both departments.
The clinical trial unit encompasses an own, protected, archive room for temporarily storage of all essential documents. Electronic versions of documents are stored on a protected part of the internal network. The progress of a study is recorded also using the electronic system. We follow Standard Operation Procedures for both, the clinical and administrative parts of a trial. The set of available SOP's provides the basis for both, the safety of patients and a fast conductance of a trial. Appropriate training of the staff involved in combination with the SOP's does indeed guarantee safety and velocity.
Each clinical trial is lead by an urologist assisted by the staff of the Research Office Urology. The Research Office Urology supported about 40 clinical trials since its start in 2005. The areas of interest are, prostate cancer, bladder cancer, overactive bladder, benign prostatic hyperplasia, erectile dysfunction, hypogonadism, bladder pain syndrome, and hydronephrosis. Complementary pre-clinical research is running for prostate cancer and overactive bladder / bladder pain syndrome.
Below you find the patientinformation forms (PIF) of current trials that focus on the prostate:
Below you find the patientinformation forms (PIF) of current trials that focus on functional urology:
1. Prostate cancer
A. To discriminate between indolent, slow growing tumours and aggressive, metastasising cancer there is an urgent need to develop better, prognostic markers for prostate cancer. Therefore one project aims on the development of a marker combination for early detection of high risk prostate cancer. A number of markers is actively screened (project by dr. C. Lemos and from April 1, 2010 onwards by dr. I. Bijnsdorp) using immunohistochemical techniques on archival paraffin tissue.
B. Another project focuses on the prospects and mechanisms of immunotherapy using intratumoral IL2 injection. The therapeutic effects of combining IL2 with other inroads to mount an effective and specific immunity towards prostate cancer is investigated in an in vivo Dunning tumour model (project by dr. JJL Jacobs). Related to this project is the concept of a clinical study involving application of IL2 in bladder cancer patients (by prof. dr. W. den Otter).
C. The exact influence of tissue concentrations of androgenic steroids on prostatic cell biology and clinical behaviour (hyperplasia as well as neoplasia) is the subject of a project using a tandem-MS technique in clinical and experimental tumour samples (project by drs. TM van der Sluis).
2. Bladder function
A. A project aiming at elucidating the distribution and safety of Botulinum injections in the bladder wall is using 125Iodine labelled Botulinum toxin A preparations in an experimental bladder wall model (project by drs. J van Uhm). The functionality of the radiolabeled compound is checked by chromatographic techniques but also by functional ex vivo bladder strip system (together with dept. Nuclear Medicine and with TNO, Rijswijk).
Furthermore the department of Urology actively participates in a number of cooperative research projects together with other VUmc departments like Nuclear Medicine /PET Research (imaging of prostate cancer and therapy effects), Radiotherapy and Medical oncology (radiosensitivity genes in prostate cancer) and with department of Radiology in Utrecht Medical Center (imaging of prostate cancer lymph node metastasis).
The department of Urology works closely together with the following research institutes.
The Cancer Center Amsterdam/ VUmc Institute for Cancer and Immunology (CCA/V-ICI) was set up in 2006 in order to combine all cancer and immunology research activities. This enabled researchers to interact and work together more easily, learn from each other’s knowledge, and it also meant that facilities could be shared. The primary aim of CCA/V-ICI is to coordinate, facilitate and stimulate fundamental, translational and patient-based top-level research. The final aim – detecting cancer and immunological disorders at an early stage – flows from knowledge of the development, characteristics, progress and response to treatment. This will lead to improvements in treatment and optimization of patient care. More information available on CCA/V-ICI- website .
ICaR-VU
The Institute for Cardiovascular Research of the Vrije Universiteit of Amsterdam (ICaR-VU) was founded in 1992 on basis of the Dutch University Education Act (WW) of 1986. In 1992 the Research School of Cardiovascular Diseases Maastricht-Amsterdam (CARMA), consisting of the Cardiovascular Research Institute Maastricht (CARIM) and the ICaR-VU, was formally recognized by the Royal Dutch Academy of Sciences (KNAW). The recognition of the Research School was officially renewed for another period of five years in July 1997, and again in July 2002. Since May 1998 the ICaR-VU formally collaborates with TNO-PG Leiden. All research projects should ultimately contribute to two research themes (Heart & Vessels). The institute stimulates research in these themes and provides quality control of the research projects. More information available on the website of ICaR-VU .
Research institute MOVE is a collaboration between researchers of the Faculty of Human Movement Sciences, VU University Medical Center and ACTA. The goal of MOVE is to understand human movement by conducting excellent scientific research. The underlying goal is to optimize movement of several groups of patients (i.e. patients with osteoporosis, arthrosis, cerebral palsy or a stroke) and of healthy persons (i.e. children, elderly, sportsmen/women and workers). The goals of MOVE are related to healthcare, with the focus on prevention and recovery of injury and disorders of the musculoskeletal system and on optimal recovery of tissue and function. Furthermore, MOVE wants to apply results of research, which are related to prevent injury and other health problems, as well as improve performance, in ergonomics and sports. More informatie available on the MOVE website .