To facilitate the performance and ensure high quality of clinical trials and research the EUOG and CHDR have formed a consortium which has uniform legal and financial boundaries and shares a set of standard operating procedures (SOPs), clinical trial management and pharmacovigilance. The consortium has agreements with regard to business development and aims to execute a number of sponsored projects on an annual basis. Financial benefits will be invested in trial nurses and fellow PhD fellows with thesis topics related to activities of the EUOG. Trained staff of the CHDR as well as operating management systems and databases to guarantee an efficient business execution are shared with the EUOG.
Clinical trials are research studies in which doctors try to find the answers to important patient care issues and new ways to improve health and cancer care. Each individual study aims to answer specific scientific questions and to find better ways to diagnose or treat cancer. In all trials, clinical data are collected in a systematic way to obtain all the necessary information. Clinical trials may incur considerable costs. By participating in clinical trials patients help doctors to find the answer to important questions to ultimately improve cancer care.
Muscle Invasive Bladder Cancer Trial
The clinical trial “18F-FDG PET/CT versus conventional imaging in staging or primary muscle invasive bladder cancer” has recently been started -first patients have been included- and soon become running in seven countries. This study initiated by the European Uro-Oncology Group will test the predictive accuracy of 18F-FDG PET/CT in comparison to conventional work-up with contemporary CT scan for the preoperative detection of nodal and distant metastases in patients with invasive T2-T3 bladder cancer through detailed comparison of CT imaging and pathologic findings following radical cystectomy.
Trials in Metastatic Prostate Cancer
- Study of Oral Enzalutamide (XTANDI) Androgen Receptor (AR)-Directed Therapy in Hormono-Sensitive patients with Metastatic Prostate Cancer
- Study of Oral Enzalutamide (XTANDI) Androgen Receptor (AR)-Directed Therapy in Chemo-Naïve patients with Progressive Prostate Cancer who have failed Androgen Deprivation Therapy (CRPC patients)
Exploratory first-in-man study to investigate the pharmacokinetics and safety of liposomal dexamethasone at a 2- and 1-week interval in patients with metastatic castration resistant prostate cancer (mCRPC)
In this exploratory first‐in‐man prospective study, mCRPC patients in part A received a starting dose of 10 mg followed by five doses of 20 mg liposomal dexamethasone at 2‐week intervals. Upon review of part A safety, patients in part B received 10 weekly doses of 18.5 mg. Primary outcomes were safety and pharmacokinetic profile, secondary outcome was antitumor efficacy.
The end‐stage CRPC patients had received multiple lines of treatment prior to enrolment.
This exploratory clinical study focussed on safety and PK, and was not powered, nor set‐up to assess antitumor efficacy of liposomal dexamethasone.
IV administration of liposomal dexamethasone was well‐tolerated.
In one patient, a biochemical response was measured.
The safety‐ and pharmacokinetic profile of weekly IV administered liposomal dexamethasone support further trials to investigate the targeting and efficacy of liposomal dexamethasone in well‐powered experiments, and the possibility of combination with other anticancer agents.
Ongoing Trial ‘Upper Tract Urothelial Cancer’
“Neo-adjuvant versus Adjuvant chemotherapy in Upper Tract Urothelial Carcinoma: A feasibility phase II randomized clinical trial (“URANUS”)” . Centres in Europe and Japan participate in this clinical trial.
Steering Committee and Data Monitoring Board
Susanne Osanto (coordinating investigator) Leiden (NL)
Wolfgang Loidl Linz (AT)
Igle-Jan de Jong Groningen (NL)
Manfred Wirth Dresden (DE)
Christophe Deroose Leuven (BE)
Jan Pruim Groningen (NL)
Jörg Kotzerke Dresden (DE)
Ferran Algaba Barcelona (ES)