Clinical studies

We offer the latest therapy methods at the study centre. Patients with advanced or very aggressive diseases, for whom the usual treatment methods often fail, are thus given access to promising new therapies.


Why are clinical trials so important?
Tumours of the urogenital tract - including the prostate, urinary bladder, kidney and testicles - account for a large proportion of malignant tumours. Despite often good treatment options, there is a need to establish new therapeutic procedures and/or improve existing treatments. Such therapies aim to prolong survival, alleviate tumour-related symptoms and side effects through treatment, and thus improve the quality of life despite the disease.
Participation in a clinical trial provides access to the latest treatment methods that have not yet been authorised. In addition, the legal regulations for clinical trials require the highest level of safety for the patient and the treating practitioner when carrying out the therapy. Your symptoms and general condition are monitored more intensively and more frequently. This allows early and effective intervention in the event of side effects or a lack of response to the therapy.
It is important to know that you can end your participation in a clinical trial at any time and without giving a reason.
The optimal treatment and care of patients with tumours within and outside of clinical trials can only be guaranteed through close cooperation between general practitioners and the clinic.

Currently recruiting studies can be found below. The most important inclusion and exclusion criteria can be found in the study flyer.

Profilbild von Prof. Dr. med. Friedemann Zengerling, MHBA, FEBU

Prof. Dr. med. Friedemann Zengerling, MHBA, FEBU

Oberarzt, Leitung konservative Uro-Onkologie, Leitung Urologische Studienzentrale

Profilbild von Dr. med. Angelika Mattigk

Dr. med. Angelika Mattigk

Funktionsoberärztin, Stellvertretende Leitung Studienzentrale

Consultation appointments

Phone 0731 500-54777

Fax 0731 500-58165

You can reach us by phone:
Mon to Fri: 08:00 to 16:00

Current clinical studies

You can find more information on this clinical picture here.


SAKK01/18

Radio-chemotherapy with reduced intensity in patients with testicular cancer.

 

IMA401-101

Phase Ia/Ib first-in-human clinical trial to evaluate the safety, tolerability and initial anti-tumour activity of IMA401, a bispecific TCER molecule, in patients with recurrent and/or refractory solid tumours.

You can find more information on this clinical picture here.

TripletRCC (BO 43936):

A randomised, open-label Phase II study of the combination of immune checkpoint inhibitors with axitinib in patients with previously untreated, locally advanced, unresectable or metastatic renal cell carcinoma.

SAMETA:

An open-label, randomised, multicentre, phase III study of savolitinib plus durvalumab versus sunitinib and durvalumab monotherapy in participants with MET-driven, unresectable, locally advanced or metastatic papillary renal cell carcinoma

 

You can find more information on this clinical picture here.

UniCAR02-PSMA-01

Multicentre, open, phase I study with genetically modified T cells (UniCAR02-T + TMpPSMA) for the treatment of patients with progressive PSMA-positive tumour disease after failure of standard therapy (in cooperation with the Department of Internal Medicine III of the UKU)

PCO study

Improving the quality of outcome in localised prostate cancer - international comparison of treatment and quality of outcome

Arasafe study:

A randomised phase II study comparing 3-weekly docetaxel 75 mg/m2 (in a 3-week cycle) with 2-weekly docetaxel 50 mg/m2 (in a 4-week cycle) in combination with darolutamide + ADT in patients with mHSPC

EvoPAR-Prostate 01:

A randomised, double-blind, placebo-controlled phase III study of AZD5305 in combination with novel hormonal agents of physician's choice in patients with HRRm and non-HRRm metastatic castration-sensitive prostate cancer

Further information on this clinical picture can be found here.

VOLGA
Randomised, open-label phase III study on the efficacy and safety of durvalumab + tremelimumab + enfortumab vedotin vs. durvalumab + enfortumab vedotin for the perioperative treatment of patients with muscle-invasive bladder cancer

BLC1003
Prospective, open-label, phase I study of the efficacy and safety of the intravesical erdafitinib-releasing delivery system TAR-210 in patients with bladder cancer and selected FGFR mutations or fusions (being tested as part of the study)

IMvigor-011

A double-blind, multicentre, randomised phase III trial of atezolizumab (anti-PDL1 antibody) versus placebo as adjuvant therapy in patients with high-risk muscle-invasive bladder cancer who are ctDNA-positive after cystectomy

BI 1403-0002

An open-label Phase Ia/Ib dose-escalation study combining BI 907828 with BI 754091 (ezabenlimab), followed by expansion cohorts, in patients with advanced solid tumours.

IMA401-101

Phase Ia/Ib first-in-human clinical trial to evaluate the safety, tolerability and initial anti-tumour activity of IMA401, a bispecific TCER molecule, in patients with relapsed and/or refractory solid tumours.

IMCODE004 (BO45230):

A randomised, multicentre, phase II, double-blind study of autogenous cevumeran plus nivolumab versus placebo plus nivolumab as adjuvant therapy in patients with high-risk muscle-invasive urothelial carcinoma.

 

CAAA617A1DE04:

A prospective, multicentre cohort study to observe experience with lutetium (177Lu) vipivotide tetraxetan in metastatic castration-resistant prostate cancer

 

Patient information

Taking part in a clinical trial can have several advantages. It gives you the chance to be treated with drugs that are not yet generally available.

In order to exclude unnecessary risks for you as a patient and to allow only medically useful studies, clinical studies must be authorised by independent experts from a higher federal authority (Federal Institute for Drugs and Medical Devices or Paul Ehrlich Institute) and the responsible ethics committees before they begin.

The active substances have already been tested in preliminary studies to ensure that they are tolerable and do not entail any increased health risks. You may also be taking part in a clinical trial to investigate the effectiveness of new combinations of medicines that have already been authorised. If you take part in a trial, you will receive close medical supervision at our trial centre so that potential problems can be identified at an early stage. However, a trial also requires that you attend the necessary regular appointments. Disadvantages may arise if a new treatment is less effective than expected or has no effect after all (see placebo-controlled study). Rarer side effects may also occur that were not previously known, even if the medication has already been used in previous studies.

A detailed consultation with your doctor is therefore essential before participating in a trial. Take enough time to ask questions. It is important to know that participation in a clinical trial is voluntary. Participants can terminate their participation at any time and without giving reasons.

Ask the doctors treating you in your practice or clinic about suitable trials as a possible sensible treatment alternative or if no established therapy is available. Clinical trials are usually, but not exclusively, offered in university clinics. You can first contact your urologist in private practice. If you are interested, you can also contact the respective study centres of the clinics directly. Due to the large number of studies, different studies are sometimes offered at different study centres. You can find an overview of clinical trials in Germany on the Internet in the "German Register of Clinical Trials" at www.drks.de.

No, you will not incur any costs by participating in a study. Participants and their accompanying persons will receive partial reimbursement of costs, e.g. for travelling expenses. Your study doctor can provide you with details. Please also speak to Mrs Geiger, Mrs Köse or your supervising doctors if you should nevertheless incur additional costs.

The aim of controlled studies is to unequivocally investigate the added benefit of a new therapy compared to the previous treatment. "Controlled" means that there is a comparative control group. As a rule, a comparison is made against the standard therapy (e.g. therapy A versus B). If no standard therapy is established, the new therapy can also be compared against a placebo (placebo-controlled studies).
In so-called 'randomised studies', you may not be able to decide for yourself which treatment arm, e.g. therapy A or B, you are assigned to, as this is done by drawing lots. In 'double-blind studies', neither the patient nor the doctor is informed about which treatment arm you are assigned to. This is to avoid influencing the perception of side effects, etc. However, a so-called "unblinding" can take place if this is medically necessary.

 

Participating clinics & co-operation partners

To ensure the best possible interdisciplinary care and treatment, we work closely with the urologists in private practice as well as with various specialist disciplines at the University Hospital (radiology, nuclear medicine, surgery, oncology, radiotherapy, pathology, outpatient pain clinic) and other external cooperation partners, including in regular tumour conferences.
If required, experienced therapists and counsellors from various fields are also available to you during your inpatient stay (e.g. psychologists, social counselling service, physiotherapists).