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Clinical Trials on Genitourinary Tumors

Bladder Cancer (including Urinary Tract)

Title in German	Analyse zirkulierender Tumor-DNA als prognostischer Biomarker bei muskelinvasivem Blasenkrebs.
Title in English	Analysis of circulating tumor DNA as a prognostic biomarker in muscle invasive bladder cancer.
Description
Head Clinical Trial	Tobias Grob
Study-Nurse
Back-up	Ursula Amstutz
Status	open
BASEC Nummer	2018-01152
KOFAM	STD0005489
Insel-Nummer	9955

Title in German	Studie zur ausführlichen immunologischen Charakterisierung von Patienten mit Harnblasenkarzinom
Title in English	Study for the detailed immunological characterization of patients with bladder cancer
Description	Prospective clinical cohort study, with planned various subgroup analyses. We plan the detailed immunological characterization of patients with bladder cancer who have to undergo surgical treatment. The comparison population is, on the one hand, a patient collective without an underlying malignant disease with comparable surgical trauma and, on the other hand, a subgroup comparison of geriatric (over 65 years of age) and non-geriatric patients is to be carried out. The aim is to identify immunological patterns that may enable therapeutic influence or better predict the response to an established therapy. Ultimately, this is a first step towards individualized therapy for geriatric patients with this important urological tumor disease. From the data collected, in particular from the inflammatory cytokines in the urine, biomarker panels can be developed that enable a better prediction of the disease progression of urinary bladder cancer.
Head Clinical Trial	Prof. Dr. med. Bernhard Kiss
Study-Nurse	Anselm Lafita
Back-up	Studienmanagement Urologie
Status	open
BASEC Nummer	2022-00784
Insel-Nummer	5345

Title in German	Die Rolle der präoperativen Immunernährung auf Morbidität und Immunantwort nach Zystektomie – Eine multizentrische, randomisierte, kontrollierte Studie
Title in English	The role of preoperative immunonutrition on morbidity and immune response after cystectomy - A multicenter randomized controlled trial
Description	This is a multicenter study that is only being carried out in Switzerland. The study is open to patients undergoing surgery in three Swiss hospitals (CHUV in Lausanne, Hôpital de l'Ile in Bern and HRC in Rennaz). There will be two groups of participants. The first group receives immunonutrition before cystectomy. The second group, the so-called control group, does not receive it. Patient repairs are carried out by lottery. The planned duration of study is 4 years. The main purpose of the study is to investigate infectious complications within 30 days after surgery.
Head Clinical Trial	Prof. Dr. med. Bernhard Kiss
Study-Nurse	Anselm Lafita
Back-up	Studienmanagement Urologie
Status	open
BASEC-Nummer	2022-01528
Kofam-Nummer	SNCTP000005406
WHO-Register-Nummer	NCT05726786
Insel-Nummer	5429

Title in German	Durvalumab in Kombination mit Standard Chemotherapie bei Patienten mit einem operablen Karzinom des Harntrakts. Eine multizentrische einarmige Phase II Studie.
Title in English	Neoadjuvant and adjuvant durvalumab in combination with neoadjuvant chemotherapy in patients with operable urothelial cancer. A multicenter, single-arm phase II trial
Description	The study examines the combination of standard therapy with durvalumab. The aim of the study is to improve the prognosis of affected patients and to investigate the effect and tolerability of the antibody durvalumab in this situation. This study is being carried out at several hospitals in Switzerland and Germany. 61 patients will be included in the study. All study participants will receive the same treatment. This consists of standard therapy (chemotherapy before the operation and subsequent operation) and the additional administration of the study drug durvalumab (an immunotherapy). The duration of treatment is 3 months before the operation and 9 months after. Durvalumab is a protein that activates the body's immune system (“immunotherapy”). Durvalumab is not yet approved as a drug in Switzerland.
Head Clinical Trial	Prof. George Thalmann
Study-Nurse	Barbara Uhlmann Weber
Back-up	Anselm Lafita
Status	Follow-up
BASEC-Nummer	2018-00176
Insel-Nummer	3690

Title in German	Multiparametrische MRI von Blasenkarzinomen
Title in English	Multiparametric MRI to improve bladder cancer staging and treatment decision-making
Descriptioin	Multiparametric MRI of bladder cancer (Multiparametric MRI to improve bladder cancer staging and treatment decision-making)
Head Clinical Trial	PD Dr. med. Verena Carola Obmann
Study-Nurse	Anselm Lafita
Back-up	Prof. Dr. med. Bernhard Kiss
Status	open
BASEC Nummer	2020-02083
Insel-Nummer	4683

Title in German	Der Effekt von TNF-α Inhibitoren auf eine obstruktive Blasenentleerungsstörung
Title in English	The effect of TNF-α inhibitors on obstructive bladder outlet symptoms
Description	BOO leads to a reduced urinary flow during voiding (Qmax [ml/s]). Qmax can be measured with non-invasive pressure flow procedures. Decreased flow can result in significant residual urine after bladder emptying. Residual urine is measured non-invasively by ultrasound. Primary endpoint would be a lower IPSS, improvement on patient’s quality of life and bladder function. If there is a change in the process of fibrosis in the bladder itself we expect to measure a change in the biomarkers collected in the urine samples. Secondary endpoints would be an increase of urinary flow during bladder voiding and a reduction of residual urine.
Head Clinical Trial	Prof. Dr. med. Fiona Burkhard
Study-Nurse	Anselm Lafita
Back-up	Prof. Dr. med. Burkhard Möller
Status	open
BASEC Nummer	2021-02061
Insel-Nummer	5125

Testicular Cancer

Title in German	Radio-Chemotherapie mit reduzierter Intensität bei Patienten mit einem Seminom (Hodenkrebs) des Stadiums IIA/B. Eine multizentrische, offene Phase-II-Studie mit zwei Patientengruppen
Title in English	Reduced intensity radio-chemotherapy for stage IIA/B seminoma. A multicenter, open label phase II trial with two cohorts
Description	The study will examine whether and how the treatment of men with seminoma (testicular cancer) can be improved. In the study, patients will be treated with a combination of chemotherapy and radiation therapy at reduced intensity. We want to find out whether this form of attenuated therapy is effective compared to usual therapy, whether possible side effects can be avoided and how this affects patients' quality of life.
	This study is being carried out in Switzerland and Germany. A total of around 135 patients are taking part. The drugs used in the study as chemotherapy are carboplatin (stage IIA) and cisplatin/etoposide (stage IIB and IIA), which are common in the treatment of testicular cancer in Switzerland. The study therapy lasts around six weeks. Each participant will then be monitored at regular intervals for 20 years.
Phase/Biobank/ect.	Phase II
Head Clinical Trial	PD Dr. med. Mohamed Shelan
Co-Investigator	Prof. Dr.med. Jörg Beyer
Back-up	Antje Kramer
Status	aktive since 18.07.2019
BASEC Nummer	2019-00796
KOFAM	SNCTP000003335
WHO-Register-Nummer	NCT02051218

Title in German	Schweizerisch-österreichisch-deutsche Hodenkrebs-Kohortenstudie. Sagen Sie TCCS
Title in English	Swiss Austrian German Testicular Cancer Cohort Study. SAG TCCS
Phase	Kohorten Studie
Head Clinical Trial	Prof. Dr. med. Jörg Beyer
Study Nurse	Barbara Uhlmann
Status	temporarly closed 2023
BASEC Nummer	PB_2016-00235
WHO-Register-Nummer	NCT02229916
Insel-Nummer	4430

Kidney Cancer

Prostate Cancer

Title in German	Wirksamkeit des SpaceOAR Vue-Systems bei Patienten mit Prostatakrebs, die mit der stereotaktischen Körperstrahlentherapie (SABRE) behandelt werden (U0702)
Title in English	Effectiveness of the SpaceOAR Vue System in Subjects with Prostate Cancer being Treated with Stereotactic Body RadiothErapy (SABRE)
Description	This study aims to investigate the effectiveness of the SpaceOAR medical device. The SpaceOAR Vue system is a hydrogel that creates a space between the rectum and the prostate, which can help minimize the side effects of cancer radiation therapy.
	The prostate is located next to the rectum and is naturally separated by a small space called the perirectal space. – The SpaceOAR Vue System Hydrogel is inserted into the space between the rectum and prostate using a needle. Because of the proximity, prostate radiotherapy can inadvertently cause damage to the rectum, which can lead to problems with bowel function. – By acting as a spacer, the hydrogel temporarily moves the rectum away from the prostate. By separating the rectum from the prostate, the SpaceOAR Vue system reduces the amount of radiation received by the rectum and can reduce damage to the rectum.
	Patients are assigned to one of two groups by a computer program; Approximately 333 study participants will receive the SpaceOAR Vue System Hydrogel and are considered part of the treatment group and approximately 167 will not receive the SpaceOAR Vue System Hydrogel and are considered part of the control group. The treatment group may also receive reference markers to support radiotherapy. The reference markers are placed at the physician's discretion. – Stereotactic radiation (SBRT) is then administered. The control group may also receive fiducial markers to support radiotherapy, but not the SpaceOAR Vue System, at the physician's discretion. Stereotactic radiation is then administered.
	Data will be collected and recorded before, during and after SBRT treatment. These visits occur at 3, 6, 12, 18, 24, 36, 48 and 60 months after the start of radiotherapy. Participation in the study is completed after 5 years.
Phase/Biobank etc.
Head Clinical Trial	PD Dr. med. M. Shelan
Study-Nurse
Back-up
Status	Aktive since 01.04.2023
BASEC Nummer	2022-D0042
KOFAM	SNCTP000005130
WHO-Register-Nummer	NCT04905069
Insel-Nummer

Title in German	Eine konfirmatorische, prospektive, offene, einarmige, Auswerter-verblindete, multizentrische Phase-3-Studie zur Beurteilung der diagnostischen Genauigkeit der mit Ferumoxtran-10-verstärkten Magnetresonanztomographie (MRT) und des unverstärkten MRTs in Bezug auf die Histopathologie bei neu diagnostizierten Patienten mit Prostatakrebs (PCA), für die eine radikale Prostatektomie (RP) mit erweiterter Beckenlymphknotensektion (ePLND) geplant ist.
Title in English	A Confirmatory, Prospective, Open-label, Single-arm, Reader-blinded Multi-centre Phase 3 Study to Assess the Diagnostic Accuracy of Ferumoxtran-10-enhanced Magnetic Resonance Imaging (MRI) and Unenhanced MRI in Reference to Histopathology in Newly-diagnosed Prostate Cancer (PCA) Patients, Scheduled for Radical Prostatectomy (RP) With Extended Pelvic Lymph Node Dissection (ePLND).
Description	The study investigates whether Ferumoxtran-10 is suitable as a contrast agent for magnetic resonance imaging (MRI) examinations for the detection of small lymph node metastases in the pelvis in prostate cancer. We are doing this study to investigate the diagnostic accuracy and safety of ferumoxtran-10. The study is intended for people who have prostate cancer and are at moderate to increased risk of metastases to the pelvic lymph nodes and are therefore scheduled for removal of the prostate and pelvic lymph nodes.
	Ferumoxtran-10 consists of very small iron-containing particles and is sensitive and specific for the detection of lymph node metastases. A solution of Ferumoxtran-10 is administered intravenously, i.e. through an injection directly into the vein, and is absorbed by the tissue of healthy lymph nodes, but not by the cancerous tissue.
	During imaging of the pelvic region using an MRI scan, the distributed ferumoxtran-10 particles can be detected. Healthy tissue appears darker, while cancerous tissue appears lighter. This method allows the smallest metastases as small as 2mm to be detected, in contrast to conventional MRI scans, which only detect metastases as small as 7-8mm.
Phase	III
Studienleiter	Prof. Dr. Dr. med. Johannes Heverhagen
Study-Nurse	Anselm Lafita
Back-up	Jana Hoppe
Status	aktive since August 2020
BASEC Nummer	2019-02140
KOFAM	NCT04261777
WHO-Register-Nummer	DRKS00019106
Insel-Nummer	4318

Title in German	Studie zur Sicherheit und Wirksamkeit einer gezielten, hochdosierten Bestrahlung eines einzelnen wiederauftretenden Tumorknotens im Prostatabett nach ursprünglicher Prostataentfernung
Title in English	A single arm phase II trial for ultrahypofractionted salvage radiotherapy for isolated prostate bed recurrence after radical prostatectomy
Description	If prostate cancer recurs in the area of the former prostate, radiotherapy to the prostate bed is carried out as standard with a certain dose and a targeted increase in dose to the visible tumor that has recurred (local recurrence) in combination with parallel anti-hormonal therapy in order to prevent the progression of the disease. In our research project, we want to find out whether high-dose targeted radiation therapy for local recurrence with parallel antihormonal therapy has the same safety and effectiveness.
Phase/Biobank etc.	Phase II
Head Clinical Trial	PD Dr. med. M. Shelan
Study-Nurse
Back-up
Status	active since 27.2.2023
BASEC Nummer	2022-01026
KOFAM	SNCTP000005372
WHO-Register-Nummer	NCT05746806
Insel-Nummer

Title in German	Klinisch relevante Tierversuchsmodelle für urogenitale Tumoren
Title in English	Clinically relevant animal models for urogenital tumors
Description	In order to understand the development of cancer cells and to improve the chances of recovery from cancer, we would like to continue to culture your prostate cancer tissue in laboratory animals. In the case of prostate tumors, the progression of the disease can be slowed down by withdrawing male hormones. This effect usually disappears after one to two years and hormone-resistant growth develops. In addition to researching the genetic changes that underlie prostate cancer, we also want to investigate the genetic changes that underlie hormone-resistant growth. The aim of this study is therefore to develop clinically relevant animal models for prostate cancer.
Head Clinical Trial	Prof. Dr. med. George Thalmann
Study-Nurse	Anselm Lafita
Back-up
Status	open
BASEC Nummer	153/13
KOFAM	STD0003369
Insel-Nummer	2436

Title in German	Eine internationale, prospektive, offene, randomisierte Phase-III-Studie zum Vergleich von 177Lu-PSMA-617 in Kombination mit Standardversorgung gegenüber Standardversorgung alleine bei erwachsenen Männern mit metastasiertem, hormonsensitivem Prostatakrebs (mHSPC)
Title in English	An International Prospective Open-Label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
Description	Prostate cancer is a malignant disease of the prostate gland. If the cancer has spread beyond the prostate into the body, it is called metastatic. Prostate cancer can be blocked or stopped with hormone therapy to slow cancer growth (hormone sensitive). Many prostate cancer cells have a protein called prostate-specific membrane antigen (PSMA) on their surface. The test substance we are investigating in this study is called ¹⁷⁷Lu-PSMA-617. It is a radionuclide therapy that binds to prostate cancer cells with PSMA proteins on their surface and uses lutetium-177 radiation to kill these cancer cells. The amount of radiation selected is high enough to damage and destroy the tumor cells and low enough to reach the tumor cells throughout the body via the bloodstream without damaging healthy, normal tissue. This new drug has already been tested in Switzerland, but has not yet been approved by any health authority for the treatment of people with the same condition as yours. The purpose of this study is to compare the new test substance called ¹⁷⁷Lu-PSMA-617 together with the Standard treatment versus standard treatment alone. The probability of receiving one of the following study treatments is fifty-fifty (like flipping a coin).
Phase	3
Head Clinical Trial	Prof. Dr. med. Jörg Beyer
Sub-Investigator Nuklearmedizin	Prof. Dr. med. Ali Afshar Oromieh
Study-Nurse	Lone Steinmann
Status	closed for patient recruitment: 20.06.2023
BASEC Nummer	2021-00688
Insel Nummer	5109
Kofam Nummer	SNCTP000004759
EudraCT number	NCT04720157

Penile Carcinoma

Other Clinical Trials on Uro-Oncology

Title in German	Organoide, ex-vivo-Gewebekulturen und von Patienten stammende Xenotransplantate für die Behandlungsentscheidung bei Patienten mit urologischen Tumoren.
Title in English	Organoids, ex vivo tissue culture and patient derived xenografts for treatment decision making in patients with urological tumors.
Description	To establish organoids, ex-vivo tumor tissue cultures and PDX from tumors of patients with urological cancers, i.e. prostate cancer, urothelial cancer, kidney cancer and testicular cancer. Once established, robust and representative, these can be used specifically to test genomic/gene expression changes in response to treatment and to test established and new treatment strategies in patient care prior to initiation of treatment.
Head Clinical Trial	Prof. Dr. med. George Thalmann
Study-Nurse	Anselm Lafita
Status	open
BASEC Nummer	2017-02295
KOFAM	STD0004480
Insel-Nummer	3584