Clinical trials and active study projects
An Open-label study comparing lutetium (177Lu) vipivotide
tetraxetan (also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617) versus observation in PSMA positive OMPC.
Status: Recruitment open
EC No. / EU CT Number: 2022-502956-29-00 – PI: Gero Kramer
Contact: Tel. +43 1 40400 60432
E-Mail: nadine.rainer@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
Saruparib (AZD5305) vs Placebo in Men with Metastatic Castration-Sensitive Prostate Cancer Receiving Physician’s Choice New Hormonal Agents
Status: Recruitment open
EK-Nr bzw. EU CT Nummer.: 2023-504214-30-00 – PI: Gero Kramer
Contact: Tel. +43 1 40400 60432
E-Mail: nadine.rainer@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
Phase 3 Study of Xaluritamig Plus Abiraterone vs Investigator’s Choice in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cance.
Status: Recruitment open
EK-Nr bzw. EU CT Nummer.: 2025-520555-89 – PI: Gero Kramer
Contact: Tel. +43 1 40400 60432
E-Mail: nadine.rainer@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in
Subjects With Progressive Metastatic Castration-Resistant Prostate Cancer.
Status: Recruitment open
Ek-Nr bzw. EU CT Nummer.: 2024-513968-25
Contact: Tel. +43 1 40400 60434
E-Mail: irene.hofgartner@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
An open-label study of JSB462 (luxdegalutamide) in combination with lutetium (177Lu) vipivotide tetraxetan in adult male patients with PSMA-positive metastatic castration resistant prostate cancer (mCRPC).
Status: Recruitment open
Ek-Nr bzw. EU CT Nummer.: 2024-520155-24
Contact: Tel. +43 1 40400 60430
E-Mail: aravind.sajeev@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
A Phase 3 Study Comparing BMS-986365 versus Investigator’s Choice of Therapy in Participants with Metastatic Castration-resistant Prostate Cancer.
Status: Recruitment temporarily closed. Recruitment will reopen.
EK-Nr. bzw. EU CT Nummer.: 2024-517422-25
Contact: Tel. +43 1 40400 60434
E-Mail: irene.hofgartner@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
Long-Term Safety of lutetium (177Lu) vipivotide tetraxetan in Participants with Prostate Cancer.
Status: Recruitment open (for patients who were previously enrolled in PSMAddition and PSMAfore)
EK-Nr. bzw. EU CT Nummer.: 2023-503208-94-00
Contact: Tel. +43 1 40400 60432
E-Mail: nadine.rainer@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
177Lu-PSMA-617 in combination with standard treatment compared with standard treatment alone in adult male patients with metastatic hormone-sensitive prostate cancer (mHSPC). An international, prospective, open-label, randomized phase III study.
Status: Recruitment closed
EK Nr: 1430/2021. PI Gero Kramer
Contact: Tel. +43 1 40400 60432
E-Mail: nadine.rainer@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
177Lu-PSMA-617 compared with a change in androgen receptor–targeted therapy for the treatment of men with progressive metastatic castration-resistant prostate cancer without prior taxane therapy. An open-label, multicenter, randomized phase III study.
Status: Recruitment closed
EK Nr: 1201/2021. PI Gero Kramer
Contact: Tel. +43 1 40400 60432
E-Mail: nadine.rainer@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
A non-interventional study of darolutamide in patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
Status: Recruitment closed
Contact: Tel. +43 1 40400 60432
E-Mail: nadine.rainer@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
Prospective, Multi‐Country, Observational Study of Clinical Outcomes for Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With ADT plus Apalutamide or Enzalutamide Under Routine Clinical Practice.
Status: Recruitment closed
EK-Nr. bzw. EU CT Nummer: 1304/2023
Contact: Tel. +43 1 40400 60432
E-Mail: nadine.rainer@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
Phase 3 study of darolutamide plus ADT compared with ADT in high-risk BCR.
Status: Recruitment closed
EK-Nr. bzw. EU CT Nummer: 1412/2023
Contact: Tel. +43 1 40400 60432
E-Mail: nadine.rainer@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
A Randomized, Open-Label, Phase 2/3 Trial of Izalontamab Brengitecan versus Platinum-based Chemotherapy for metastatic Urothelial Cancer in Participants with Disease Progression on or after an Immunotherapy-based Treatment
Status: Recruitment open
EU-CT-Nummer: 2025-522400-24
Contact: Tel. +43 (0)1 40400-60434
E-Mail: irene.hofgartner@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants with Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
Status: Recruitment open
EU-CT-Nummer: 2023-504231-41-00
Contact: Tel. +43 (0)1 40400-60434
E-Mail: irene.hofgartner@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
Studies with neoadjuvant therapy
A randomized phase III study of neoadjuvant chemotherapy alone versus chemotherapy with nivolumab or nivolumab and BMS-986205 (IDO1), followed by postoperative maintenance therapy with nivolumab or nivolumab and BMS-986205 (IDO1), in male and female participants with muscle-invasive bladder cancer.
Status: Recruitment closed
EK Nr: 1131/2018. PI Shahrokh F. Shariat + Kilian Gust
Kontakt: Tel. +43 (0)1 40400-26270
E-Mail: irene.hofgartner@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
A randomized phase III study of neoadjuvant and adjuvant nivolumab plus NKTR-214 compared with nivolumab alone versus standard of care in patients with muscle-invasive bladder cancer who are not eligible for cisplatin therapy.
Status: Recruitment open
EK Nr: 1273/2019
Contact: Tel. +43 (0)1 40400-26270
E-Mail: irene.hofgartner@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
Studies in muscle-invasive bladder cancer
PET imaging for staging and prognostic assessment of urothelial carcinomas.
Status: Recruitment open
EK Nr: 1238/2022. PI Shahrokh F. Shariat
Contact: Tel. +43 (0)1 40400-26310
E-Mail: ekaterina.laukhtina@meduniwien.ac.at
A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants with Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations
Status: Recruitment closed
EU-CT-Nummer: 2023-507684-19
Contact: Tel. +43 (0)1 40400-60434
E-Mail: irene.hofgartner@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
A Phase III Randomized, Open-Label, Multicenter Study to determine the Efficacy and Safety of Durvalumab in Combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination with Enfortumab Vedotin for perioperative treatment in patients ineligible for Cisplatin or who refuse Cisplatin undergoing Radical Cystectomy for muscle-invasive Bladder Cancer
Status: Recruitment closed
EK-Nummer: 1711/2021
Contact: Tel. +43 (0)1 40400-60434
E-Mail: irene.hofgartner@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Bacillus Calmette-Guerin (BCG) in Participants with High-risk Non-Muscle invasive Bladder Cancer (HR-NMIBC) that is either persistent or recurrent following BCG Induction or that is naive to BCG Treatment. (Keynote 676)
Status: Recruitment closed
EK-Nummer: 1286/2019
Contact: Tel. +43 (0)1 40400-60434
E-Mail: irene.hofgartner@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
A Phase 3, Multi-center, Randomized Study evaluating Efficacy of TAR-200 in Combination with Cetrelimab versus concurrent Chemoradiotherapy in Participants with muscle-invasive Urothelial Carcinoma (MIBC) of the Bladder who are not receiving Radical Cystectomy
Status: Recruitment closed
EK-Nummer: 2382/2020
Contact: Tel. +43 (0)1 40400-60434
E-Mail: irene.hofgartner@meduniwien.ac.at
E-Mail: bianca.ladman@meduniwien.ac.at
An open-label, randomized phase III study of MK-6482 in combination with lenvatinib (MK-7902) versus cabozantinib in participants with advanced renal cell carcinoma whose disease has progressed following prior anti–PD-1/L1 therapy.
Status: Recruitment closed
EK Nr: 220805/2020. PI Manuela Schmidinger
Contact: Tel.:+43 (0)1 40400-60430
E-Mail: sandra.etz@meduniwien.ac.at
A randomized first-line study to optimize the treatment of patients with metastatic renal cell carcinoma.
Status: Recruitment open
EU CT Nr.: 2023-503317-29-00. PI Manuela Schmidinger
Contact: Tel.:+43 (0)1 40400-60430
E-Mail: sandra.etz@meduniwien.ac.at
A randomized, open-label, phase III clinical study of belzutifan plus zanzalintinib compared with cabozantinib in participants with advanced renal cell carcinoma (RCC) who experienced disease recurrence during or after prior adjuvant anti–PD-1/L1 therapy.
Status: Recruitment open as of study initiation on 10 February 2026
EU CT-Nr.: 2024-517136-21. PI Manuela Schmidinger
Contact: Tel.:+43 (0)1 40400-60430
E-Mail: sandra.etz@meduniwien.ac.at