Current research projects

OPTILUME: European Clinical Registry for Optilume® Urethral Drug Coated Balloon. PR1276-001 Rev B.

This registry involves recruitment of male patient undergoing anterior urethra dilation with the Optilume® Drug Coated Balloon Device. For the full description of the registry, please visit the ClinicalTrials.gov website. For more information, please contact the EAU RF.

VENUS: Prospective Registry for Patients Undergoing Artificial Urinary Sphincter Surgery for Female Stress Urinary Incontinence due to intrinsic sphincter deficiency. EAU-RF 2019-01

This study involves recruitment of female patients undergoing artificial urethral sphincter implantation surgery (e.g. robot-assisted, laparoscopic, open or other) for treatment of stress urinary incontinence due to intrinsic sphincter deficiency. For the full description of the registry, please visit the ClinicalTrials.gov website. For more information, please contact the EAU RF.

PHOENIX: Prospective Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction. EAU-RF 2018-01

The PHOENIX study is actively recruiting male patients who are undergoing a surgical penile prosthesis implantation for treatment of erectile dysfunction. For more information on the study, please visit ClinicalTrials.gov website or contact the EAU RF.

The Prostate Imaging using MRI +/- contrast Enhancement (PRIME) study is an international multi-centre prospective diagnostic test evaluation of bi-parametric MRI (bpMRI). The study assesses whether bpMRI is non-inferior to multiparametric MRI (mpMRI) in the diagnosis of clinically significant prostate cancer (PCa).

As per standard of care, men with clinical suspicion of PCa undergo mpMRI. The radiologist reviewing the scan will be asked to review the MRI scan in a different order than usual to investigate whether bpMRI can offer the same degree of accuracy of detecting PCa as mpMRI.

Please visit the study’s official website and check out the full description on the Clinicaltrials.gov website. To know more, please contact the EAU RF.

The European Active Surveillance of Renal Cell Carcinoma (EASE RCC) study will include a total of 400 patients with small, incidentally detected, and histologically confirmed RCC. Data related to the oncological outcomes of an active surveillance approach will also be collected. Please find the full description of the study via the Netherlands Trial Register. Please contact Dr. Alessandro Volpe for more information.

MARS: ManAgement of pRiapiSm and its impact on outcomes: an international register. NCT04932902

The MARS study is an international multicentre observational study that aims to shed light on what may be the responses to medical surgical treatment in patients with priapism, and set up a rational data collection that has solid scientific bases. More details on the study are available via the Clinicaltrials.gov website. For more information, please contact the EAU RF.

ROGUE-1: Multicentric prospective T1 urinary bladder cancer registry

This study strives to prospectively collect data from patients with a primary diagnosis of stage T1 urothelial bladder cancer (T1 UBC) and create a platform that will answer several clinically relevant questions. Studies originating from this registry could potentially change the risk stratification and as consequence, the management of patients with T1 UBC. Please contact Dr. David D′Andrea for more information.

SATURN: Prospective Registry for Patients Undergoing Surgery for Male Stress Urinary Incontinence in Multiple European Centres. EAU-RF 2016-01

The SATURN study has recruited over 1,000 male patients who have undergone surgery for the treatment of stress urinary incontinence through the use medical devices such as artificial urethral sphincter or sling. The full description of the registry is available on the ClinicalTrials.gov website. For more information, please contact the EAU RF.

PEGASUS: Open-label, single-arm, Phase II study, evaluating safety and efficacy of INCB054828 (Pemigatinib) as adjuvant therapy for molecularly-selected, high-risk patients with urothelial carcinoma who have received radical surgery. A European Association of Urology Research Foundation Phase II Clinical Trial. Protocol Number: EAU-RF 2018-02. Eudract Number: 2019-001833-14

Patients with pT3-4 and/or pN1-3 stage urothelial cancer who underwent radical cystectomy or radical nephroureterectomy with documented FGF/FGFR alterations have been recruited from urology departments in European hospitals participating in this study. Please find the full description of the study on the Clinical trials.gov website. For more information, please contact the EAU RF.

EVOLUTION: European registry evaluating management practices of general practitioners and urologists and pharmacological treatment outcomes in patients with Lower Urinary Tract Symptoms associated with Benign Prostatic Hyperplasia (LUTS/BPH). Protocol Number: EAU-RF 08-02

This is a registry conducted within a sample of European Union (EU) general practitioner (GP) outpatient clinics and hospital or office-based clinics of urologists. There were 2,175 patients registered in 5 European countries (the United Kingdom, France, Germany, Italy, and Spain).

Across the different countries, the registry collected real-life data on the following:

• Usual management of Lower Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH)
• Effect of LUTS/BPH and its pharmacological treatment outcomes on LUTS/BPH-related health status, general quality of life, and sexual function.

Please find the full description of the trial on the NederlandsTrial Register. For more information, please contact the EAU RF.

ZEUS: Effectiveness of Zometa® treatment for the prevention of bone metastases in high risk prostate cancer patients. A randomized, open-label, multicenter study of the European Association of Urology (EAU) in Cooperation with the Scandinavian Prostate Cancer Group (SPCG) and the Arbeitsgemeinschaft Urologische Onkologie (AUO). Protocol Number. CZOL446G DE08 Eudract Number 2004-001786-18

For this study, 1,433 patients who have at least one of the following prognostic factors: PSA > 20 ng/mL, N+ disease and/or a Gleason score of 8-10, were randomised for standard PCa therapy plus 4 mg Zoledronic acid intravenously 3 monthly for 48 months or standard PCa therapy alone. For more information, please visit the European Union Clinical Trials Register and/or contact the EAU RF.

MAGNOLIA: A randomized, double blind, placebo controlled phase II trial to evaluate the safety and efficacy of recMAGE-A3 + AS15 ASCI in patieNts with MAGE-A3 pOsitive muscLe Invasive blAdder cancer after cystectomy. A European Association of Urology Research Foundation Randomized Phase II Clinical Trial. Number: EAU-RF 2010-01. Eudract Number: 2010-019181-91

The MAGNOLIA study was open to male and female patients with pathologically confirmed muscle invasive transitional cell carcinoma of the urinary bladder with expression of the antigen MAGE-A3 with or without limited lymph node involvement who had no evidence of disease after radical cystectomy confirmed with imaging procedures (e.g. CT or MRI scans). The full description of the MAGNOLIA study is available on the European Union Clinical Trials Register.

NIMBUS: Treatment of High-Grade Non-Muscle Invasive Urothelial Carcinoma of the Bladder by Standard Number and Dose of Intravesical BCG Instillations versus Reduced Number of Intravesical Instillations with Standard Dose of BCG. A European Association of Urology Research Foundation Randomized Phase III Clinical Trial. Protocol Number: EAU-RF 2008-01. Eudract Number: 2010-019181-91

The NIMBUS study assessed whether a reduced number of Bacillus Calmette-Guerin (BCG) instillations is not inferior to the standard number and dose of intravesical BCG treatment in patients with high-grade non-muscle invasive bladder cancer. Visit the European Union Clinical Trials Register for the full description of the study. For more information, please contact the EAU RF.

The PRostate Evaluation for Clinically Important disease: Sampling using Image-guidance Or Not? (PRECISION) is a randomised controlled study of magnetic resonance imaging-targeted biopsy compared to standard transrectal ultrasound guided biopsy for the diagnosis of PCa in men without prior biopsy.

Men with clinical suspicion of PCa were randomised 1:1 to mpMRI or to 10-12 core standard TRUS-biopsy. In the MRI arm, if there was a suspicious lesion on mpMRI, the men underwent MRI-targeted prostate biopsy (up to 12 cores). If there was no suspicious lesion on mpMRI, the men did not undergo biopsy as part of protocol but reverted to standard of care management instead.

Please find the full description of the study via the ISRCTN Trial Register and the Clinicaltrials.gov website.

The study is a prospective, randomised study on the effect on survival of hormonal treatment versus hormonal treatment plus external radiotherapy of the prostate in patients with primary metastatic (bone) prostate cancer.

In the HORRAD study, the patients are randomised into two groups:

• Group 1: hormone treatment by means of an analogous LHRH (Pamorelin) every 3 months and an anti-androgen (Casodex 50 mg 1dd 1) for 4 weeks, to start 1 to 2 weeks before the first administration of the analogous LHRH
• Group 2: hormone treatment by means of an analogous LHRH (Pamorelin) every 3 months and an anti-androgen (Casodex 50 mg 1dd 1) for 4 weeks, to start 1 to 2 weeks before the first administration of the analogous LHRH, combined with local external radiotherapy (70 Gray) of the prostate.

For the full description of the study, please visit the NederlandsTrial Register.