Therapeutic innovation and clinical research in uro-oncology

Line 3

This line drives the clinical evaluation of new diagnostic and therapeutic strategies through observational studies, clinical trials and translational research, with the aim of improving the management and survival of patients with genitourinary cancer.

This line brings together clinical care and research to accelerate the transfer of scientific knowledge into clinical practice.

Its activities include the design and conduct of clinical trials, prospective studies and multicentre projects aimed at evaluating new therapeutic options and optimising available treatments. We analyse prognostic and predictive factors of response, real-world outcomes and patients’ unmet needs.

The line also promotes the clinical validation of biomarkers and precision medicine tools developed in the preclinical setting. It covers targeted therapies, immunotherapy and combination strategies, supporting a personalised approach to the treatment of genitourinary cancer.

Its purpose is to generate high-quality scientific evidence that helps improve patients’ survival, quality of life and comprehensive care.

Projects and studies in this line

Project / studyTypeCancer typeSponsor / fundingPI
ARANOTEDarolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in metastatic hormone-sensitive prostate cancerClinical trial · Phase IIIProstateBayer AGBernardo Herrera Imbroda
ARASTEPDarolutamide plus ADT versus placebo plus ADT in high-risk biochemically recurrent prostate cancerClinical trial · Phase IIIProstateBayer AGBernardo Herrera Imbroda
PROTEUSApalutamide plus ADT versus placebo plus ADT in high-risk localised or locally advanced prostate cancer in candidates for radical prostatectomy56021927PCR3011Clinical trial · Phase IIIProstateJanssen-CilagBernardo Herrera Imbroda
Apalutamide in high-risk localised or locally advanced prostate cancer receiving primary radiotherapyClinical trial · Phase IIIProstateJanssen-CilagRaquel Correa Generoso
EvoPAR-Prostate02Adjuvant saruparib (AZD5305) in high-risk localised BRCA-mutated prostate cancer treated with radiotherapy and ADTClinical trial · Phase IIIProstateAstraZeneca
TEAM PCTalazoparib plus enzalutamide as first-line treatment for metastatic castration-resistant prostate cancer after progression on abirateroneClinical trial · Phase IIProstateFundación OncosurBernardo Herrera Imbroda
DE-ESCALATEIntermittent androgen deprivation therapy in metastatic hormone-sensitive prostate cancer in the era of new androgen receptor pathway inhibitorsClinical trialProstate
ADT with or without local radiotherapy and with or without abiraterone and prednisone in metastatic hormone-sensitive prostate cancerClinical trial · Phase IIIProstateUNICANCERRaquel Correa Generoso
Oral darolutamide (ODM-201) versus androgen deprivation therapy with LHRH agonists or antagonists in men without prior hormone therapyClinical trial · Phase IIProstateHospital Universitario de SalamancaBernardo Herrera Imbroda
EPI-7386 plus enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancerClinical trial · Phase I/IIProstateESSA PharmaRocío Santos Pérez de la Blanca
PROCADEOral HC-1119 versus enzalutamide in metastatic castration-resistant prostate cancerClinical trial · Phase IIIProstateHinova PharmaceuticalsDavid Hernández Alcaraz
PEGASUSRadiotherapy plus adjuvant androgen suppression with a GnRH antagonist versus agonist in very high-risk prostate cancerEORTC-GUCG 1532Clinical trial · Phase IIIbProstateEORTCAna María Otero Romero
177Lu-PSMA-I&T versus hormone therapy in metastatic castration-resistant prostate cancerClinical trial · Phase IIIProstateCuriumDavid Hernández Alcaraz
Hypofractionated postoperative radiotherapy in patients with prostate cancer (multicentre study)Clinical trial · Medical deviceProstateGICORAna María Otero Romero
ABLE-22Intravesical nadofaragene firadenovec alone or combined with chemotherapy or immunotherapy in BCG-unresponsive high-grade non-muscle-invasive bladder cancer with CISClinical trial · Phase IIIBladderFerring
ABLE-32Nadofaragene firadenovec versus observation in intermediate-risk non-muscle-invasive bladder cancerClinical trial · Phase IIIbBladderFerring
SunRISe-1TAR-200 with cetrelimab, TAR-200 alone or cetrelimab alone in BCG-unresponsive high-risk NMIBCClinical trial · Phase IIbBladderJanssen-CilagBernardo Herrera Imbroda
SunRISe-3TAR-200 with cetrelimab or TAR-200 alone versus intravesical BCG in BCG-naïve high-risk NMIBCClinical trial · Phase IIIBladderJanssen-CilagBernardo Herrera Imbroda
SunRISe-4TAR-200 with cetrelimab and cetrelimab monotherapy in muscle-invasive urothelial bladder carcinoma before radical cystectomyClinical trial · Phase IIBladderJanssen-CilagBernardo Herrera Imbroda
SunRISe-5TAR-200 versus intravesical chemotherapy in high-risk NMIBC recurring after BCG, in patients not eligible for cystectomyClinical trial · Phase IIIBladderJanssen-CilagBernardo Herrera Imbroda
MoonRISe-1TAR-210 erdafitinib intravesical system versus intravesical chemotherapy in intermediate-risk NMIBC with FGFR alterationsClinical trial · Phase IIIBladderJanssen-CilagBernardo Herrera Imbroda
MoonRISe-3TAR-210 versus intravesical chemotherapy in BCG-treated high-risk NMIBC with FGFR alterationsClinical trial · Phase IIIBladderJanssen-Cilag
MK-2870Intravesical sacituzumab tirumotecan (sac-TMT) in intermediate-risk NMIBCMK-2870-027Clinical trial · Phase I/IIBladderMerck Sharp & DohmeBernardo Herrera Imbroda
MK-3120-003Intravesical MK-3120 in high-risk NMIBC, BCG-naïve or BCG-exposedClinical trial · Phase I/IIBladderMerck Sharp & Dohme
POTOMACDurvalumab plus BCG versus BCG alone in BCG-naïve high-risk NMIBCD419JC00001Clinical trial · Phase IIIBladderAstraZenecaBernardo Herrera Imbroda
ONCOFID-P-BIntravesical paclitaxel–hyaluronic acid conjugate in BCG-unresponsive bladder carcinoma in situClinical trial · Phase IIIBladderFidia FarmaceuticiFelipe Sáez Barranquero
Intravesical eciskafusp alfa with BCG in BCG-unresponsive high-risk NMIBCBP45381Clinical trial · Phase I/IIBladderRoche FarmaBernardo Herrera Imbroda
UTOPIAUGN-103 in low-grade intermediate-risk non-muscle-invasive bladder cancerClinical trial · Phase IIIBladderUroGen PharmaFelipe Sáez Barranquero
Nivolumab with or without other agents, with or without BCG, in BCG-unresponsive high-risk NMIBCCA209-9UTClinical trial · Phase IIBladderBristol Myers Squibb
Pilot study of the biological effects of vitamin D in patients with resectable urothelial carcinomaClinical trial · Phase IVBladder Upper urinary tractIGTP (Germans Trias i Pujol)Bernardo Herrera Imbroda
URO-901-3005Clinical trialOther
DAROLObservational study of darolutamide in non-metastatic castration-resistant prostate cancerObservationalProstateBayer HispaniaBernardo Herrera Imbroda
PROHNOSRegistry of epidemiology, treatment patterns and real-world outcomes of metastatic hormone-sensitive prostate cancer in SpainObservationalProstate
ROADReal-world outcomes of darolutamide and ADT, with or without docetaxel, in metastatic hormone-sensitive prostate cancerObservationalProstate
RECAPSpanish Prostate Cancer Registry: radiotherapy treatment in routine clinical practiceObservationalProstateSociedad Española de Oncología RadioterápicaAna María Otero Romero
PARASECTreatment patterns and long-term follow-up of prostate cancer patients who received darolutamide in the ARAMIS trialObservationalProstateApices SolucionesJuan Andrés Cantero Mellado
ArtemisPROClinical outcomes in metastatic hormone-sensitive prostate cancer treated with ADT plus apalutamide or enzalutamide in routine practiceObservationalProstateJanssen-CilagDavid Hernández Alcaraz
PINNOCAVOrganisational innovation and personalised medicine platform to optimise the care pathway of patients with bladder cancerObservationalBladder
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