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Short-term Darolutamide (ODM-201) Concomitant to Radiation Therapy for Patients with Unfavorable Intermediate-risk Prostate Cancer: The Darius (AFU-GETUG P15) Phase 2 Trial Protocol

dc.rights.licenseopenen_US
dc.contributor.authorSARGOS, Paul
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBELLERA, Carine
dc.contributor.authorBENTAHILA, Rita
dc.contributor.authorGUERNI, Marie
dc.contributor.authorBENZIANE-OUARITINI, Nicolas
dc.contributor.authorTEYSSONNEAU, Diego
dc.contributor.authorVUONG, Nam-Son
dc.contributor.authorPLOUSSARD, Guillaume
dc.contributor.authorROUPRET, Morgan
dc.contributor.authorROUBAUD, Guilhem
dc.date.accessioned2024-06-27T08:38:11Z
dc.date.available2024-06-27T08:38:11Z
dc.date.issued2024-05-15
dc.identifier.issn2588-9311en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/200668
dc.description.abstractEnBACKGROUND: Combination of androgen deprivation therapy (ADT) with external beam radiation therapy (EBRT) is a standard of care for patients with intermediate-risk prostate cancer (PCa). However, 6 months of ADT generates multiple side effects impacting quality of life (QoL). Darolutamide (an androgen receptor targeting agent [ARTA]) is associated with low blood-brain barrier penetrance and less drug-drug interaction. OBJECTIVE: To assess the efficacy of a combination of 6 months of darolutamide with EBRT to treat patients with unfavorable intermediate-risk PCa. DESIGN, SETTING, AND PARTICIPANTS: The DARIUS trial is a multicenter randomized non comparative phase 2 trial, randomizing the 6-months darolutamide + EBRT arm versus 6-months ADT + EBRT in patients with unfavorable intermediate-risk PCa. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint is a biological response defined as prostate-specific antigen ≤0.1 ng/ml at month six of darolutamide or ADT. The key secondary endpoints are biochemical recurrence-free survival, disease-free survival, safety, and QoL. Ancillary studies using radiomics and genomic classifier are planned. Sixty-two patients will be included. RESULTS AND LIMITATIONS: In this population of patients requiring ADT combined with EBRT, the use of an ARTA alone, such as darolutamide, may demonstrate antitumoral efficacy while minimizing toxicity and maintaining QoL. Limitations are mainly inherent to the open-label design of this study. CONCLUSIONS: Six months of darolutamide + EBRT compared with 6 months of ADT + EBRT may be efficient in terms of a biological response, avoiding toxicity and altered QoL attributable to ADT in patients with unfavorable intermediate-risk PCa. PATIENT SUMMARY: The ongoing DARIUS clinical trial assesses short-term (6 months) darolutamide treatment in association with external beam radiation therapy in men with localized prostate cancer. The trial investigates whether single-agent darolutamide can improve the biological response while maintaining a favorable tolerability profile.
dc.language.isoENen_US
dc.subject.enClinical trial
dc.subject.enDarolutamide
dc.subject.enHormonal therapy
dc.subject.enProstate cancer
dc.subject.enRadiation therapy
dc.title.enShort-term Darolutamide (ODM-201) Concomitant to Radiation Therapy for Patients with Unfavorable Intermediate-risk Prostate Cancer: The Darius (AFU-GETUG P15) Phase 2 Trial Protocol
dc.title.alternativeEur Urol Oncolen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/j.euo.2024.04.023en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed38755095en_US
bordeaux.journalEuropean Urology Oncologyen_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamEPICENE_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-04626882
hal.version1
hal.date.transferred2024-06-27T08:38:13Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=European%20Urology%20Oncology&rft.date=2024-05-15&rft.eissn=2588-9311&rft.issn=2588-9311&rft.au=SARGOS,%20Paul&BELLERA,%20Carine&BENTAHILA,%20Rita&GUERNI,%20Marie&BENZIANE-OUARITINI,%20Nicolas&rft.genre=article


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