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A randomized, non-comparative, phase II multicentric trial on short-term darolutamide (ODM-201) concomitant to radiation therapy for patients with unfavorable intermediate-risk prostate cancer: DARIUS (AFU-GETUG P15)

dc.rights.licenseopenen_US
dc.contributor.authorROUBAUD, Guilhem
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBELLERA, Carine
dc.contributor.authorSELLAN-ALBERT, Sabrina
dc.contributor.authorCABART, Mathilde
dc.contributor.authorTEYSSONNEAU, Diego
dc.contributor.authorVUONG, Nam-Son
dc.contributor.authorPOIGNIE, Ludivine
dc.contributor.authorBENZIANE-OUARITINI, Nicolas
dc.contributor.authorSARGOS, Paul
dc.date.accessioned2024-10-18T07:13:39Z
dc.date.available2024-10-18T07:13:39Z
dc.date.issued2024-02-01
dc.date.conference2024-01-25
dc.identifier.issn0732-183Xen_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/202570
dc.description.abstractEnBackground: Androgen Deprivation Therapy (ADT) with external beam radiation therapy (EBRT) is a standard of care for patients (pts) with unfavorable intermediate-risk prostate cancer (Pca). However, ADT generates side effects with 30% decrease of quality of life (QoL). Enzalutamide (E) and Darolutamide (D) combined with ADT offer an overall survival benefit in advanced Pca. Without ADT, E avoid most of the deleterious effects of ADT. In a population of pts with intermediate risk Pca, 92% achieved PSA values , 0.1 ng/ml at the end of a treatment with EBRT and E alone.1 In pre-clinical models treated with D alone, testosterone (T) level remained normal.2 Such side effects related to T loss and to peripheral aromatization of T might be decreased with D alone. We assume that a combination of D given 6 months with EBRT in the treatment of unfavorable intermediate risk Pca is efficient and safe, without consequences on QoL. Methods: DARIUS is a national, multi-center, non-comparative randomized phase II prospective study (NCT05346848). The primary objective is to assess antitumor activity of D given 6 months with EBRT in pts with unfavorable intermediate risk Pca, using a biological response defined as PSA #0.1ng/ml, 6 months after randomization. D 6 months + EBRT and ADT 6 months + EBRT are offered in experimental and standard arm respectively. Randomization is 2:1. Regarding the experimental arm, given that E used alone achieved a 49% 6-month biological response rate in a hormone-sensible Pca pts,3 the association D+ EBRT will be considered useful if it can increase this rate to at least 70%. Using a single-stage design, standard response rate (P0) is 50% and alternative hypothesis P1 is 70% (one-sided 5% type I error rate, 80% power). Following one-stage A’Hern design, 37 and 19 pts are required in the experimental and standard arm, respectively. Adding 10% of non-eligible/assessable pts, the total number is 62. Enrollment have already begun and 5 pts have been enrolled. Inclusion criteria are: PS ECOG # 2; histological diagnosis of Pca, without metastasis (on Pelvic MRI AND thoraco-abdomino-pelvic contrast-enhanced CT-Scan AND Bone Scintigraphy); with unfavorable intermediate risk Pca diagnosis (NCCN Guidelines): 1- either Gleason = 7 (4+3) OR, 2-$ 50% of the core of biopsies positive for adenocarcinoma OR, 3- two or three of the following criteria (PSA value between 10-20 ng/ml, Gleason 7 (3+4) or 6, T2b (clinical or radiological)). Pts with T3a extension on MRI can be included if Gleason score is 6 and PSA , 20. Secondary objectives are biochemical Progression Free Survival, MFS, DFS, Pca-specific survival, Time to T recovery, safety, QoL and bone mineral density. Predictive factors will be investigated using Radiomics and DECIPHER. 1. Lara Front Oncol 2022. 2. Molainen Sci Rep 2015. 3. Tombal Lancet Oncol 2014. Clinical trial information: NCT05346848. Research Sponsor: None.
dc.language.isoENen_US
dc.publisherAmerican Society of Clinical Oncologyen_US
dc.title.enA randomized, non-comparative, phase II multicentric trial on short-term darolutamide (ODM-201) concomitant to radiation therapy for patients with unfavorable intermediate-risk prostate cancer: DARIUS (AFU-GETUG P15)
dc.typeCommunication dans un congrèsen_US
dc.identifier.doi10.1200/JCO.2024.42.4_suppl.TPS349en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
bordeaux.pageTPS349-TPS349en_US
bordeaux.volume42en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue4_Supplen_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.conference.title2024 ASCO Genitourinary Cancers Symposiumen_US
bordeaux.countryusen_US
bordeaux.title.proceedingMeeting Abstract: 2024 ASCO Genitourinary Cancers Symposiumen_US
bordeaux.teamEPICENE_BPHen_US
bordeaux.conference.citySan Franciscoen_US
hal.identifierhal-04742835
hal.version1
hal.date.transferred2024-10-18T07:13:41Z
hal.proceedingsouien_US
hal.conference.organizerAmerican Society of Clinical Oncology (ASCO)en_US
hal.conference.end2024-01-27
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
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