ESTUDIO DE FASE 3, ALEATORIZADO, A DOBLE CIEGO, CONTROLADO CON PLACEBO, DE ACETATO DE ABIRATERONA (CB7630) MAS PREDNISONA EN PACIENTES CON CANCER DE PROSTATA METASTASICO RESISTENTE A LA CASTRACION EN LOS QUE HA FRACASADO LA QUIMIOTERAPIA BASADA EN DOCETAX EL

Datos básicos

Código:
COU-AA-301
Protocolo:
COU-AA-301
EUDRACT:
2007-005837-13
NCT:
Centro:
Dotación:
Año de incio:
Año de finalización:
2013
ENSAYO CLÍNICO

Documentos

  • No hay documentos

Participantes

Grupos

Financiadores - Promotores

COUGAR BIOTECHNOLOGY, INC

Resultados del Ensayo Clínico


[ 177 Lu]Lu-DOTA-TATE and [ 131 I]MIBG Phenotypic Imaging-Based Therapy in Metastatic/Inoperable Pheochromocytomas and Paragangliomas: Comparative Results in a Single Center.

Prado-Wohlwend, Stefan; (...); Merino-Torres, Juan Francisco

Article. 10.3389/fendo.2022.778322. 2022

  • Open Access.

[Translated article] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence

Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda

Editorial Material. 10.1016/j.farma.2024.08.009. 2024

  • Open Access.

[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services

Company Albir MJ, Andrés JLP, Solsona MDE

Article. 10.1016/j.farma.2023.10.004. 2024

  • Open Access.

[Translated article] New challenges in advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2024.05.001. 2024

  • Open Access.

[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.

Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.12.007. 2025


[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.

Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.09.006. 2024

  • Open Access.

177Lu-DOTATATE (PRRT) in the treatment of patients with gastroenteropancreatic neuroendocrine tumors (GEPNETs) versus other tumors

Jimenez-Fonseca, P.; (...); Carmona-Bayonas, A.

Meeting Abstract. 2022


177-Lu-DOTATATE in 382 patients with somatostatin receptor-positive advanced tumors: Real-world data from the SEPTRALU registry

Casanovas M, Mitjavila; (...); Carmona-Bayonas, A.

Meeting Abstract. 2022


177Lu-DOTATATE in advanced neuroendocrine neoplasms of different locations - Data from 552 cases in the SEPTRALU registry

Mitjavila Casanovas, M.; (...); Jimenez-Fonseca, P.

Meeting Abstract. 2023


A multicriteria decision analysis (MCDA) applied to three long-term prophylactic treatments for hereditary angioedema in Spain

Zozaya, Neboa; (...); Hidalgo-Vega, Alvaro

Article. 10.33393/grhta.2022.2333. 2022

  • Open Access.

A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.

Zozaya, Neboa; (...); Verde, Luis

Article. 10.1017/S0266462322000459. 2022

  • Open Access.

Alternatives of the pelvic sentinel lymph node migration pathway in early ovarian cancer: the simplest the best.

Lago, Victor; (...); Domingo, Santiago

Article. 10.1136/ijgc-2023-004912. 2023

  • Open Access.

Analysis of chemical contamination by hazardous drugs with BD HD Check(R) system in a tertiary hospital

Valero García S; (...); Poveda Andrés JL

Article. 10.1177/10781552211038518. 2021


Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).

Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ

Letter. 10.1111/jdv.19432. 2023

  • Open Access.

Baricitinib against severe COVID-19: effectiveness and safety in hospitalised pretreated patients.

Iglesias Gómez R; (...); Poveda Andrés JL

Article. 10.1136/ejhpharm-2021-002741. 2021

  • Open Access.

BCAS1 defines a heterogeneous cell population in diffuse gliomas.

Morales-Gallel, Raquel; (...); Garcia-Verdugo, Jose Manuel

Article. 10.18632/oncotarget.28553. 2024

  • Open Access.

Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study.

Fernandez Rivera C; (...); Hernandez D

Article. 10.1111/ctr.14550. 2022

  • Open Access.

Clinical benefits of a Bayesian model for plasma-derived factor VIII/VWF after one year of pharmacokinetic-guided prophylaxis in severe/moderate hemophilia A patients

Megias-Vericat, JE; (...); Poveda, JL

Article. 10.1016/j.thromres.2021.07.009. 2021


Clinical experience of whole body and tumour dosimetry of 131-I-mIBG treatment for pediatric patients

Espallardo, I. Torres; (...); Prado-Wohlwend, S.

Meeting Abstract. 2023


ComBat harmonization in different PET imaging scenarios

Gandia-Ferrero, M.; (...); Marti-Bonmati, L.

Meeting Abstract. 2023


Comparison of 3D dosimetry methods in hepatic radioembolisation with Y-90 microspheres

Carrasco Vela, N.; (...); Torres-Espallardo, I.

Meeting Abstract. 2021

  • Open Access.

Comparison of protocols with respiratory-gated (4D) motion compensation in PET/CT: open-source package for quantification of phantom image quality.

Martinez-Movilla, Andrea; (...); Carles, Montserrat

Article. 10.1186/s40658-022-00509-4. 2022

  • Open Access.

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano JB; (...); Soto-Ortega I

Article. 10.1016/j.farma.2023.01.003. 2023

  • Open Access.

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada

Article. 10.1016/j.farma.2023.04.002. 2023


Correlation Between Clinical Characteristics And Effective Washout Time In Patients Treated With High Radioiodine Activities

Guerrero Calatayud, C.; (...); Bello Arques, P.

Meeting Abstract. 2023


COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN

Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.

Meeting Abstract. 2024


Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.

Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL

Editorial Material. 10.1016/j.farma.2024.08.001. 2024

  • Open Access.

Design and rationale for a real-world prospective, multicenter registry of myocardial revascularization failure and secondary revascularization: The REVASEC study.

Salinas P; (...); Escaned J

Article. 10.1016/j.carrev.2021.11.015. 2021


Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.

Abad, Maria Reyes; (...); Gil, Alicia

Article. 10.33393/grhta.2024.3041. 2024

  • Open Access.

Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis

Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther

Article. 10.1002/jvc2.275. 2024

  • Open Access.

Do SPECT CT and sentinel node tecnhique increase the diagnosis of metastasic disease in prostate cancer?

Perez Ardavin, J.; (...); Vera-Donoso, C. D.

Meeting Abstract. 2022


Effectiveness of Caplacizumab Nanobody in Acquired Thrombotic Thrombocytopenic Purpura Refractory to Conventional Treatment

Palanques-Pastor T; (...); Poveda Andrés JL

Article. 10.1159/000517813. 2021


Efficacy and Safety of 177Lu-DOTATATE in Lung Neuroendocrine Tumors: A multicenter study

Mitjavila Casanovas, M.; (...); Jimenez-Fonseca, P.

Meeting Abstract. 2023


Efficacy of [177Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study.

Mitjavila, Mercedes; (...); Carmona-Bayonas, Alberto

Article. 10.1007/s00259-023-06166-8. 2023

  • Open Access.

Evaluation of 177Lu-DOTATATE treatment in patients with metastasic or unresectable paragangliomas and pheochromocytomas

Canon Sanchez, J.; (...); Utrera Costero, A.

Meeting Abstract. 2021


Fetal exposure to tofacitinib during the first trimester: A healthy newborn case report

Fernandez-Sanchez, M; (...); Poveda-Andres, JL

Article. 10.1002/bdr2.1942. 2021


Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.

Plaza J; (...); Moret-Tatay I

Article. 10.3390/ijms25073717. 2024

  • Open Access.

Guide to Good Humanization Practices in Patients with Rare Diseases. who vadis

Poveda Andres, Jose Luis

Editorial Material. 2022


Healthcare Resource Utilization among Patients between 60-75 Years with Secondary Acute Myeloid Leukemia Receiving Intensive Chemotherapy Induction: A Spanish Retrospective Observational Study

Solana-Altabella, Antonio; (...); Martinez-Cuadron, David

Article. 10.3390/cancers14081921. 2022

  • Open Access.

High incidence of pulmonary thromboembolism in hospitalized SARS-CoV-2 infected patients despite thrombo-prophylaxis.

El-Qutob D; (...); Carrera-Hueso FJ

Article. 10.1016/j.hrtlng.2022.02.003. 2022

  • Open Access.

Hospital pharmacy initiatives for improving the management of patients with congenital coagulopathies

Bruno Montoro-Ronsano, Jose; (...); Alberto Vella, Vincenzo

Article. 10.7399/fh.11729. 2022


Hospitalization budget impact during the COVID-19 pandemic in Spain.

Carrera-Hueso, F. J.; (...); Crespo-Palomo, C.

Article. 10.1186/s13561-021-00340-0. 2021

  • Open Access.

How can artificial intelligence optimize value-based contracting?

Poveda, Jose Luis; (...); Medrano, Ignacio H.

Letter. 10.1186/s40545-022-00475-3. 2022

  • Open Access.

Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.

Pozo-Rosich P; (...); Irimia P

Article. 10.1186/s10194-024-01747-w. 2024

  • Open Access.

Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.

Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula

Article. 10.3390/antibiotics13080706. 2024

  • Open Access.

Less is more: Usefulness of the sentinel node technique in radical prostatectomy

Perez Ardavin, J.; (...); Vera-Donoso, C. D.

Meeting Abstract. 2022


Local detection of microvessels in IDH-wildtype glioblastoma using relative cerebral blood volume: an imaging marker useful for astrocytoma grade 4 classification.

Álvarez-Torres MDM; (...); Garcia-Gomez, Juan Miguel

Article. 10.1186/s12885-021-09117-4. 2022

  • Open Access.

Lu-177-DOTATATE therapy in advanced pancreatic neuroendocrine tumors: data from 187 patients of the national registry SEPTRALU

Mitjavila-Casanovas, M.; (...); Jimenez-Fonseca, P.

Meeting Abstract. 2022


Lutetium177 in patients with stage IV neuroendocrine tumours of any origin. Data from 321 patients of the multicenter national registry

Mitjavila Casanovas, M.; (...); Jimenez-Fonseca, P.

Meeting Abstract. 2021


Management of flexible cavovarus foot in patients with Charcot-Marie-Tooth disease: midterm results.

Megías-Vericat JE; (...); Poveda-Andrés JL

Article. 2021

  • Open Access.

Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.

Vázquez Polo A; (...); Vázquez Costa JF

Article. 10.20960/nh.03946. 2022

  • Open Access.

Matching-Adjusted Indirect Comparison of Efficacy and Consumption of rVIII-SingleChain Versus Two Recombinant FVIII Products Used for Prophylactic Treatment of Adults/Adolescents with Severe Haemophilia A

Bonanad, S; (...); Santos, S

Article. 10.1007/s12325-021-01853-0. 2021

  • Open Access.

Medical imaging clinical trials unit: A professional need.

Penades-Blasco, Ana; (...); Marti-Bonmati, Luis

Article. 10.1016/j.ejrad.2021.110099. 2022

  • Open Access.

Metabolic Phenotyping in Prostate Cancer Using Multi-Omics Approaches.

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Article. 10.3390/cancers14030596. 2022

  • Open Access.

Multi-Omic Approaches to Breast Cancer Metabolic Phenotyping: Applications in Diagnosis, Prognosis, and the Development of Novel Treatments

Gomez-Cebrian, N; (...); Pineda-Lucena, A

Review. 10.3390/cancers13184544. 2021

  • Open Access.

National Survey of the SEFH-2019: portfolio of services, healthcare activity, teaching and research in Hospital Pharmacy Services in Spain (vol 45, pg 32, 2021)

Perez-Encinas, Montserrat; (...); Angel Calleja-Hernandez, Miguel

Correction. 10.7399/fh.11740. 2021

  • Open Access.

National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies

Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis

Meeting Abstract. 10.1182/blood-2022-169938. 2022

  • Open Access.

New challenges of advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2023.11.008. 2024

  • Open Access.

Non-traumatic spontaneous abdominal haemorrhage

Ballesta, M.; (...); Lerga, P. Estelles

Article. 10.1016/j.rx.2022.11.003. 2023


Non-traumatic spontaneous abdominal haemorrhage.

Ballesta M; (...); Estellés Lerga P

Article. 10.1016/j.rxeng.2022.11.004. 2023


Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus

Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis

Article. 10.1097/MD.0000000000032208. 2022

  • Open Access.

ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.

Poveda JL; (...); Badia X

Article. 10.1186/s13023-022-02610-4. 2023

  • Open Access.

Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Review. 10.3390/biology12091159. 2023

  • Open Access.

OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT

Flores-Moreno, S.; (...); Gil, A.

Meeting Abstract. 2024


Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol (vol 8, 372, 2020)

Garcia-Robles, Ana; (...); Aguar Carrascosa, Marta

Correction. 10.3389/fped.2021.834454. 2022

  • Open Access.

Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project

Morillo-Verdugo, R; (...); Diaz-Olmo, J

Article. 10.7399/fh.11719. 2021


Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project.

Morillo-Verdugo R; (...); Díaz-Olmo J

Article. 2021

  • Open Access.

Peptide Receptor Radionuclide Therapy with [(177)Lu]Lu-DOTA-TATE in Patients with Advanced GEP NENS: Present and Future Directions.

del Olmo-Garcia, Maria I.; (...); Merino-Torres, Juan F.

Article. 10.3390/cancers14030584. 2022

  • Open Access.

Peptide receptor radionuclide therapy with [(177)Lu]Lu-DOTA-TATE.

Prado-Wohlwend S; (...); Endocrinology Working Group of the SEMNIM

Article. 10.1016/j.remnie.2021.11.001. 2022


Peptide receptor radionuclide therapy with [Lu-177]Lu-DOTA-TATE

Prado-Wohlwend, S.; (...); SEMNIM

Article. 2022


Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.

Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis

Article. 10.3390/ijms26041760. 2025

  • Open Access.

Pharmacometabolomics by NMR in Oncology: A Systematic Review.

Gómez-Cebrián N; (...); Pineda-Lucena A

Article. 10.3390/ph14101015. 2021

  • Open Access.

Pharmacotherapeutic management of advanced therapy medicinal products

Luis Poveda-Andres, Jose; (...); Valero-Garcia, Silvia

Article. 10.7399/fh.13036. 2022


Prediction of patient progression-free survival with 177Lu-DOTATATE in clinical practice: NEPTUNESEPTRALU model for patient selection

Mitjavila Casanovas, M.; (...); Carmona-Bayonas, A.

Meeting Abstract. 2024


Preparation and administration of insulin infusions in neonatology: A national survey.

Garcia-Robles, Ana; (...); Aguar Carrascosa, Marta

Article. 10.1016/j.anpede.2020.06.015. 2021

  • Open Access.

Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services

Company Albir MJ, Poveda Andrés JL, Edo Solsona MD

Article. 10.1016/j.farma.2023.06.0131130. 2024

  • Open Access.

Prognostic factors in patients with advanced neuroendocrine neoplasia treated with radiopeptides (PRRT) - Data from the national registry SEPTRALU

Bello, P.; (...); Carmona-Bayonas, A.

Meeting Abstract. 2023


Proposal of a short acquisition protocol for 18F-DOPA imaging in brain tumors:preliminary results

Orrego, N.; (...); Bello-Arques, P.

Meeting Abstract. 2024


Radio theranostics in paragangliomas and pheochromocytomas

Wohlwend, S. Prado, Arques, P. Bello

Article. 10.1016/j.remn.2024.500017. 2024

  • Open Access.

Radio theranostics in paragangliomas and pheochromocytomas.

Wohlwend SP, Arques PB

Article. 10.1016/j.remnie.2024.500017. 2024

  • Open Access.

Radioembolization in patients with hepatocellular carcinoma: a series of 53 cases.

Olivan-Sasot, P; (...); Olivas-Arroyo, C

Article. 10.1016/j.rxeng.2021.03.001. 2023


Response to targeted radionuclide therapy with [131I]MIBG AND [177Lu]Lu-DOTA-TATE according to adrenal vs. extra-adrenal primary location in metastatic paragangliomas and pheochromocytomas: A systematic review.

Prado-Wohlwend, Stefan; (...); Merino-Torres JF

Article. 10.3389/fendo.2022.957172. 2022

  • Open Access.

Retreatment PRRT with 177Lu-DOTATATE in patients with progressive neuroendocrine neoplasm: Spanish clinical experience from national registry

Mitjavila Casanovas, M.; (...); Hernando, J.

Meeting Abstract. 2024


Same-day comparative protocol PET/CT-PET/MRI [68Ga]Ga-DOTA-TOC in paragangliomas and pheochromocytomas: an approach to personalized medicine.

Prado-Wohlwend, Stefan; (...); Merino-Torres, Juan Francisco

Article. 10.1186/s40644-023-00521-6. 2023

  • Open Access.

Sequential treatment of High-risk Neuroblastoma combining I-131 MIBG high-dose and Topotecan. First experience

Orrego, N.; (...); Bello-Arques, P.

Meeting Abstract. 2023


SMPTall man lettering application in medication information systems as a quality and safety strategy in hospital organization

Iglesias Gomez, Ruben; (...); Poveda Andres, Jose Luis

Article. 10.1111/jcpt.13703. 2022

  • Open Access.

Somatostatin and Somatostatin Receptors: From Signaling to Clinical Applications in Neuroendocrine Neoplasms.

Del Olmo-Garcia MI; (...); Merino-Torres JF

Article. 10.3390/biomedicines9121810. 2021

  • Open Access.

Systematic Review of Pharmacogenetics of ABC and SLC Transporter Genes in Acute Myeloid Leukemia

Megías-Vericat JE; (...); Montesinos P

Review. 10.3390/pharmaceutics14040878. 2022

  • Open Access.

The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity

Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar

Article. 10.1007/s00431-022-04628-z. 2022


The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.

Gil-Nagel A; (...); Gil A

Article. 10.1016/j.yebeh.2022.108711. 2022

  • Open Access.

The Role of Imaging Studies in Favor of Possible Cerebellar Multiple System Atrophy: A Case Study.

Utrera-Costero, Ana; (...); Bello-Arques, Pilar

Article. 10.1097/RLU.0000000000003767. 2021


The sentinel node with technetium-99m for prostate cancer. A safe and, mature new gold standard?

Perez-Ardavin J; (...); Vera-Donoso CD

Article. 10.23736/S1824-4785.22.03416-1. 2022


The value of F-18-FDG PET/CT in two cases of Primary Pericardial Mesothelioma

Utrera-Costero, Ana; (...); Bello-Arques, Pilar

Article. 10.1007/s12350-021-02690-y. 2021


The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).

Badia, Xavier; (...); Valles, Joan-Antoni

Article. 10.1186/s13023-024-03324-5. 2024

  • Open Access.

Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.

Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis

Article. 10.1136/ejhpharm-2024-004184. 2024


Update on iodine-refractory differentiated thyroid carcinoma

Casas, E. Abou Jokh; (...); Casas, J. A. Vallejo

Article. 10.1016/j.remn.2023.06.005. 2023


Update on iodine-refractory differentiated thyroid carcinoma.

Jokh Casas, E A; (...); Vallejo Casas, J A

Article. 10.1016/j.remnie.2023.07.003. 2023


VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA

Poveda, J. L.; (...); Lizan, L.

Meeting Abstract. 2023


Y-90 PET/MR imaging optimization with a Bayesian penalized likelihood reconstruction algorithm.

Calatayud-Jordan, Jose; (...); Torres-Espallardo, Irene

Article. 10.1007/s13246-024-01452-7. 2024

  • Open Access.

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