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- Estudio abierto, multicéntrico y de un solo grupo, para evaluar la eficacia y la seguridad de una formulación semestral de triptorelina administrada por vía subcutánea a participantes con cáncer de próstata localmente avanzado y/o metastásico, previamente tratados y sometidos a castración farmacológica con un análogo de la GnRH.
Estudio abierto, multicéntrico y de un solo grupo, para evaluar la eficacia y la seguridad de una formulación semestral de triptorelina administrada por vía subcutánea a participantes con cáncer de próstata localmente avanzado y/o metastásico, previamente tratados y sometidos a castración farmacológica con un análogo de la GnRH.
Datos básicos
- Protocolo:
- D-FR-52014-245
- EUDRACT:
- 2021-005719-29
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Año de incio:
- 2022
- Año de finalización:
Objetivos del proyecto
Objetivo Principal: Evaluar la eficacia de la formulación semestral de triptorelina embonato 22,5 mg administrada por vía subcutánea para mantener los niveles de castración de testosterona sérica en participantes con cáncer de próstata avanzado, previamente tratados y sometidos a castración farmacológica con un análogo de la GnRH. Objetivos Secundarios: - Evaluar la eficacia de la formulación semestral de triptorelina embonato 22,5 mg administrada por vía subcutánea en cuanto a la castración; - Evaluar la eficacia de la formulación semestral de triptorelina embonato 22,5 mg administrada por vía subcutánea a juzgar por niveles de testosterona <0,694 nmol/L (20 ng/dl); - Demostrar el efecto de la formulación semestral de triptorelina embonato 22,5 mg administrada por vía subcutánea en cuanto a la supresión de la reagudización tras la administración de la segunda dosis; - Demostrar el efecto de la formulación semestral de triptorelina embonato 22,5 mg administrada por vía subcutánea en cuanto al mantenimiento del PSA; - Demostrar el perfil de seguridad de la formulación semestral de triptorelina embonato 22,5 mg administrada por vía subcutánea
Documentos
- No hay documentos
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Resultados del Ensayo Clínico
[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
[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
[Translated article] New challenges in advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2024.05.001. 2024
[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
A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.
Zozaya, Neboa; (...); Verde, Luis
Article. 10.1017/S0266462322000459. 2022
A New Clinical Instrument for Estimating the Ambulatory Status after Irradiation for Malignant Spinal Cord Compression
Rades, Dirk; (...); Schild, Steven E.
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González-San Segundo C; (...); Couñago F
Article. 10.1111/bju.16484. 2024
A Smart Digital Health Platform to Enable Monitoring of Quality of Life and Frailty in Older Patients with Cancer: A Mixed-Methods, Feasibility Study Protocol.
Papachristou, Nikolaos; (...); Bamidis, Panagiotis D.
Article. 10.1016/j.soncn.2023.151437. 2023
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Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
Brachytherapy for targeting the immune system in cervical cancer patients.
Linares I; (...); Pujol M
Article. 10.1186/s12865-023-00559-y. 2023
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
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
Correction to: Radiation therapy for vulvar cancer: consensus guidelines of the GINECOR working group of the Spanish Society of Radiation Oncology. Part 1: clinical recommendations.
Cordoba Largo S; (...); Sánchez Belda M
Correction. 10.1007/s12094-023-03183-9. 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
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
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
Encorafenib and binimetinib followed by radiotherapy for patients with BRAFV600-mutant melanoma and brain metastases (E-BRAIN/GEM1802 phase II study).
Marquez-Rodas, Ivan; (...); Berrocal, Alfonso
Article. 10.1093/neuonc/noae116. 2024
Endothelial Biomarkers Are Superior to Classic Inflammatory Biomarkers in Community-Acquired Pneumonia.
González-Jiménez P; (...); Méndez R
Article. 10.3390/biomedicines12102413. 2024
Endothelial Damage, Neutrophil Extracellular Traps and Platelet Activation in COVID-19 vs. Community-Acquired Pneumonia: A Case-Control Study.
González-Jiménez P; (...); Menéndez R
Article. 10.3390/ijms241713194. 2023
Evaluating the complement C1q levels in serum and cerebrospinal fluid in multiple sclerosis patients: Could it serve as a valuable marker in clinical practice?
Tortosa-Carreres J; (...); Pérez-Miralles FC
Article. 10.1016/j.jneuroim.2024.578428. 2024
Evaluation of EMBARK criteria patients. Real-world data on prostate cancer biochemical recurrence
Centelles Hidalgo, Elena; (...); Lopez-Campos, Fernando
Meeting Abstract. 2024
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
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
Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.
Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula
Article. 10.3390/antibiotics13080706. 2024
LATTICE radiotherapy: A one institution experience
Solero, I.; (...); Conde, A.
Meeting Abstract. 2023
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
Multi-Institutional Analysis of Metastasis Directed Therapy with or without Androgen Deprivation Therapy in Oligometastatic Castration Sensitive Prostate Cancer.
Sutera, P.; (...); Sweeney, C.
Article. 10.1016/j.ijrobp.2023.06.1620. 2023
Multi-institutional Analysis of Metastasis-directed Therapy with or Without Androgen Deprivation Therapy in Oligometastatic Castration-sensitive Prostate Cancer.
Deek MP; (...); Sweeney C
Article. 10.1016/j.euo.2024.03.010. 2024
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
Neutrophil Extracellular Traps and Platelet Activation for Identifying Severe Episodes and Clinical Trajectories in COVID-19
González-Jiménez P; (...); Menéndez R
Article. 10.3390/ijms24076690. 2023
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
Node Oligorecurrence in Prostate Cancer: A Challenge.
Zapatero A; (...); Aldave D
Article. 10.3390/cancers15164159. 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
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
Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Review. 10.3390/biology12091159. 2023
OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT
Flores-Moreno, S.; (...); Gil, A.
Meeting Abstract. 2024
Oxygen therapy at 1.4 atmospheres in radiation-induced cystitis and proctitis
Prato Carreno, O. A.; (...); Conde Moreno, A. J.
Meeting Abstract. 2023
PEACE V-Salvage Treatment of oligorecurrent nodal prostate cancer metastases (STORM): 24-months toxicity results of a randomized phase II trial
Zilli, T.; (...); Ost, P.
Meeting Abstract. 2024
PEACE V-Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM): Acute Toxicity of a Randomized Phase 2 Trial.
Ost, Piet; (...); Zilli, Thomas
Article. 10.1016/j.euo.2023.09.007. 2023
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
Predictive potential of serum and cerebrospinal fluid biomarkers for disease activity in treated multiple sclerosis patients.
Tortosa-Carreres J; (...); Pérez-Miralles FC
Article. 10.1016/j.msard.2024.105734. 2024
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
Radiation therapy for vulvar cancer: consensus guidelines of the GINECOR working group of the Spanish Society of Radiation Oncology. Part 1: clinical recommendations.
Cordoba Largo S; (...); Sánchez Belda M
Article. 10.1007/s12094-023-03095-8. 2023
Radiation therapy for vulvar cancer: consensus technical guidelines of the GINECOR working group of the Spanish Society of Radiation Oncology. Part 2: radiotherapy recommendations.
Cordoba Largo, Sofia; (...); Sanchez Belda M
Article. 10.1007/s12094-023-03101-z. 2023
Real-world evidence analysis of early-stage prostate cancer using natural language processing
Juarez, Alvaro; (...); Alcaraz, Antonio
Meeting Abstract. 2023
Re-irradiation in NSCLC High-dose RT: Control, Survival and Toxicity
Germain, J.; (...); Conde, A.
Meeting Abstract. 2023
RT after Encorafenib and Binimetinib on BRAF mutated melanoma brain metastases. GEM1802-Phase II
Alvarez, A.; (...); Marquez Rodas, I.
Meeting Abstract. 2023
Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM)
Ost, Piet; (...); Moon, Daniel
Meeting Abstract. 2024
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 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
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
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