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Brief Title: Pembrolizumab, Carboplatin and Cabazitaxel in Aggressive Metastatic Castration Resistant Prostate Cancer (PEAPOD_FOS)
Official Title: A Phase 2 Clinical Trial of Pembrolizumab in Combination With Carboplatin and Cabazitaxel in Aggressive Variant Metastatic Castration Resistant Prostate Cancer
Study ID: NCT05563558
Brief Summary: It is a Phase 2 clinical trial of Pembrolizumab in combination with Carboplatin and Cabazitaxel in Aggressive Variant Metastatic Castration Resistant Prostate Cancer. It is divided into two parts: an induction period of 6 cycles of 3 weeks each cycle of Pembrolizumab+Cabazitaxel+Carboplatino and a maintenance phase of 15 cycles of 6 weeks each cycle of Pembrolizumab.
Detailed Description: Aggressive variant prostate cancer is a clinically defined subset of metastatic castration resistant prostate cancers characterized by the absence of response to AR targeted agents and neuroendocrine features. The treatments that are currently available are not effective and represent an unmet clinical need. This subgroup has been molecularly characterized and associate loss of key tumor suppressors, including TP53, PTEN and RB, and neuroendocrine features. Carboplatin and cabazitaxel have demonstrated promising activity in this scenario although virtually all patients succumb to the disease. Pembrolizumab has demonstrated activity in neuroendocrine tumors. In this trial will be evaluated the activity and safety of pembrolizumab in combination with the most active chemotherapy regiment available to date in aggressive variant prostate cancer, carboplatin plus cabazitaxel
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Hospital Universitario 12 de Octubre, Madrid, , Spain
Name: Enrique Gonzalez-Billalabeitia, Dr
Affiliation: Hospital Universitario 12 de Octubre, Madrid
Role: PRINCIPAL_INVESTIGATOR
Name: Teresa Alonso Gordoa, Dr
Affiliation: Hospital Universitario Ramón y Cajal
Role: PRINCIPAL_INVESTIGATOR
Name: Álvaro Pinto Marín, Dr
Affiliation: Hospital Universitario La Paz
Role: PRINCIPAL_INVESTIGATOR
Name: Ignacio Durán Martínez, Dr
Affiliation: Hospital Universitario Marqués de Valdecilla
Role: PRINCIPAL_INVESTIGATOR
Name: Begoña Mellado González, Dr
Affiliation: Hospital Clinic of Barcelona
Role: PRINCIPAL_INVESTIGATOR
Name: David Lorente Estellés, Dr
Affiliation: Hospital Provincial De Castellón
Role: PRINCIPAL_INVESTIGATOR
Name: Albert Font Pous, Dr
Affiliation: ICO- Badalona
Role: PRINCIPAL_INVESTIGATOR
Name: Sergio Vazquez Estévez, Dr
Affiliation: Hospital Lucus Augusti
Role: PRINCIPAL_INVESTIGATOR
Name: Javier Puente, Dr
Affiliation: Hospital San Carlos, Madrid
Role: PRINCIPAL_INVESTIGATOR