PROSENZA: Prospective Multi-Centre Study of Prognostic Factors in mCRPC Patients Treated With Enzalutamide.
NCT ID: NCT02922218
Last Updated: 2020-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
187 participants
OBSERVATIONAL
2016-06-30
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Enzalutamide
Enzalutamide 160 mg/day c/24h
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed adenocarcinoma of the prostate
3. ECOG Performance Status ≤ 2
4. Castration resistance must be documented with surgical or medical castration with serum testosterone \< 50 ng/mL (\< 2.0 nM).
5. Men diagnosed with at least one metastatic lesion on CT or bone scan.
6. Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria.
7. Patients who are candidates for standard of care treatment with enzalutamide 160 mg every 24 hours.
8. Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy.
9. Acceptable hematological, hepatic and renal functions.
Exclusion Criteria
2. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data
18 Years
99 Years
MALE
No
Sponsors
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Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
OTHER
Centro Nacional de Investigaciones Oncologicas CARLOS III
OTHER
Responsible Party
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Principal Investigators
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David Olmos, MD
Role: STUDY_CHAIR
CNIO-Centro Nacionald e Investigaciones Oncológicas
Locations
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Hospital Arquitecto Marcide
Ferrol, A Coruña, Spain
Hospital Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Althaia Manresa
Manresa, Barcelona, Spain
Hospital de Especialidades de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, Spain
Fundacion Centro Oncologico de Galicia
A Coruña, , Spain
Hospital Universitario Vall D'Hebron
Barcelona, , Spain
Hospital de Burgos
Burgos, , Spain
Hospital de Ciudad Real
Ciudad Real, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Universitario de Guadalajara
Guadalajara, , Spain
Hospital Universitario Gregorio Maranon
Madrid, , Spain
Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas
Madrid, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Centro Integral Oncologico Clara Campal
Madrid, , Spain
Hospital Regional Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Hospital Morales Messeguer
Murcia, , Spain
Hospital Son Espases
Palma de Mallorca, , Spain
Complejo Hospitalario de Pontevedra
Pontevedra, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Countries
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Other Identifiers
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CNI-ENZ-2016-01
Identifier Type: OTHER
Identifier Source: secondary_id
IBIMA-CNIO-CP-01-2016
Identifier Type: -
Identifier Source: org_study_id
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