Prospective Multi-Centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Enzalutamide.
Condition: Advanced Prostate Cancer, Castration Resistant, Enzalutamide
Purpose: PROSENZA is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with enzalutamide
Study Type: Observational
Clinical Trials Identifier NCT 8-digits: NCT02922218
Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III
Primary Outcome Measures:
- Measure: To assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients
- Time Frame: Initially 48 months, currently 60 months
- Safety Issue:
Secondary Outcome Measures:
- Measure: To analyze the correlation between biochemical and/or radiological response with AR-V7 expression and/or AR amplification in mCRPC patients treated with Enzalutamide.
- Time Frame: Initially 48 months, currently 60 months
- Safety Issue:
- Measure: To assess AR-V7 expression and/or AR amplification changes before and after enzalutamide treatment
- Time Frame: Initially 48 months, currently 60 months
- Safety Issue:
- Measure: To explore the correlation between AR-V7 expression and AR amplification with other biomarkers as testosterone serum levels, PTEN loss or TMPRSS-ERG fusions in mCRPC patients treated with Enzalutamide
- Time Frame: Initially 48 months, currently 60 months
- Safety Issue:
- Measure: To validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these patients
- Time Frame: Initially 48 months, currently 60 months
- Safety Issue:
Estimated Enrollment: 187
Study Start Date: June 2016
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Eligibility:
- Age: minimum 18 Years maximum 99 Years
- Gender: Male
Inclusion Criteria:
- Male age ≥ 18 years
- Histologically confirmed adenocarcinome of the prostate
- ECOG Performance Status ≤ 2
- Castration resistance must be documented with surgical or medical castration with serum testosterone < 50 ng/mL (< 2.0 nM).
- Men diagnosed with at least one metastatic lesion on CT or bone scan.
- Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria.
- Patients who are candidates for standard of care treatment with enzalutamide 160 mg every 24 hours.
- Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy.
- Acceptable hematological, hepatic and renal functions.
Exclusion Criteria:
- Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas.
- 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
Contact:
- David Olmos, MD
- 34 91 732 8000 Ext. 2950
Locations:
- Hospital Arquitecto Marcide
- Ferrol A Coruña 15405 Spain
- Hospital Universitario de Santiago
- Santiago de Compostela A Coruña 15706 Spain
- ICO L’Hospitalet
- L’Hospitalet de Llobregat Barcelona 08907 Spain
- Hospital Althaia Manresa
- Manresa Barcelona 08243 Spain
- Hospital de Especialidades de Jerez de la Frontera
- Jerez de la Frontera Cádiz 11407 Spain
- Hospital Costa del Sol
- Marbella Málaga 29603 Spain
- Complejo Hospitalario de Navarra
- Pamplona Navarra 31008 Spain
- Hospital Universitario de Canarias
- La Laguna Tenerife 38320 Spain
- Fundacion Centro Oncologico de Galicia
- A Coruna 15009 Spain
- Hospital Universitario Vall D’Hebron
- Barcelona 08035 Spain
- Hospital de Burgos
- Burgos 09006 Spain
- Hospital de Ciudad Real
- Ciudad Real 13005 Spain
- Hospital Universitario Reina Sofia
- Cordoba 14004 Spain
- Hospital Universitario Virgen de las Nieves
- Granada 18014 Spain
- Hospital Universitario de Guadalajara
- Guadalajara 19002 Spain
- Hospital Universitario Gregorio Maranon
- Madrid 28007 Spain
- Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas
- Madrid 28029 Spain
- Hospital Universitario Clinico San Carlos
- Madrid 28040 Spain
- Hospital Universitario 12 de Octubre
- Madrid 28041 Spain
- Centro Integral Oncologico Clara Campal
- Madrid 28050 Spain
- Hospital Regional Universitario Virgen de la Victoria
- Malaga 29010 Spain
- Hospital Morales Messeguer
- Murcia 30008 Spain
- Hospital Virgen de la Victoria
- Málaga 29010 Spain
- Hospital Son Espases
- Palma de Mallorca 07120 Spain
- Complejo Hospitalario de Pontevedra
- Pontevedra 36002 Spain
- Hospital Universitario La Fe
- Valencia 46026 Spain
View trial on ClinicalTrials.gov