Clinical trial NCT02922218: PROSENZA: Prospective Multi-Centre Study of Prognostic Factors in mCRPC Patients Treated With Enzalutamide.
Official title: Prospective Multi-Centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Enzalutamide.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Prostate Cancer
Castration Resistant
Enzalutamide
Keywords: metastatic Castration Resistant Prostate Cancer
Enzalutamide
Biomarkers
Lead sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III
Sponsor class: OTHER
Collaborators: name: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
First posted: 2016-10-04
Enrollment: 187
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: metastatic Castration-Resitant Prostate Cancer patients

Brief summary: 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

Detailed description: This study is a prospective biomarker study of patients with mCRPC undergoing treatment with enzalutamide as standard of care treatment. The participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study.

Eligibility criteria: Inclusion Criteria:

1. Male age ≥ 18 years
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:

1. 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.
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

Primary outcomes:
measure: To assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients
timeFrame: Initially 48 months, currently 60 months
Secondary outcomes:
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.
timeFrame: Initially 48 months, currently 60 months
measure: To assess AR-V7 expression and/or AR amplification changes before and after enzalutamide treatment
timeFrame: Initially 48 months, currently 60 months
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
timeFrame: Initially 48 months, currently 60 months
measure: To validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these patients
timeFrame: Initially 48 months, currently 60 months
Other outcomes:
measure: To validate the independent prognostic value of the gene-expression signature from peripheral blood described by Olmos et al (Lancet Oncol 2012) on overall survival of mCRPC patients
timeFrame: Initially 48 months, currently 60 months
measure: To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients
timeFrame: Initially 48 months, currently 60 months
Locations:
city: Ferrol
country: Spain
facility: Hospital Arquitecto Marcide
state: A Coruña
city: Santiago de Compostela
country: Spain
facility: Hospital Universitario de Santiago
state: A Coruña
city: L'Hospitalet de Llobregat
country: Spain
facility: ICO L'Hospitalet
state: Barcelona
city: Manresa
country: Spain
facility: Hospital Althaia Manresa
state: Barcelona
city: Jerez de la Frontera
country: Spain
facility: Hospital de Especialidades de Jerez de la Frontera
state: Cádiz
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: A Coruna
country: Spain
facility: Fundacion Centro Oncologico de Galicia
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D'Hebron
city: Burgos
country: Spain
facility: Hospital de Burgos
city: Ciudad Real
country: Spain
facility: Hospital de Ciudad Real
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal
city: Malaga
country: Spain
facility: Hospital Regional Universitario Virgen de la Victoria
city: Murcia
country: Spain
facility: Hospital Morales Messeguer
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
Study officials:
affiliation: CNIO-Centro Nacionald e Investigaciones Oncológicas
name: David Olmos, MD
role: STUDY_CHAIR
References: