PROSENZA: Prospective Multi-Centre Study of Prognostic Factors in mCRPC Patients Treated With Enzalutamide.

NCT02922218 | Unknown

• 2 other identifiers: IBIMA-CNIO-CP-01-2016CNI-ENZ-2016-01
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 26

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

Conditions

Advanced Prostate Cancer; Castration Resistant; Enzalutamide

Keywords

metastatic Castration Resistant Prostate Cancer; Enzalutamide; Biomarkers

Outcome Measures

Primary Outcomes (1)

• To assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients

  Initially 48 months, currently 60 months

Secondary Outcomes (4)

• To analyze the correlation between biochemical and/or radiological response with AR-V7 expression and/or AR amplification in mCRPC patients treated with Enzalutamide.

  Initially 48 months, currently 60 months

• To assess AR-V7 expression and/or AR amplification changes before and after enzalutamide treatment

  Initially 48 months, currently 60 months

• 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

  Initially 48 months, currently 60 months

• To validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these patients

  Initially 48 months, currently 60 months

Other Outcomes (2)

• 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

  Initially 48 months, currently 60 months

• To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients

  Initially 48 months, currently 60 months

Study Arms (1)

Enzalutamide

Enzalutamide 160 mg/day c/24h

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

metastatic Castration-Resitant Prostate Cancer patients

You may qualify if:

• Male age ≥ 18 years
• Histologically confirmed adenocarcinoma 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Nacional de Investigaciones Oncologicas CARLOS III: lead
• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: collaborator

Study Sites (26)

Hospital Arquitecto Marcide

Ferrol, A Coruña, 15405, Spain

Location

Hospital Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

ICO L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Althaia Manresa

Manresa, Barcelona, 08243, Spain

Location

Hospital de Especialidades de Jerez de la Frontera

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Hospital Costa del Sol

Marbella, Málaga, 29603, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, 38320, Spain

Location

Fundacion Centro Oncologico de Galicia

A Coruña, 15009, Spain

Location

Hospital Universitario Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital de Burgos

Burgos, 09006, Spain

Location

Hospital de Ciudad Real

Ciudad Real, 13005, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Universitario de Guadalajara

Guadalajara, 19002, Spain

Location

Hospital Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas

Madrid, 28029, Spain

Location

Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Centro Integral Oncologico Clara Campal

Madrid, 28050, Spain

Location

Hospital Regional Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Morales Messeguer

Murcia, 30008, Spain

Location

Hospital Son Espases

Palma de Mallorca, 07120, Spain

Location

Complejo Hospitalario de Pontevedra

Pontevedra, 36002, Spain

Location

Hospital Universitario La Fe

Valencia, 46026, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and archival FFPE

Study Officials

• David Olmos, MD

  CNIO-Centro Nacionald e Investigaciones Oncológicas

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 4, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (26)