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Trial record 7 of 105 for:    mdv3100 | Recruiting, Not yet recruiting, Available Studies

PROSENZA: Prospective Multi-centre Study of Prognostic Factors in CRPC Treated With Enzalutamide (PROSENZA)

This study is currently recruiting participants.
Verified March 2017 by Centro Nacional de Investigaciones Oncologicas CARLOS III
Sponsor:
ClinicalTrials.gov Identifier:
NCT02922218
First Posted: October 4, 2016
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Information provided by (Responsible Party):
Centro Nacional de Investigaciones Oncologicas CARLOS III
  Purpose
Prospective Multi-centre Study of Prognostic Factors in Castration Resistant PROState Cancer Treated With Enzalutamide (PROSENZA).

Condition Intervention
Prostate Cancer Castration Resistant Enzalutamide Drug: Enzalutamide

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multi-centre Study of Prognostic Factors in Castration Resistant PROState Cancer Treated With Enzalutamide

Resource links provided by NLM:


Further study details as provided by Centro Nacional de Investigaciones Oncologicas CARLOS III:

Primary Outcome Measures:
  • prognostic value for global survival [ Time Frame: 48 months ]
    Independently validate the prognostic value for global survival of the expression signature in peripheral blood of nine genes characterised by Olmos et al. (Lancet Oncol., 2012) in patients with castration-resistant prostate cancer (CRPC) who are candidates for treatment with Enzalutamide


Secondary Outcome Measures:
  • response by detecting PSA [ Time Frame: 48 months ]
    Analyzing the correlation between the response by detecting PSA and AR-V7 and / or presence of amplification of the androgen receptor in peripheral blood in patients with CPRC candidates for treatment with ENZALUTAMIDE.

  • Radiology response [ Time Frame: 48 months ]
    Evaluate the correlation between radiologic detection response and AR-V7 and / or presence of amplification of the androgen receptor in peripheral blood in patients with CPRC candidates for treatment with ENZALUTAMIDE.

  • frequency changes of AR-V7 [ Time Frame: 48 months ]
    Analyzing changes in the frequency of AR-V7 and / or the presence of amplification androgen receptor in peripheral blood pre- and post-treatment in patients with CPRC candidates for treatment with ENZALUTAMIDE.

  • Prognostic ability of AR-V7 [ Time Frame: 48 months ]
    Studying the prognostic ability of AR-V7 detection and amplification androgen receptor in peripheral blood compared to other serum biomarkers and described tissue, such as testosterone, PTEN loss or presence TMPRSS-ERG fusion among others.


Other Outcome Measures:
  • pronostic nomograms described for CRPC [ Time Frame: 48 months ]
    Validate in this cohort pronostic classic nomograms described previously in CPRC which consist of anatomical and pathological, clinical and analytical variables to be collected during the study

  • prognostic value for overall survival [ Time Frame: 48 months ]
    Validate the prognostic value for overall survival signature expression gene in whole blood from 9-genes described by Olmos et al (Lancet Oncol 2012) in a cohort of patients with CPRC candidates for treatment ENZALUTAMIDE.

  • Prognostic and predictive utility of the expression signature [ Time Frame: 48 months ]
    To analyze the prognostic value to determine response (radiological and PSA) signature of gene expression in whole blood from 9-genes described by Olmos et al (Lancet Oncol 2012) in a cohort of patients with CPRC candidates for ENZALUTAMIDE treatment.

  • Explore new biomarkets [ Time Frame: 48 months ]
    Explore the existence of new biomarkers in whole blood that reflect somatic or germline alterations level associated with tumor dissemination, response and resistance to treatment and prognosis in patients with CPRC included in the study

  • Analyze free circulating DNA and exosomes in selected centers for genomic and genetic studies. [ Time Frame: 48 months ]
    Investigate the feasibility of collecting and analyzing free circulating DNA and exosomes in selected centers for genomic and genetic studies.


Biospecimen Retention:   Samples With DNA
Paxgene and tempus tubes on baeline, pre-cycle 3 and progression Tumor paraffine sample at baseline

Estimated Enrollment: 187
Study Start Date: June 2016
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Enzalutamide
Enzalutamide 160 mg/day continue
Drug: Enzalutamide
Other Name: Xtandi

Detailed Description:
Observational study to analyze prognostic factors in castration resistant prostate cancer patients.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with Castration resistant Prostate Cancer
Criteria

Inclusion Criteria:

  1. Provision of informed consent.
  2. Eighteen years of age or older.
  3. General health status acceptable and compatible with active treatment: ECOG ≤0-2.
  4. Histological confirmation of prostate cancer diagnosis.
  5. Prior resistance to biochemical castration with an LHRH agonist (or surgical castration through bilateral orchiectomy) and progression to an anti-androgen drug (e.g. bicalutamide, nilutamide or cyproterone acetate).
  6. Biochemical progression upon prior treatment in agreement with PSAWG2 criteria, confirmed by a second PSA test.
  7. Castrate levels of testosterone in peripheral blood: testosterone <0.5 ng/ml.
  8. Candidates for standard treatment with enzalutamide: 160 mg continue on cycles of 28 days.
  9. Availability of anatomopathological tumour material (e.g. a paraffin block of the prostatectomy or initial biopsy of the metastasis).
  10. Acceptable hematological, hepatic and renal functions and without contraindications for the administration of abiraterone in agreement with its respective summary of products characteristics.

Exclusion Criteria:

  1. Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free, as well as subjects with a history of skin cancers (of non-melanoma type) or excised in situ carcinomas.
  2. Medical histories, be they psychiatric or of any other character, which, according to the judgement of the investigator, might interfere with the subject's granting of informed consent or the safe execution of the procedures required in the study.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922218


Contacts
Contact: David Olmos, MD 34 91 732 8000 ext 2950 dolmos@cnio.es
Contact: Nuria Romero, MD 34 91 732 8000 ext 2951 prostac@cnio.es

Locations
Spain
Hospital Arquitecto Marcide Recruiting
Ferrol, A Coruña, Spain, 15405
Contact: Javier Afonso, MD    +34981334000    Franciso.Javier.Afonso.Afonso@sergas.es   
Hospital Universitario de Santiago Recruiting
Santiago de Compostela, A Coruña, Spain, 15706
Contact: Urbano Anido, MD    +34981950000    urbanoanido@gmail.com   
ICO L'Hospitalet Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Josep M. Piulats, MD    +34932607780    jmpiulats@iconcologia.net   
Hospital Althaia Manresa Recruiting
Manresa, Barcelona, Spain, 08243
Contact: Montserrat Domenech, MD    +34938759300 ext 3309    mdomenech@althaia.cat   
Hospital de Especialidades de Jerez de la Frontera Recruiting
Jerez de la Frontera, Cádiz, Spain, 11407
Contact: Ruth Viciana, MD    +34956032075    ruthvician@gmail.com   
Hospital Costa del Sol Recruiting
Marbella, Málaga, Spain, 29603
Contact: Rosa Villatoro, MD    +34951976470    villatororoldan@gmail.com   
Complejo Hospitalario de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Nuria Lainez, MD    +34948255400 ext 5870    nuria.lainez.milagro@cfnavarra.es   
Hospital Universitario de Canarias Recruiting
La Laguna, Tenerife, Spain, 38320
Contact: Rosa Delia Garcia, MD    +34922678204    rdgmarrero@gmail.com   
Fundacion Centro Oncologico de Galicia Recruiting
A Coruna, Spain, 15009
Contact: Ana Medina, MD    +34981287499 ext 174    ana.medina@cog.es   
Hospital Universitario Vall D'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Rafael Morales, MD    +34932746000 ext 4695    rafael.morales.barrera@gmail.com   
Hospital de Burgos Recruiting
Burgos, Spain, 09006
Contact: Guillermo Crespo, MD    +34947281978    rescribano@seom.org   
Contact: Ricardo Sanchez, MD    +34947281978    rescribano@seom.org   
Hospital de Ciudad Real Recruiting
Ciudad Real, Spain, 13005
Contact: Jose Carlos Villa, MD    +34926278000 ext 77137    jvillaguzman1@yahoo.es   
Hospital Universitario Reina Sofia Recruiting
Cordoba, Spain, 14004
Contact: Maria Jose Mendez, MD    +34957011147    mjosemv@yahoo.es   
Hospital Universitario Virgen de las Nieves Recruiting
Granada, Spain, 18014
Contact: Raquel Luque, MD    +34958020000    rluquecaro@gmail.com   
Hospital Universitario de Guadalajara Recruiting
Guadalajara, Spain, 19002
Contact: Javier Casinello, MD    +34949209200    jacaes@sescam.jccm.es   
Hospital Universitario Gregorio Maranon Recruiting
Madrid, Spain, 28007
Contact: Jose Angel Arranz, MD    +34914269070    jarranz@oncomed.gmail.com   
Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas Recruiting
Madrid, Spain, 28029
Contact: Nuria Romero, MD    347328000 ext 2951    nromerol@cnio.es   
Contact: Berta Nasarre, PhD       bnasarre@cnio.es   
Sub-Investigator: Leticia Rivera, CRA senior         
Sub-Investigator: Gala Grau, PhD         
Sub-Investigator: Maria Isabel Pacheco, Technician         
Sub-Investigator: Teresa Garces, Technician         
Hospital Universitario Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Javier Puente, MD    +34913303000 ext 7332    docjavip@yahoo.es   
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Daniel Castellanos, MD    +34913908339    cdanicas@hotmail.com   
Centro Integral Oncologico Clara Campal Recruiting
Madrid, Spain, 28050
Contact: Elena Castro, MD    +34917328000 ext 2950    ecastro@hmhospitales.com   
Hospital Regional Universitario Virgen de la Victoria Recruiting
Malaga, Spain, 29010
Contact: Maria Isabel Medina, MD    +34951291425    msaez.med@gmail.com   
Hospital Morales Messeguer Recruiting
Murcia, Spain, 30008
Contact: Enrique Gonzalez, MD    +34968360900 ext 3807    engonbil@um.es   
Hospital Virgen de la Victoria Recruiting
Málaga, Spain, 29010
Contact: David Olmos, MD    34 91 732 8000 ext 2950    dolmos@cnio.es   
Contact: Gala Grau, PhD    34697959726    gala.gala.grau.eecc@gmail.com   
Hospital Son Espases Recruiting
Palma de Mallorca, Spain, 07120
Contact: Aranzazu Gonzalez, MD    +34871206130 ext 76130    aranzazu.gonzalezdealba@ssib.es   
Complejo Hospitalario de Pontevedra Recruiting
Pontevedra, Spain, 36002
Contact: Cristina Azpitarte, MD    +34 986800004    crisazpi@hotmail.com   
Hospital Universitario La Fe Recruiting
Valencia, Spain, 46026
Contact: David Lorente, MD    +34961244000    davlorente@hotmail.com   
Sponsors and Collaborators
Centro Nacional de Investigaciones Oncologicas CARLOS III
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Investigators
Study Chair: David Olmos, MD CNIO-Centro Nacionald e Investigaciones Oncológicas
  More Information

Responsible Party: Centro Nacional de Investigaciones Oncologicas CARLOS III
ClinicalTrials.gov Identifier: NCT02922218     History of Changes
Other Study ID Numbers: CNI-ENZ-2016-01
IBIMA-CNIO-CP-01-2016 ( Other Identifier: CNIO )
First Submitted: September 29, 2016
First Posted: October 4, 2016
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases