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Poster display session

4642 - PROSENZA: Prospective multi-centre study of prognostic factors in castration resistant prostate cancer (CRPC) patients treated with Enzalutamide (ENZ)

Date

10 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Prostate Cancer

Presenters

Ana Medina

Citation

Annals of Oncology (2017) 28 (suppl_5): v269-v294. 10.1093/annonc/mdx370

Authors

A. Medina1, A. Montesa2, N. Romero Laorden3, E. Gonzalez-Billalabeitia3, A. Rodriguez-Vida4, G. Grau2, T. Garcés3, R. Morales Barrera5, F.J. Vazquez Mazon6, R. Villatoro7, M.A. Gonzalez Del Alba Baamonde8, F. López9, S. Hernando Polo10, M. Domenech11, G. de Velasco12, P. Borrega13, R. Querol14, E. Velez15, E. Castro Marcos16, D. Olmos Hidalgo3

Author affiliations

  • 1 Medical Oncology, Centro Oncológico de Galicia, 15009 - A Coruña/ES
  • 2 Cnio-ibima Genitourinary Research Unit, Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Málaga/ES
  • 3 Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre, 28029 - Madrid/ES
  • 4 Medical Oncology, University Hospital del Mar, 8003 - Barcelona/ES
  • 5 Medical Oncology, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 6 Medical Oncology, Hospital General Universitario de Elche, 3203 - Elche/ES
  • 7 Medical Oncology, Hospital Costa del Sol, Málaga/ES
  • 8 Medical Oncology, Hospital Universitario Son Espases, 7010 - Palma de Mallorca/ES
  • 9 Radiation Oncology, Hospital Universitario Ramon y Cajal, 28031 - Madrid/ES
  • 10 Medical Oncology, HUFA Hospital Universitario Fundacion Alcorcon, 28922 - Alcorcon/ES
  • 11 Medical Oncology, Hospital Althaia Manresa, Manresa/ES
  • 12 Medical Oncology, Hospital Univesitario 12 de Octubre, Madrid/ES
  • 13 Medical Oncology, H. San pedro de Alcántara, 10003 - Cáceres/ES
  • 14 Medical Oncology, Consorci Sanitari del Maresme, Mataró/ES
  • 15 Medical Oncology, Hospital de San Pedro, Logroño/ES
  • 16 Prostate Cancer Unit, Spanish National Cancer Center, 28029 - Madrid/ES
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Resources

Abstract 4642

Background

CRPC is a heterogeneous disease, and despite new agents approved, the optimal sequence of treatment remains unclear, far from personalised medicine that may offer the maximal benefit for the patient. For that reason, our aim is the identification of new biomarkers in CRPC patients treated with conventional therapy.

Trial design

PROSENZA is a prospective multicentre observational study in metastatic CRPC designed to explore biomarkers in patients treated with ENZ. Key inclusion criteria: a) histological confirmation of prostate cancer; b) documented criteria (PCWG2) for CRPC; c) availability of tumour tissue; d) candidate for standard treatment with ENZ. Primary end point: to study the prognostic value for overall survival (OS) of the detection of androgen receptor splicing variant 7 (AR-V7) and/or amplification of AR (AR+) in peripheral blood in this cohort. Secondary end points: a) to analyse the correlation between PSA response and AR-V7 and/or AR+; b) to evaluate the correlation between radiological response and AR-V7 and/or AR+; c) to study changes in AR-V7 frequency and/or AR+ pre and post ENZ; d) to analyse and correlate the prognostic role of AR-V7 and AR+ with other biomarkers as testosterone serum levels, PTENloss or TMPRSS-ERG fusions. Exploratory outcomes: a) to validate in this cohort prognostic nomograms described for CRPC; b) to validate the prognostic role of the expression signature described by Olmos et al (Lancet Oncol 2012) in peripheral blood; c)to explore new somatic and germinal variants in peripheral blood and tissue associated to dissemination, response and resistance to ENZ. PROSENZA is part of the PROCURE Biomarkers network, a multicentric spanish platform for biomarkers discovery in CRPC. 187 patients will be accrued to provide appropriate statistical power to detect at least 71 events (deaths) to analyse the main outcome. Currently, 48 centres are active for recruitment and 54 patients have been included. Blood samples are collected before, during and after progression to ENZ Prospective data collection will be linked. This study may help to incorporate new biomarkers in clinical practice and improve the selection of therapy in mCRPC.

Clinical trial identification

NCT02922218

Legal entity responsible for the study

Spanish National Cancer Research Centre

Funding

Partially funded by Astellas

Disclosure

A. Medina: Honoraria from Astellas. All other authors have declared no conflicts of interest.

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