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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02922218
Other study ID # IBIMA-CNIO-CP-01-2016
Secondary ID CNI-ENZ-2016-01
Status Active, not recruiting
Phase
First received
Last updated
Start date June 2016
Est. completion date December 2020

Study information

Verified date January 2020
Source Centro Nacional de Investigaciones Oncologicas CARLOS III
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 187
Est. completion date December 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Locations

Country Name City State
Spain Fundacion Centro Oncologico de Galicia A Coruna
Spain Hospital Universitario Vall D'Hebron Barcelona
Spain Hospital de Burgos Burgos
Spain Hospital de Ciudad Real Ciudad Real
Spain Hospital Universitario Reina Sofia Cordoba
Spain Hospital Arquitecto Marcide Ferrol A Coruña
Spain Hospital Universitario Virgen de las Nieves Granada
Spain Hospital Universitario de Guadalajara Guadalajara
Spain Hospital de Especialidades de Jerez de la Frontera Jerez de la Frontera Cádiz
Spain ICO L'Hospitalet L'Hospitalet de Llobregat Barcelona
Spain Hospital Universitario de Canarias La Laguna Tenerife
Spain Centro Integral Oncologico Clara Campal Madrid
Spain Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Clinico San Carlos Madrid
Spain Hospital Universitario Gregorio Maranon Madrid
Spain Hospital Regional Universitario Virgen de la Victoria Malaga
Spain Hospital Virgen de la Victoria Málaga
Spain Hospital Althaia Manresa Manresa Barcelona
Spain Hospital Costa del Sol Marbella Málaga
Spain Hospital Morales Messeguer Murcia
Spain Hospital Son Espases Palma de Mallorca
Spain Complejo Hospitalario de Navarra Pamplona Navarra
Spain Complejo Hospitalario de Pontevedra Pontevedra
Spain Hospital Universitario de Santiago Santiago de Compostela A Coruña
Spain Hospital Universitario La Fe Valencia

Sponsors (2)

Lead Sponsor Collaborator
Centro Nacional de Investigaciones Oncologicas CARLOS III Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients Initially 48 months, currently 60 months
Primary 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 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
Secondary To assess AR-V7 expression and/or AR amplification changes before and after enzalutamide treatment Initially 48 months, currently 60 months
Secondary 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
Secondary 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
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