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

Advanced Prostate Cancer Clinical Trial

— PROSENZA  

Official title:

Prospective Multi-Centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Enzalutamide.

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
• 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
• 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

Related Conditions & MeSH terms

• Advanced Prostate Cancer
• Castration Resistant
• Enzalutamide
• Prostatic Neoplasms

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