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

• Conditions: Castration Resistant; Advanced Prostate Cancer; Enzalutamide

• Registration Number: NCT02922218
• Lead Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III

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

Detailed 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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-30
• Study First Posted: 2016-10-04
• Status Verified: 2020-01
• Primary Completion: 2020-01
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 187

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these patients	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

Trial Locations

Locations (26)

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital Universitario Vall D'Hebron; 🇪🇸 Barcelona, Spain

ICO L'Hospitalet; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Son Espases; 🇪🇸 Palma de Mallorca, Spain

Hospital Universitario Gregorio Maranon; 🇪🇸 Madrid, Spain

Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas; 🇪🇸 Madrid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Arquitecto Marcide; 🇪🇸 Ferrol, A Coruña, Spain

Hospital Universitario de Santiago; 🇪🇸 Santiago de Compostela, A Coruña, Spain

Hospital de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Universitario de Guadalajara; 🇪🇸 Guadalajara, Spain

Hospital Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital Regional Universitario Virgen de la Victoria; 🇪🇸 Malaga, Spain

Hospital Costa del Sol; 🇪🇸 Marbella, Málaga, Spain

Hospital Universitario de Canarias; 🇪🇸 La Laguna, Tenerife, Spain

Fundacion Centro Oncologico de Galicia; 🇪🇸 A Coruna, Spain

Hospital de Burgos; 🇪🇸 Burgos, Spain

Hospital Morales Messeguer; 🇪🇸 Murcia, Spain

Complejo Hospitalario de Pontevedra; 🇪🇸 Pontevedra, Spain

Hospital Althaia Manresa; 🇪🇸 Manresa, Barcelona, Spain

Hospital de Especialidades de Jerez de la Frontera; 🇪🇸 Jerez de la Frontera, Cádiz, Spain

Hospital Universitario Reina Sofia; 🇪🇸 Cordoba, Spain

Hospital Universitario Clinico San Carlos; 🇪🇸 Madrid, Spain

Centro Integral Oncologico Clara Campal; 🇪🇸 Madrid, Spain

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain