PROSABI: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Abiraterone Acetate.

Advanced Prostate Cancer Clinical Trial

— PROSABI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02787837
• Other study ID #: CNIO-CP-03-2014
• Secondary ID: CNI-ABI-2014-02
• Status: Active, not recruiting
• Start date: May 2014
• 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

PROSABI is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with abiraterone

Description:

This study is a prospective biomarker study of patients with mCRPC undergoing treatment with abiraterone 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: 220
• Est. completion date: December 2020
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Male age = 18 years

2. Histologically confirmed adenocarcinome 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 abiraterone acetate:

1000 mg every 24 hours plus prednisone 5 mg every 12 hours.

8. Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy.

9. Acceptable hematological, hepatic and renal functions.9. Acceptable haematological, 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

• Abiraterone ACetate
• Advanced Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
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 Madrid Sanchinarro	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Clinico San Carlos	Madrid
Spain	Hospital Universitario Gregorio Maranon	Madrid
Spain	Anatomical Pathology PROCURE-PROSABI	Malaga
Spain	Hospital Regional Universitario Virgen de la Victoria	Malaga
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 Pontevedra	Pontevedra
Spain	Hospital Universitario de Santiago	Santiago de Compostela	A Coruña
Spain	Hospital Universitario La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Centro Nacional de Investigaciones Oncologicas CARLOS III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	To analyze the prognostic value of the gene-expression signature described by Olmos et al on biochemical and radiological progression-free survival		Initially 48 months, currently 60 months
Secondary	To analyze the prognostic value of early changes in the gene-expression signature described by Olmos et al		Initially 48 months, currently 60 months
Secondary	To compare the prognostic value of the gene-expression signature described by Olmos et al versus the gene-expression signature described by Ross et al (Lancet Oncol, 2012)		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
Secondary	To analyze the prognostic value of TMPRSS2-ERG rearrengement and PTEN loss in these cohorts		Initially 48 months, currently 60 months
Secondary	To analyze the prognostic value of AR splicing variants, serum chromogranine and serum testosterone levels measured by ultrasensitive method in these both cohorts of patients		Initially 48 months, currently 60 months
Secondary	To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients		Initially 48 months, currently 60 months