PROSTAC: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Docetaxel or Cabazitaxel.

• Conditions: Advanced Prostate Cancer; Cabazitaxel; Docetaxel

• Registration Number: NCT02362620
• Lead Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III

Brief Summary

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

Detailed Description

This study is a prospective biomarker study of patients with mCRPC undergoing treatment with docetaxel or cabazitaxel 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: 2014-05
• Study First Submitted: 2015-02-09
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-13
• Primary Completion: 2018-04
• Status Verified: 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: 402

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 docetaxel 75mg/m2 every 3 weeks or cabazitaxel 20-25mg/m2 every 3 weeks intravenously.
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 validate the prognostic value of the gene-expression signature from peripheral blood described by Olmos et al (Lancet Oncol 2012) on overall survival of mCRPC patients	48 months

Secondary Outcome Measures

Name	Time	Method
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	48 months
To analyze the prognostic value of the gene-expression signature described by Olmos et al on biochemical and radiological progression-free survival	48 months
To analyze the prognostic value of early changes in the gene-expression signature described by Olmos et al	48 months
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)	48 months
To validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these both cohorts of patients	48 months
To analyze the prognostic value of TMPRSS2-ERG rearrengement and PTEN loss in these cohorts	48 months
To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients	48 months

Trial Locations

Locations (25)

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

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

Hospital Althaia Manresa; 🇪🇸 Manresa, Barcelona, Spain

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

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

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

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

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

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

Hospital Universitario Gregorio Maranon; 🇪🇸 Madrid, Spain

Hospital de Ciudad Real; 🇪🇸 Ciudad Real, Spain

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

Hospital Universitario de Guadalajara; 🇪🇸 Guadalajara, Spain

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

Hospital Universitario Reina Sofia; 🇪🇸 Cordoba, Spain

Hospital Universitario Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Centro Integral Oncológico Clara Campal; 🇪🇸 Madrid, Spain

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

Anatomical Pathology PROCURE; 🇪🇸 Malaga, Spain

Hospital Morales Messeguer; 🇪🇸 Murcia, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain

Complejo Hospitalario de Pontevedra; 🇪🇸 Pontevedra, Spain

Hospital Son Espases; 🇪🇸 Palma de Mallorca, Spain

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain