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

January 23, 2020 updated by: Centro Nacional de Investigaciones Oncologicas CARLOS III

Prospective Multi-centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Docetaxel or Cabazitaxel.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
402

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruna, Spain, 15009
        • Fundacion Centro Oncologico de Galicia
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Ciudad Real, Spain, 13005
        • Hospital de Ciudad Real
      • Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • Guadalajara, Spain, 19002
        • Hospital Universitario de Guadalajara
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28040
        • Hospital Universitario Clinico San Carlos
      • Madrid, Spain, 28007
        • Hospital Universitario Gregorio Marañón
      • Madrid, Spain, 28050
        • Centro Integral Oncologico Clara Campal
      • Madrid, Spain, 28029
        • Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas
      • Malaga, Spain, 29010
        • Anatomical Pathology PROCURE
      • Malaga, Spain, 29010
        • Hospital Regional Universitario Virgen de la Victoria
      • Murcia, Spain, 30008
        • Hospital Morales Messeguer
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Palma de Mallorca, Spain, 07120
        • Hospital Son Espases
      • Pontevedra, Spain, 36002
        • Complejo Hospitalario de Pontevedra
      • Valencia, Spain, 46026
        • Hospital Universitario La Fe
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Hospital Universitario de Santiago
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • ICO l'Hospitalet
      • Manresa, Barcelona, Spain, 08243
        • Hospital Althaia Manresa
    • Cádiz
      • Jerez de la Frontera, Cádiz, Spain, 11407
        • Hospital de Especialidades de Jerez de La Frontera
    • Málaga
      • Marbella, Málaga, Spain, 29603
        • Hospital Costa del Sol
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Complejo Hospitalario de Navarra
    • Tenerife
      • La Laguna, Tenerife, Spain, 38320
        • Hospital Universitario de Canarias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Castration-Resistant Prostate Cancer patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Docetaxel
Docetaxel 75mg/m2 IV every 3 weeks
Cabazitaxel
Cabazitaxel 20-25mg/m2 IV every 3 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Time Frame: 48 months
48 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To analyze the prognostic value of the gene-expression signature described by Olmos et al on biochemical and radiological progression-free survival
Time Frame: 48 months
48 months
To analyze the prognostic value of early changes in the gene-expression signature described by Olmos et al
Time Frame: 48 months
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)
Time Frame: 48 months
48 months
To validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these both cohorts of patients
Time Frame: 48 months
48 months
To analyze the prognostic value of TMPRSS2-ERG rearrengement and PTEN loss in these cohorts
Time Frame: 48 months
48 months
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
Time Frame: 48 months
48 months
To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients
Time Frame: 48 months
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centro Nacional de Investigaciones Oncologicas CARLOS III

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Olmos, MD, PhD, Head of Prostate Cancer Clinical Research Unit CNIO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CNI-DOC-2014-02
  • CNIO-CP-02-2014 (Other Identifier: CNIO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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