Advanced Prostate CancerPROSTACNCT02362620
PROSTAC: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Docetaxel or Cabazitaxel.
An observational study of Advanced Prostate Cancer and Cabazitaxel, run by Centro Nacional de Investigaciones Oncologicas CARLOS III at 25 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Advanced Prostate Cancer, Cabazitaxel, Docetaxel
- Type of treatment
- Injection or infusion
- How many people
- 402 participants
- Where
- 25 sitesSpain
- Study dates
- May 2014to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Castration-Resistant Prostate Cancer patients
Who may be able to join
- Male age ≥ 18 years
- Histologically confirmed adenocarcinome of the prostate
- ECOG Performance Status ≤ 2
- Castration resistance must be documented with surgical or medical castration with serum testosterone < 50 ng/mL (< 2.0 nM).
- Men diagnosed with at least one metastatic lesion on CT or bone scan.
- Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria.
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- 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.
- Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy.
- Acceptable hematological, hepatic and renal functions.
Who cannot join
- 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.
- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Spain25 sites
Fundacion Centro Oncologico de Galicia
A Coruña, 15009
Hospital Universitario Vall D'Hebron
Barcelona, 08035
Hospital de Ciudad Real
Ciudad Real, 13005
Hospital Universitario Reina Sofia
Córdoba, 14004
Hospital Universitario Virgen de las Nieves
Granada, 18014
Hospital Universitario de Guadalajara
Guadalajara, 19002
Hospital de Especialidades de Jerez de la Frontera
Jerez de la Frontera, Cádiz, 11407
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario Gregorio Maranon
Madrid, 28007
Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas
Madrid, 28029
Hospital Universitario Clinico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Centro Integral Oncológico Clara Campal
Madrid, 28050
Anatomical Pathology PROCURE
Málaga, 29010
Hospital Regional Universitario Virgen de la Victoria
Málaga, 29010
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital Althaia Manresa
Manresa, Barcelona, 08243
Hospital Costa del Sol
Marbella, Málaga, 29603
Hospital Morales Messeguer
Murcia, 30008
Hospital Son Espases
Palma de Mallorca, 07120
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008
Complejo Hospitalario de Pontevedra
Pontevedra, 36002
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
Hospital Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
Hospital Universitario La Fe
Valencia, 46026
About this study
Official title: 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
Read the 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.
- Conditions
- Advanced Prostate Cancer, Cabazitaxel, Docetaxel
- Keywords
- metastatic Castration Resistant Prostate Cancer, Taxanes, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel | Docetaxel 75mg/m2 IV every 3 weeks | |
| Cabazitaxel | Cabazitaxel 20-25mg/m2 IV every 3 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 months
Secondary outcomes (7)
To analyze the prognostic value of the gene-expression signature described by Olmos et al on biochemical and radiological progression-free survival
Measured: 48 months
To analyze the prognostic value of early changes in the gene-expression signature described by Olmos et al
Measured: 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)
Measured: 48 months
To validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these both cohorts of patients
Measured: 48 months
To analyze the prognostic value of TMPRSS2-ERG rearrengement and PTEN loss in these cohorts
Measured: 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
Measured: 48 months
To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startMay 2014
- Primary completionApr 2018
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Nacional de Investigaciones Oncologicas CARLOS III
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Olmos, MD, PhD, Principal investigator, Head of Prostate Cancer Clinical Research Unit CNIO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362620
- Sponsor's protocol ID
- CNI-DOC-2014-02
- Other IDs
- CNIO-CP-02-2014
- Acronym
- PROSTAC
- Status last verified
- Jan 2020
- First submitted
- 9 Feb 2015
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Docetaxel or Cabazitaxel.
- ClinicalTrials.gov ID
- NCT02362620
- Acronym / sponsor ID
- PROSTAC / CNI-DOC-2014-02
- Conditions
- Advanced Prostate Cancer, Cabazitaxel, Docetaxel
- Keywords
- metastatic Castration Resistant Prostate Cancer, Taxanes, Biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- Centro Nacional de Investigaciones Oncologicas CARLOS IIIUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2018 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel | – | –Docetaxel 75mg/m2 IV every 3 weeks |
| Cabazitaxel | – | –Cabazitaxel 20-25mg/m2 IV every 3 weeks |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Castration-Resistant Prostate Cancer patients
Key inclusion criteria (9 listed)
- Male age ≥ 18 years
- Histologically confirmed adenocarcinome of the prostate
- ECOG Performance Status ≤ 2
- Castration resistance must be documented with surgical or medical castration with serum testosterone < 50 ng/mL (< 2.0 nM).
- Men diagnosed with at least one metastatic lesion on CT or bone scan.
Key exclusion criteria (2 listed)
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
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
To analyze the prognostic value of early changes in the gene-expression signature described by Olmos et al
Time frame: 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
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
To analyze the prognostic value of TMPRSS2-ERG rearrengement and PTEN loss in these cohorts
Time frame: 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
To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Olmos, MD, PhD principal investigator
Head of Prostate Cancer Clinical Research Unit CNIO
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Prostate Cancer and Cabazitaxel, run by Centro Nacional de Investigaciones Oncologicas CARLOS III at 25 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.