Advanced Prostate CancerPROSENZANCT02922218
PROSENZA: Prospective Multi-Centre Study of Prognostic Factors in mCRPC Patients Treated With Enzalutamide.
An observational study of Advanced Prostate Cancer and Castration Resistant, run by Centro Nacional de Investigaciones Oncologicas CARLOS III at 26 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Advanced Prostate Cancer, Castration Resistant, Enzalutamide
- How many people
- 187 participants
- Where
- 26 sitesSpain
- Study dates
- Jun 2016to 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: metastatic Castration-Resitant Prostate Cancer patients
Who may be able to join
- Male age ≥ 18 years
- Histologically confirmed adenocarcinoma 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 enzalutamide 160 mg every 24 hours.
- 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
26 sites in 1 country.
26 sites in 1 country
Spain26 sites
Fundacion Centro Oncologico de Galicia
A Coruña, 15009
Hospital Universitario Vall D'Hebron
Barcelona, 08035
Hospital de Burgos
Burgos, 09006
Hospital de Ciudad Real
Ciudad Real, 13005
Hospital Universitario Reina Sofia
Córdoba, 14004
Hospital Arquitecto Marcide
Ferrol, A Coruña, 15405
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 Oncologico Clara Campal
Madrid, 28050
Hospital Regional Universitario Virgen de la Victoria
Málaga, 29010
Hospital 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 Enzalutamide.
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
Read the 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.
- Conditions
- Advanced Prostate Cancer, Castration Resistant, Enzalutamide
- Keywords
- metastatic Castration Resistant Prostate Cancer, Enzalutamide, 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 |
|---|---|---|
| Enzalutamide | Enzalutamide 160 mg/day c/24h |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients
Measured: Initially 48 months, currently 60 months
Secondary outcomes (4)
To analyze the correlation between biochemical and/or radiological response with AR-V7 expression and/or AR amplification in mCRPC patients treated with Enzalutamide.
Measured: Initially 48 months, currently 60 months
To assess AR-V7 expression and/or AR amplification changes before and after enzalutamide treatment
Measured: 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
Measured: 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
Measured: Initially 48 months, currently 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2020 (estimated)
- 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
- 187 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Nacional de Investigaciones Oncologicas CARLOS III
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Responsible party
- Sponsor
- Investigators
- David Olmos, MD, Study chair, CNIO-Centro Nacionald e Investigaciones Oncológicas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922218
- Sponsor's protocol ID
- IBIMA-CNIO-CP-01-2016
- Other IDs
- CNI-ENZ-2016-01
- Acronym
- PROSENZA
- Status last verified
- Jan 2020
- First submitted
- 29 Sep 2016
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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 Enzalutamide.
- ClinicalTrials.gov ID
- NCT02922218
- Acronym / sponsor ID
- PROSENZA / IBIMA-CNIO-CP-01-2016
- Conditions
- Advanced Prostate Cancer, Castration Resistant, Enzalutamide
- Keywords
- metastatic Castration Resistant Prostate Cancer, Enzalutamide, Biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 187 participants (estimated)
- Lead sponsor
- Centro Nacional de Investigaciones Oncologicas CARLOS IIIUniversity, hospital or other
- Collaborators
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Study start
- Jun 2016
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 Oct 2016 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide | – | –Enzalutamide 160 mg/day c/24h |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- metastatic Castration-Resitant Prostate Cancer patients
Key inclusion criteria (9 listed)
- Male age ≥ 18 years
- Histologically confirmed adenocarcinoma 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 assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients
Time frame: Initially 48 months, currently 60 months
4 secondary outcomes
To analyze the correlation between biochemical and/or radiological response with AR-V7 expression and/or AR amplification in mCRPC patients treated with Enzalutamide.
Time frame: Initially 48 months, currently 60 months
To assess AR-V7 expression and/or AR amplification changes before and after enzalutamide treatment
Time frame: 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
Time frame: 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
Time frame: Initially 48 months, currently 60 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.
- Individual participant dataSharing planned: No
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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 study chair
CNIO-Centro Nacionald e Investigaciones Oncológicas
26 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 Castration Resistant, run by Centro Nacional de Investigaciones Oncologicas CARLOS III at 26 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 26 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 assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients (time frame: Initially 48 months, currently 60 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.