Metastatic Castration Resistant Prostate Cancer PatientsPETRUSNCT01786031
Prostate Cancer Evaluation of TaRgets in Genito Urinary Screening Program
A study testing metastasis biopsy in people with Metastatic Castration Resistant Prostate Cancer Patients, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
Toward personalised treatment in early metastatic prostate cancer based on the assessment of biomarkers in cancer tissue samples and circulating tumour cells. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer Patients
- What is being tested?
- metastasis biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Jan 2015
- Phase
- Interventional
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate Cancer patients
- Castration Resistant
- Prostatic tissue available
- Metastasis which may be biopsied
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Toward personalised treatment in early metastatic prostate cancer based on the assessment of biomarkers in cancer tissue samples and circulating tumour cells.
- Being tested
- metastasis biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metastasis biopsyOther
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | metastasis biopsy Receives: Other: metastasis biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker
success to evaluate at least one molecular analysis in tumor tissues (prostate and/or metastatic site) AND in CTC
Measured: assessed at the end of recruitment, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Castration Resistant Prostate Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786031
- Sponsor's protocol ID
- 2012-A00668-35
- Acronym
- PETRUS
- Status last verified
- Feb 2016
- First submitted
- 3 Dec 2012
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lindsay CR, Le Moulec S, Billiot F, Loriot Y, Ngo-Camus M, Vielh P, Fizazi K, Massard C, Farace F. Vimentin and Ki67 expression in circulating tumour cells derived from castrate-resistant prostate cancer. BMC Cancer. 2016 Feb 29;16:168. doi: 10.1186/s12885-016-2192-6.
PubMed 26923772
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Evaluation of TaRgets in Genito Urinary Screening Program
- ClinicalTrials.gov ID
- NCT01786031
- Acronym / sponsor ID
- PETRUS / 2012-A00668-35
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 7 Feb 2013 (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.
Toward personalised treatment in early metastatic prostate cancer based on the assessment of biomarkers in cancer tissue samples and circulating tumour cells.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: metastasis biopsymetastasis biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prostate Cancer patients
- Castration Resistant
- Prostatic tissue available
- Metastasis which may be biopsied
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metastasis biopsy | Other | experimental |
Primary outcome
Biomarker
Time frame: assessed at the end of recruitment, up to 2 years
success to evaluate at least one molecular analysis in tumor tissues (prostate and/or metastatic site) AND in CTC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Derived from this study: PubMed 26923772Lindsay CR, Le Moulec S, Billiot F, Loriot Y, Ngo-Camus M, Vielh P, Fizazi K, Massard C, Farace F. Vimentin and Ki67 expression in circulating tumour cells derived from castrate-resistant prostate cancer. BMC Cancer. 2016 Feb 29;16:168. doi: 10.1186/s12885-016-2192-6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing metastasis biopsy in people with Metastatic Castration Resistant Prostate Cancer Patients, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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 4 inclusion and 0 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: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biomarker (time frame: assessed at the end of recruitment, up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01786031, which also lists 1 linked publication.
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 8 Feb 2016.