Prostatic NeoplasmsPORTREATNCT01076751
Observational Registry of Treatment Patterns in Castrate-resistant Prostate Cancer (CRPC) Patients
An observational study of Prostatic Neoplasms, run by Sanofi at 5 sites in 5 countries.
Trial summary
Primary Objective: Describe real-life survival of CRPC patients who received first-line docetaxel and have disease progression Secondary Objective: Describe treatment patterns Describe the characteristics and outcomes of patients who received second-line taxane-based treatment compared to others Describe economic and… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms
- How many people
- 82 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Feb 2010to Oct 2010
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with metastatic castrate-resistant prostate cancer
Who may be able to join
- Patients with CRPC progressing during the course of first line docetaxel-based chemotherapy or after at least 3 cycles (equivalent to 225mg/m2) of first line docetaxel-based chemotherapy
- Patient who have given their written consent
Who cannot join
- Current participation in a clinical trial for the second-line treatment of prostate cancer
- Patients having received less than 3 cycles of first line docetaxel-based chemotherapy and discontinued for a reason other than disease progression or toxicity
- Patients having already started a second line treatment
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford Surrey
About this study
Official title: Observational Prospective Study of Survival, Treatment Patterns, Disease and Economic Outcomes in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Progression During or After a First-line Docetaxel-based Regimen
Primary Objective:
- Describe real-life survival of CRPC patients who received first-line docetaxel and have disease progression
Secondary Objective:
- Describe treatment patterns
- Describe the characteristics and outcomes of patients who received second-line taxane-based treatment compared to others
- Describe economic and patient-reported outcomes
- Conditions
- Prostatic Neoplasms
- Medical subject headings
- Prostatic Neoplasms
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 |
|---|---|---|
| CRPC patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: At Month 12 or death
Secondary outcomes (4)
Sequence of treatment in second-line, third-line
Measured: At Month 6 (+/- 2 months), Month 12 or death
Characteristics and outcomes of patients who receive second-line taxane-based treatment compared to others
Measured: At baseline, Month 6 (+/- 2 months), Month 12 or death
Indicators of health care resource utilization
Measured: At baseline, Month 6 (+/- 2 months), Month 12 or death
Quality of life
Measured: At baseline, Month 6 (+/- 2 months) or Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: delay in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076751
- Sponsor's protocol ID
- DIREG_C_05073
- Acronym
- PORTREAT
- Status last verified
- Feb 2011
- First submitted
- 25 Feb 2010
- Last updated
- 14 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Study of Survival, Treatment Patterns, Disease and Economic Outcomes in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Progression During or After a First-line Docetaxel-based Regimen
- ClinicalTrials.gov ID
- NCT01076751
- Acronym / sponsor ID
- PORTREAT / DIREG_C_05073
- Conditions
- Prostatic Neoplasms
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: delay in recruitment
- Enrolment
- 82 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 26 Feb 2010 (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.
Primary Objective:
- Describe real-life survival of CRPC patients who received first-line docetaxel and have disease progression
Secondary Objective:
- Describe treatment patterns
- Describe the characteristics and outcomes of patients who received second-line taxane-based treatment compared to others
- Describe economic and patient-reported outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRPC patients | – | – |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with metastatic castrate-resistant prostate cancer
Key inclusion criteria (2 listed)
- Patients with CRPC progressing during the course of first line docetaxel-based chemotherapy or after at least 3 cycles (equivalent to 225mg/m2) of first line docetaxel-based chemotherapy
- Patient who have given their written consent
Key exclusion criteria (4 listed)
- Current participation in a clinical trial for the second-line treatment of prostate cancer
- Patients having received less than 3 cycles of first line docetaxel-based chemotherapy and discontinued for a reason other than disease progression or toxicity
- Patients having already started a second line treatment
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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
Overall survival
Time frame: At Month 12 or death
4 secondary outcomes
Sequence of treatment in second-line, third-line
Time frame: At Month 6 (+/- 2 months), Month 12 or death
Characteristics and outcomes of patients who receive second-line taxane-based treatment compared to others
Time frame: At baseline, Month 6 (+/- 2 months), Month 12 or death
Indicators of health care resource utilization
Time frame: At baseline, Month 6 (+/- 2 months), Month 12 or death
Quality of life
Time frame: At baseline, Month 6 (+/- 2 months) or Month 12
Results and safety
The study was stopped early (reason given: delay in recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2011.
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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.
Clinical Sciences & Operations study director
Sanofi
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, run by Sanofi at 5 sites in 5 countries.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 14 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, France, Germany, Spain, United Kingdom. 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 was stopped early (reason given: delay in recruitment). 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?
Overall survival (time frame: At Month 12 or death). 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 14 Feb 2011.