Metastatic Prostate CancerNCT00213694
PROSTACOX : Metastatic Prostate Chemotherapy
An observational study of Metastatic Prostate Cancer, run by University Hospital, Rouen at 1 site in France.
Trial summary
Clinical response to chemotherapy. Biological parameter (PSA) and RECIST evaluation. Association of Docetaxel (J 15) and Celecoxib. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- docetaxel and celecoxib
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2003to Jun 2006
- 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
Who may be able to join
- metastatic prostate cancer
- ASCO progression criteria
Who cannot join
- other prostate chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Docetaxel (J 15) and Celecoxib in Metastatic Prostate Cancer
Clinical response to chemotherapy. Biological parameter (PSA) and RECIST evaluation. Association of Docetaxel (J 15) and Celecoxib.
Read the detailed description
Association Docetaxel (J 15) and celecoxib Patient survival Biological parameter : PSA Clinical status RECIST evaluation
- Conditions
- Metastatic Prostate Cancer
- Being tested
- docetaxel and celecoxib
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxel and celecoxibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2003
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Time perspective
- Prospective
- Enrolment
- 52 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Investigators
- Christian PFISTER, MD, PhD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213694
- Sponsor's protocol ID
- 2003/052/HP
- Status last verified
- Mar 2013
- First submitted
- 13 Sep 2005
- Last updated
- 5 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Docetaxel (J 15) and Celecoxib in Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT00213694
- Acronym / sponsor ID
- 2003/052/HP
- Conditions
- Metastatic Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Nov 2003
- Study completion
- Jun 2006
- First posted
- 21 Sep 2005 (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.
Clinical response to chemotherapy. Biological parameter (PSA) and RECIST evaluation. Association of Docetaxel (J 15) and Celecoxib.
Detailed description
Association Docetaxel (J 15) and celecoxib Patient survival Biological parameter : PSA Clinical status RECIST evaluation
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- metastatic prostate cancer
- ASCO progression criteria
Key exclusion criteria (1 listed)
- other prostate chemotherapy
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 |
|---|---|---|
| docetaxel and celecoxib | Drug | – |
Primary outcome
Not reported in the source record.
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 5 Mar 2013.
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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.
Christian PFISTER, MD, PhD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Prostate Cancer, run by University Hospital, Rouen 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 2 inclusion and 1 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 5 Mar 2013. 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.
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 5 Mar 2013.