Metastatic Prostate AdenocarcinomaOPALENCT03611686
Observatory of Patients With Metastatic ProstAte Adenocarcinoma That is Resistant to Castration and Multi-LinE Strategies
An observational study of Metastatic Prostate Adenocarcinoma, run by University Hospital, Rouen at 1 site in France.
Trial summary
Evaluation the overall survival of patients with metastatic prostate adenocarcinoma resistant to castration Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Adenocarcinoma
- What is being tested?
- Local chemotherapy
- How many people
- 219 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2018to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with metastatic prostate adenocarcinoma resistant to castration
Who may be able to join
- Patient monitored for castration-resistant metastatic prostate
- Patients starting a first or second line treatment as part of castration resistance
- Patient not objecting to the study after reading the information letter
- Patient aged over 18 years
Who cannot join
- Patient monitored for non-metastatic prostate cancer
- Patient monitored for castration-nonresistant prostate cancer
- Patient not able to understand the information letter
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation the overall survival of patients with metastatic prostate adenocarcinoma resistant to castration
- Conditions
- Metastatic Prostate Adenocarcinoma
- Being tested
- Local chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local chemotherapyDrug
Local chemotherapy will be administrated according to local recommendation
| Study group | Role | What they receive |
|---|---|---|
| patient followed for metastatic prostate adenocarcinoma | patient wil be followed for metastatic prostate adenocarcinoma during 3 years Receives: Drug: Local chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of alive patient
Measured: 3 years
Secondary outcomes (1)
Number of alive patient disease free
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start17 Apr 2018
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate AdenocarcinomaStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian PFISTER, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611686
- Sponsor's protocol ID
- 2017/090/HP
- Acronym
- OPALE
- Status last verified
- Mar 2025
- First submitted
- 26 Jul 2018
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observatory of Patients With Metastatic ProstAte Adenocarcinoma That is Resistant to Castration and Multi-LinE Strategies
- ClinicalTrials.gov ID
- NCT03611686
- Acronym / sponsor ID
- OPALE / 2017/090/HP
- Conditions
- Metastatic Prostate Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 219 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 2 Aug 2018 (actual)
- 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.
Evaluation the overall survival of patients with metastatic prostate adenocarcinoma resistant to castration
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient followed for metastatic prostate adenocarcinoma | – | Drug: Local chemotherapypatient wil be followed for metastatic prostate adenocarcinoma during 3 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic prostate adenocarcinoma resistant to castration
Key inclusion criteria (4 listed)
- Patient monitored for castration-resistant metastatic prostate
- Patients starting a first or second line treatment as part of castration resistance
- Patient not objecting to the study after reading the information letter
- Patient aged over 18 years
Key exclusion criteria (3 listed)
- Patient monitored for non-metastatic prostate cancer
- Patient monitored for castration-nonresistant prostate cancer
- Patient not able to understand the information letter
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 |
|---|---|---|
| Local chemotherapyLocal chemotherapy will be administrated according to local recommendation | Drug | patient followed for metastatic prostate adenocarcinoma |
Primary outcome
Number of alive patient
Time frame: 3 years
1 secondary outcome
Number of alive patient disease free
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- 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.
Christian PFISTER 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 Adenocarcinoma, 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of alive patient (time frame: 3 years). 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 24 Mar 2025.