Metastatic Castration Resistant Prostate CancerNCT03328364
A Registry Based Study Evaluating Overall Survival and Treatment Length in mCRPC Patients Treated With Enzalutamide in Sweden
An observational study of Metastatic Castration Resistant Prostate Cancer, run by Astellas Pharma a/s at 1 site in Sweden.
Trial summary
The purpose of this study is to provide real world data on treatment with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) patients. The primary purpose is to evaluate overall survival (OS) in mCRPC patients treated with enzalutamide who have previously undergone treatment with chemotherapy… 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
- What is being tested?
- enzalutamide and docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 211 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2017to 24 Dec 2017
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mCRPC initiating treatment with enzalutamide pre- and post- chemo registered in the prostate cancer registry.
Who may be able to join
- Chemo naïve mCRPC patients treated with enzalutamide and ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration).
- mCRPC patients treated with enzalutamide and ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration) post chemo.
Who cannot join
- mCRPC patients previously exposed to Radium-223, abiraterone acetate and/or cabazitaxel for mCRPC (pre- and post chemotherapy).
- Patients previously exposed to chemotherapy or abiraterone acetate+prednisolone in combination with GnRH analogue for hormone sensitive prostate cancer (HSPC).
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to provide real world data on treatment with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) patients.
The primary purpose is to evaluate overall survival (OS) in mCRPC patients treated with enzalutamide who have previously undergone treatment with chemotherapy (docetaxel) (post chemo patients).
This study will also evaluate treatment duration with enzalutamide in patients pre- and post-chemo.
Read the detailed description
The data source in this study is a local hospital registry created from a patient follow up of prostate cancer patients.
- Being tested
- enzalutamide, docetaxel
- Keywords
- enzalutamide, metastatic castration-resistant prostate cancer, Xtandi, registry based study, MDV3100, mCRPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enzalutamideDrug
Also called Xtandi, MDV3100
oral
docetaxelDrug
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| enzalutamide (mCRPC pre-chemo) | Patients treated with enzalutamide prior to chemotherapy Receives: Drug: enzalutamide | |
| enzalutamide and chemotherapy (mCRPC post chemo) | Patients treated with enzalutamide who have previously undergone treatment with chemotherapy (docetaxel) Receives: Drug: enzalutamide; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival in metastatic castration-resistant prostate cancer (mCRPC) patients treated with enzalutamide, who have previously undergone treatment with chemotherapy (docetaxel)
Overall survival is defined as time from initiation to death of any cause.
Measured: Up to a maximum of four years
Secondary outcomes (2)
Treatment duration of enzalutamide in pre chemo mCRPC patients
Treatment duration is defined as time from initiation to treatment discontinuation of any cause.
Measured: Up to a maximum of four years
Treatment duration of enzalutamide in post chemo mCRPC patients
Treatment duration is defined as time from initiation to treatment discontinuation of any cause.
Measured: Up to a maximum of four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start1 Dec 2017
- Primary completion24 Dec 2017
- Study completion24 Dec 2017
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 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
- Retrospective
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma a/s
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Scientific Advisor, Study chair, Astellas Pharma a/s
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328364
- Sponsor's protocol ID
- 9785-MA-3166
- Status last verified
- Nov 2024
- First submitted
- 30 Oct 2017
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Alghazali M, Lofgren A, Jorgensen L, Svensson M, Fagerlund K, Bjartell A. A registry-based study evaluating overall survival and treatment duration in Swedish patients with metastatic castration-resistant prostate cancer treated with enzalutamide. Scand J Urol. 2019 Oct;53(5):312-318. doi: 10.1080/21681805.2019.1657494. Epub 2019 Sep 6.
PubMed 31815592
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Based Study Evaluating Overall Survival and Treatment Length in mCRPC Patients Treated With Enzalutamide in Sweden
- ClinicalTrials.gov ID
- NCT03328364
- Acronym / sponsor ID
- 9785-MA-3166
- Keywords
- enzalutamide, metastatic castration-resistant prostate cancer, Xtandi, registry based study, MDV3100, mCRPC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Astellas Pharma a/sIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 24 Dec 2017 (actual)
- Study completion
- 24 Dec 2017 (actual)
- First posted
- 1 Nov 2017 (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.
The purpose of this study is to provide real world data on treatment with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) patients.
The primary purpose is to evaluate overall survival (OS) in mCRPC patients treated with enzalutamide who have previously undergone treatment with chemotherapy (docetaxel) (post chemo patients).
This study will also evaluate treatment duration with enzalutamide in patients pre- and post-chemo.
Detailed description
The data source in this study is a local hospital registry created from a patient follow up of prostate cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enzalutamide (mCRPC pre-chemo) | – | Drug: enzalutamidePatients treated with enzalutamide prior to chemotherapy |
| enzalutamide and chemotherapy (mCRPC post chemo) | – | Drug: enzalutamide, Drug: docetaxelPatients treated with enzalutamide who have previously undergone treatment with chemotherapy (docetaxel) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mCRPC initiating treatment with enzalutamide pre- and post- chemo registered in the prostate cancer registry.
Key inclusion criteria (2 listed)
- Chemo naïve mCRPC patients treated with enzalutamide and ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration).
- mCRPC patients treated with enzalutamide and ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration) post chemo.
Key exclusion criteria (2 listed)
- mCRPC patients previously exposed to Radium-223, abiraterone acetate and/or cabazitaxel for mCRPC (pre- and post chemotherapy).
- Patients previously exposed to chemotherapy or abiraterone acetate+prednisolone in combination with GnRH analogue for hormone sensitive prostate cancer (HSPC).
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 |
|---|---|---|
| enzalutamideAlso: Xtandi, MDV3100oral | Drug | enzalutamide (mCRPC pre-chemo), enzalutamide and chemotherapy (mCRPC post chemo) |
| docetaxelintravenous infusion | Drug | enzalutamide and chemotherapy (mCRPC post chemo) |
Primary outcome
Overall survival in metastatic castration-resistant prostate cancer (mCRPC) patients treated with enzalutamide, who have previously undergone treatment with chemotherapy (docetaxel)
Time frame: Up to a maximum of four years
Overall survival is defined as time from initiation to death of any cause.
2 secondary outcomes
Treatment duration of enzalutamide in pre chemo mCRPC patients
Time frame: Up to a maximum of four years
Treatment duration of enzalutamide in post chemo mCRPC patients
Time frame: Up to a maximum of four years
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 21 Nov 2024.
- Derived from this study: PubMed 31815592Alghazali M, Lofgren A, Jorgensen L, Svensson M, Fagerlund K, Bjartell A. A registry-based study evaluating overall survival and treatment duration in Swedish patients with metastatic castration-resistant prostate cancer treated with enzalutamide. Scand J Urol. 2019 Oct;53(5):312-318. doi: 10.1080/21681805.2019.1657494. Epub 2019 Sep 6.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Medical Scientific Advisor study chair
Astellas Pharma a/s
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 Castration Resistant Prostate Cancer, run by Astellas Pharma a/s at 1 site in Sweden.
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 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: finished, as of the sponsor's last update on 21 Nov 2024. 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 Sweden. 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?
Overall survival in metastatic castration-resistant prostate cancer (mCRPC) patients treated with enzalutamide, who have previously undergone treatment with chemotherapy (docetaxel) (time frame: Up to a maximum of four 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 NCT03328364, 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 21 Nov 2024; AzTrials last refreshed its copy on 31 Oct 2026.