Castration-resistant Prostate CancerNCT02669771
Long-Term Specified Drug Use-Results Survey for Xtandi Capsule
An observational study of Castration-resistant Prostate Cancer, run by Astellas Pharma Inc at 47 sites in Japan.
Trial summary
The purpose of this study is to confirm the long term safety and efficacy of enzalutamide in patients. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Castration-resistant Prostate Cancer
- What is being tested?
- enzalutamide
- Type of treatment
- Pill or oral medicine
- How many people
- 1,018 participants
- Where
- 47 sitesJapan
- Study dates
- 30 Nov 2014to 30 Nov 2018
- 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 castration-resistant prostate cancer
Who may be able to join
- no history of treatment with enzalutamide
Who cannot join
- -
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Japan47 sites
Study site
Aichi
Study site
Akita
Study site
Aomori
Study site
Chiba
Study site
Ehime
Study site
Fukui
Study site
Fukuoka
Study site
Fukushima
Study site
Gifu
Study site
Gunma
Study site
Hiroshima
Study site
Hokkaido
Study site
Hyōgo
Study site
Ibaraki
Study site
Ishikawa
Study site
Kagawa
Study site
Kagoshima
Study site
Kanagawa
Study site
Kochi
Study site
Kumamoto
Study site
Kyoto
Study site
Mie
Study site
Miyagi
Study site
Miyazaki
Study site
Nagano
Study site
Nagasaki
Study site
Nara
Study site
Niigata
Study site
Numakunai, Iwate
Study site
Ōita
Study site
Okayama
Study site
Okinawa
Study site
Osaka
Study site
Saga
Study site
Saitama
Study site
Shiga
Study site
Shimane
Study site
Shizuoka
Study site
Tochigi
Study site
Tokushima
Study site
Tokyo
Study site
Tottori
Study site
Toyama
Study site
Wakayama
Study site
Yamagata
Study site
Yamaguchi
Study site
Yamanashi
About this study
Official title: Xtandi® Capsules 40 mg Protocol for Long-Term Specified Drug Use-Results Survey
The purpose of this study is to confirm the long term safety and efficacy of enzalutamide in patients.
- Conditions
- Castration-resistant Prostate Cancer
- Being tested
- enzalutamide
- Keywords
- Xtandi, MDV3100, long term use, enzalutamide
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
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide group | oral Receives: Drug: enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of Adverse Events
Measured: Up to 2 years
Secondary outcomes (2)
Overall Survival
Measured: Up to 2 years
Change from baseline in PSA value
PSA: prostate-specific antigen
Measured: 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 posted1 Feb 2016 (estimated)
- Study start30 Nov 2014
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 1,018 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669771
- Sponsor's protocol ID
- 9785-MA-1018
- Status last verified
- Nov 2024
- First submitted
- 28 Jan 2016
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- 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/.
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
- Xtandi® Capsules 40 mg Protocol for Long-Term Specified Drug Use-Results Survey
- ClinicalTrials.gov ID
- NCT02669771
- Acronym / sponsor ID
- 9785-MA-1018
- Conditions
- Castration-resistant Prostate Cancer
- Keywords
- Xtandi, MDV3100, long term use, enzalutamide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,018 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 30 Nov 2014 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 1 Feb 2016 (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.
The purpose of this study is to confirm the long term safety and efficacy of enzalutamide in patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide group | – | Drug: enzalutamideoral |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with castration-resistant prostate cancer
Key inclusion criteria (1 listed)
- no history of treatment with enzalutamide
Key exclusion criteria (1 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 |
|---|---|---|
| enzalutamideAlso: Xtandi, MDV3100oral | Drug | Enzalutamide group |
Primary outcome
Incidences of Adverse Events
Time frame: Up to 2 years
2 secondary outcomes
Overall Survival
Time frame: Up to 2 years
Change from baseline in PSA value
Time frame: Up to 2 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.
- 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/.
Related trials for Castration-resistant Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
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 Director study director
Astellas Pharma Inc
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Castration-resistant Prostate Cancer, run by Astellas Pharma Inc at 47 sites in Japan.
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 1 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 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 47 sites in Japan. 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?
Incidences of Adverse Events (time frame: Up to 2 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 21 Nov 2024.