At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- enzalutamide (drug), abiraterone acetate (drug), prednisone (drug), Leuprolide acetate (drug)
- How long the study runs
- Study runs about 151 months (dates as stated)
- About the drug or intervention
- enzalutamide — drug: Subjects will receive enzalutamide orally once daily at the same time each day. · abiraterone acetate — drug: Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide · prednisone — drug: Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide · Leuprolide acetate — drug: Subjects enrolling from study MDV3100-13 (EMBARK) study may receive leuprolide acetate once every 12 weeks in addition to enzalutamide once daily
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 900
- Started
- 2016-12-22
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for prostate cancer
- • Phase2 - 900 participants
- • The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with prostate cancer
- • Male only
Where?
- • Bebington - Site GB44009
- • Belfast - Site GB44003
- • Bristol - Site GB44004
- • Cambridge - Site GB44014
- • +7 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.
More detail
Subjects must continue on the treatment regimen that the subject was receiving in the prior study. Dose changes of any of the prior therapies subjects were receiving on the previous protocol are allowed after medical monitor approval. The day 1 visit for this study should coincide with the last treatment visit for the study the subject will be enrolling from (≤ 7 days post last visit of parent study) unless the subject is on treatment suspension. The subjects will be followed according to the local institution's standard of care and will be required to return to the institution every 24 weeks (± 7 days) to review adverse events (AEs), collect concomitant medications and confirm that no discontinuation criteria are met. At each visit and at every 12 weeks (IP only visit) subjects are to return all dispensed study drug and to receive more study drug if applicable. All AEs (new and ongoing from the study the subject is enrolling from) and Serious Adverse Events (SAEs) (including death), will be collected from the time the subject signs the consent form until the end of study visit. After the marketing approval in South Korea, this study continued as "post marketing clinical study" in South Korea. In the rest of the countries which participated in this study, this study continued as clinical study.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Male only
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ to enrollment
- ✓ a negative urine pregnancy test at Day 1
- ✓ additional description of contraceptive methods:
What the study is looking for
- ✓Subject is able to swallow enzalutamide capsules and comply with study requirements.
- ✓Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide...
- ✓Subject agrees not to participate in another interventional study while on treatment.
- ✓Canada Specific:
- ✓Subject is either:
Who cannot take part
- ✗Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical...
- ✗Subject requires treatment with or plans to use either of the following:
- ✗Investigational therapy other than enzalutamide.
- ✗Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
- ✗Canada Specific:
See the full criteria
Where Is This Study? (11 UK sites)
Site GB44009
Bebington, United Kingdom
Site GB44003
Belfast, United Kingdom
Site GB44004
Bristol BS28HW, United Kingdom
Site GB44014
Cambridge, United Kingdom
Site GB44005
Cardiff CF4 4XN, United Kingdom
Site GB44002
Glasgow, United Kingdom
Site GB44006
London, United Kingdom
Site GB44007
Manchester M20 4BX, United Kingdom
Site GB44008
Northwood, United Kingdom
Site GB44016
Nottingham NG5 1PB, United Kingdom
Site GB44001
Sutton, United Kingdom
