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A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
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.
Study details:
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).
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: Male
Things to know
Study dates
Study start: 2016-12-22
Primary completion: 2026-07-31
Study completion finish: 2026-07-31
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT02960022
Intervention or treatment
DRUG: enzalutamide
DRUG: abiraterone acetate
DRUG: prednisone
Conditions
- • Prostate Cancer
Find a site
Closest Location:
Site AU61014
Research sites nearby
Select from list below to view details:
Site AU61014
Albury, New South Wales, Australia
Site AU61001
Tweed Heads, New South Wales, Australia
Site AU61012
Wahroonga, New South Wales, Australia
Site AU61017
Wahroonga, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: enzalutamide
| DRUG: enzalutamide
|
EXPERIMENTAL: enzalutamide plus abiraterone acetate and prednisone
| DRUG: enzalutamide
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Number of participants with adverse events | Not Specified | Until End of Study (Up to 96 Months) |
Secondary outcome
Frequently Asked Questions
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