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ACTIVE NOT RECRUITINGPhase2

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Sponsor: Astellas Pharma Global Development, Inc.

NCT ID: NCT02960022

View on ClinicalTrials.gov ↗

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.

Prostate Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

have a negativemet

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
Inclusion Criteria: * Subject must currently be receiving enzalutamide or assigned to receive enzalutamide (if on treatment suspension) for prostate cancer in a study sponsored by Astellas or Medivation and, based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible. * Subject is able to continue on the treatment regimen that they were receiving or were assigned to receive in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dose change in Androgen deprivation therapy (ADT) or dropping of a combination therapy) approval from a medical monitor is required prior to enrollment. * Subject is able to swallow enzalutamide capsules and comply with study requirements. * Subject and female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective and 1 must be a barrier method throughout the study and for 3 months after final enzalutamide administration. * Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration. * Subject agrees not to participate in another interventional study while on treatment. Canada Specific: * Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization for the United States sites) must be obtained from the subject prior to any study-related procedures. * Subject must currently be receiving enzalutamide for breast cancer in a study sponsored by Astellas or Medivation/Pfizer and based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible. * Subject is able to continue on the treatment regimen that they were receiving in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dropping of a combination therapy) approval from a medical monitor is required prior to enrollment. * Subject is able to swallow enzalutamide capsules and comply with study requirements. * Subject is either: * Of nonchildbearing potential: * postmenopausal (defined as no spontaneous menses for at least 12 months prior to Day 1 with follicle stimulating hormone (FSH) \> 40 IU/L at Day 1 for women \< 55 years of age), * documented surgically sterile or status post hysterectomy (at least 1 month prior to Day 1), * Or, if of childbearing potential, * must have a negative urine pregnancy test at Day 1 before the first dose of study drug is administered, * must use 2 acceptable methods of birth control starting at Day 1 and through 6 months after the final study drug administration, * must not donate ova starting at first administration of study intervention and throughout 6 months after final study intervention administration. The 2 acceptable methods of birth control are as follows or per local guidelines where these require additional description of contraceptive methods: * A barrier method (e.g., condom by a male partner) is required; AND * One of the following is required: * Placement of an intrauterine device (IUD) or intrauterine system (IUS); * Additional barrier method including occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; * Vasectomy or other surgical castration at least 6 months before Day 1. * The subject must not be breastfeeding at Day 1 or during the study period, and for 6 months after the final study drug administration. * Subject agrees not to participate in another interventional study while on treatment. Exclusion Criteria: * Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is enrolling from. * Subject requires treatment with or plans to use either of the following: * New systemic therapy for subjects cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment. * Investigational therapy other than enzalutamide. * Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide. * Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data. Canada Specific: Subject will be excluded from participation if any of the following apply: * Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which they are enrolling from. * Subject requires treatment with or plans to use any of the following: * New systemic therapy for their cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment. * Investigational therapy other than enzalutamide. * Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide. * Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data in the opinion of the investigator.

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

Data sourced from ClinicalTrials.gov · Last verified: 2026-09