enzalutamide: Subjects will receive enzalutamide orally once daily at the same time each day.
abiraterone acetate: 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: 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: Subjects enrolling from study MDV3100-13 (EMBARK) study may receive leuprolide acetate once every 12 weeks in addition to enzalutamide once daily
Study summary
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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of participants with adverse events — Until End of Study (Up to 96 Months)
Trial sites (234)
Facility
City
Region
Status
Site US10052
Anchorage
Alaska
Site US10011
Tucson
Arizona
Site US10040
Los Angeles
California
Site US10009
Los Angeles
California
Site US10008
San Bernardino
California
Site US10042
San Diego
California
Site US10028
Stanford
California
Site US10001
Aurora
Colorado
Site US10017
Denver
Colorado
Site US10050
Washington D.C.
District of Columbia
Site US10049
Daytona Beach
Florida
Site US10002
Chicago
Illinois
Springfield Clinic, LLP
Springfield
Illinois
Site US10007
Jeffersonville
Indiana
University of Kansas Medical Center
Kansas City
Kansas
Site US10066
Lenexa
Kansas
Site US10029
Towson
Maryland
Site US10032
St Louis
Missouri
Nebraska Medical Hospital
Omaha
Nebraska
Site US10023
Omaha
Nebraska
Site US10004
Hackensack
New Jersey
Site US10024
Garden City
New York
Site US10055
New York
New York
Site US10059
New York
New York
Hudson Valley Urology, PC
Poughkeepsie
New York
Site US10053
Syracuse
New York
Site US10030
Chapel Hill
North Carolina
Site US10062
Charlotte
North Carolina
Site US10031
Greensboro
North Carolina
Eastern Urological Associates
Greenville
North Carolina
Site US10046
Winston-Salem
North Carolina
Site US10035
Cincinnati
Ohio
Site US10022
Springfield
Oregon
Site US10027
Lancaster
Pennsylvania
Site US10005
Pittsburgh
Pennsylvania
Site US10018
Charleston
South Carolina
Carolina Urologic Research Center
Myrtle Beach
South Carolina
Site US10041
Nashville
Tennessee
Site US10010
Dallas
Texas
Site US10034
Houston
Texas
+ 194 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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